PF-06372865 In Subjects With Chronic Low Back Pain

• Sponsor: Pfizer (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02262754
• Collaborator: (none)
• Enrollment: 302
• Locations: 46
• Arms: 3
• Duration (Months): 10
• Patients Per Site: 6.6
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

PF-06372865 In Subjects With Chronic Low Back Pain

Condition or Disease	Intervention/Treatment	Phase
Chronic Low Back Pain	Drug: PF-06372865; Drug: Placebo; Drug: Naproxen	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 302 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double Blind, Placebo- And Active-controlled, 4 Week, Multi-center, Parallel Group Study Assessing The Analgesic Effect, Safety And Tolerability Of Pf-06372865 In Subjects With Chronic Low Back Pain Using Naproxen As Positive Control
• Study Start Date: Oct 1, 2014
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PF-06372865 Daily BID dosing for 4 weeks	Drug: PF-06372865; Dose level 1 daily dosing BID for 1 week followed by dose level 2 daily BID for 3 weeks
Placebo Comparator: Placebo Daily BID dosing for 4 weeks	Drug: Placebo; Placebo for PF-06372865 and placebo for naproxen daily
Active Comparator: Naproxen Daily BID dosing for 4 weeks	Drug: Naproxen; 500 mg BID for 4 weeks

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Daily Low Back Pain Intensity (LBPI) Score as Measured by an 11-point Numeric Rating Scale (NRS) at Week 4 [Baseline, Week 4]

   Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. Baseline value was calculated as the mean of the scores over the last 7 days in the placebo run-in period, prior to randomization. Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.

2. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to 28 days after the last dose of study treatment (Day 56)]

   An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.

3. Number of Participants With Laboratory Abnormalities [Baseline up to 28 days after the last dose of study treatment (Day 56)]

   Abnormality criteria included: hemoglobin, hematocrit and red blood cells (RBCs) (less than [<] 0.8*lower limit of normal [LLN]); white blood cells (WBC) (<0.6*LLN, greater than [>] 1.5*upper limit of normal [ULN]); MCV, MCH, MCHC (<0.9*LLN, >1.1*ULN); platelets (<0.5*LLN>, >1.75*ULN); neutrophils, lymphocytes(<0.8*LLN, >1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin (>1.5*ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (>3*ULN); total protein, albumin (<0.8*LLN, >1.2*ULN); creatinine, blood urea nitrogen (>1.3*ULN); glucose (<0.6*LLN, >1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN, >1.1*ULN); urine pH (<4.5, >8); qualitative urine glucose, ketones, protein, blood values (greater than or equal to [>=] 1) in urine dipstick test; urine RBC, WBC (>=20); hyaline casts (>1), bacteria (>20).

4. Number of Participants With Vital Sign Abnormalities [Baseline up to Follow-up (44 days)]

   Participants who met the criteria for abnormal findings in vital signs data were reported. Criteria for abnormalities in vital signs: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm) or >120 bpm. Maximum increase or decrease from baseline in supine SBP >=30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.

5. Number of Participants With Electrocardiogram (ECG) Abnormalities [Baseline up to Follow-up (44 days)]

   Participants with abnormal ECG findings were reported. Criteria for potential clinical concern in ECG parameters: maximum (max.) PR interval of >=300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia's Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum of >=25 percent (%) increase from baseline (IFB) value of >200 msec and >=50% for baseline value of less than or equal to (<=) 200 msec for PR interval, maximum increase from baseline of >=50% for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia's Correction).

6. Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS) [Screening, Baseline, Week 1, 2, 3, 4]

   The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide =1, suicide attempt =2 (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior =3 ("Yes" on "preparatory acts or behavior"), suicidal ideation =4 ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior =7 ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").

7. Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit [End of treatment (Day 30), follow-up (Day 44)]

   PWC is a 20 item physician rated interview to measure anxiolytic drug withdrawal-related signs and symptoms. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition. PWC total score range from 0 (not present) to 60 (severe), where higher score = more affected condition. Change: score at follow-up visit minus score at the end of treatment visit.

Secondary Outcome Measures

1. Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4 [Baseline, Week 1, 2, 3, 4]

   Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.

2. Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4 [Baseline, Week 1, 2, 3, 4]

   Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.

3. Number of Participants With Sustained Response Rates in Daily Average LBPI NRS Scores at Greater Than or Equal to (>=) 30 Percent and >=50 Percent Reduction From Baseline [Baseline up to Week 4]

   Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10. Percentage of reduction from baseline in the daily average LBPI NRS score was calculated as: ([daily value - baseline value] divided by baseline value) multiplied by 100. Number of participants with sustained response rates (for a minimum of 4 consecutive days) in the daily average LBPI NRS scores that were at >=30 percent and >=50 percent reduced from baseline were reported.

4. Number of Participants Withdrawn Due to Lack of Efficacy [Baseline up to Week 4]

   Participants withdrew from the study due to lack of efficacy (insufficient clinical response) were reported.

5. Time to Withdrawal Due to Lack of Efficacy [Baseline up to Week 4]

   Kaplan Meier and Cox Proportional Hazards analyses were to be used to compute the time to withdrawal due to lack of efficacy. Withdrawal due to lack of efficacy was identified from the participant summary case report form (CRF) page and where reason was identified as "Insufficient Clinical Response". Time to withdrawal was calculated as Date of withdrawal - Date of Randomization.

6. Number of Participants Using Rescue Medication [Week 1, 2, 3, 4]

   Participants were permitted to use any commercial product (tablet/caplet/capsule) of acetaminophen (paracetamol) 500 mg as a rescue medication. Number of participants who used rescue medication were reported.

7. Number of Days Participants Used the Rescue Medication [Week 1, 2, 3, 4]

   The number of days for which the participants used the rescue medication were reported. Participants recorded the usage of acetaminophen rescue medication in the daily diary.

8. Amount of Rescue Medication Used by the Participants [Week 1, 2, 3, 4]

   The amount of rescue medication (Acetaminophen [paracetamol]) used was reported. Participants were permitted to use any commercial product of acetaminophen tablet/caplet/capsule.

9. Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3 [Baseline, Week 1, 2, 3]

   Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.

10. Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4 [Baseline, Week 4]

    Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.

11. Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4 [Baseline, Week 2, Week 4]

    This test assesses verbal learning and memory. Participants are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate learning trials. The total recall score ranges from 0 (no memory) to 36 (best memory) while the delayed recall trial score ranges from 0 (no memory) to 12 (best memory); higher scores indicated greater verbal learning and recall.

12. Chronic Low Back Pain (CLBP) Responder Index Analysis [Week 1, 2, 3, 4]

    Participants were successful responders if they had any of the following: >=30 percent reduction in mean daily average LBPI from baseline to particular week; decrease of >=30 percent in participant's global assessment of low back pain (disease activity) from baseline to particular week or no worsening (increase) in RMDQ total score from baseline to particular week.

13. Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4 [Baseline, Week 1, 2, 3, 4]

    Participant rated 5-point Likert scale ranging from 0 (no pain) to 4 (worst possible pain) with a higher score indicating greater level of pain.

14. Patient Global Impression of Change (PGI-C) Score [Week 1, 2, 3, 4]

    PGI-C was a participant rated instrument to measure participant's assessment of change in his or her overall status since the previous visit on a 7-point scale; ranging from 1 (very much improved) to 7 (very much worse), where higher scores indicated more worsening.

15. Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4 [Week 4]

    Participants rated their study treatment by GESM questionnaire. It was a qualitative measure of efficacy utilizing a 4-point Likert scale ranging from 1 (poor) to 4 (excellent), where higher score indicated a better overall response to the treatment. Number of participants who reported a particular score had been reported.

16. Plasma Concentration of PF-06372865 [Baseline, Week 1, 2, 3, 4]

    Data was calculated by setting concentration values below the lower limit of quantification (LLOQ) to zero. The LLOQ was <0.0100 nanogram per milliliter (ng/mL).

17. Plasma Concentration of Naproxen [Baseline, Week 1, 2, 3, 4]

    Data was calculated by setting concentration values below the LLOQ to zero. The LLOQ was <1000 ng/mL.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Agave Clinical Research, LLC	Mesa	Arizona	United States	85202
2	Arizona Research Center, Inc.	Phoenix	Arizona	United States	85023
3	Global Research	Anaheim	California	United States	92804
4	Neuro-Pain Medical Center	Fresno	California	United States	93710
5	Providence Clinical Research	North Hollywood	California	United States	91606
6	Elite Clinical Trials, Incorporate	Wildomar	California	United States	92595
7	Stamford Therapeutics Consortium	Stamford	Connecticut	United States	06905
8	Avail Clinical Research, LLC	DeLand	Florida	United States	32720
9	S&W Clinical Research	Fort Lauderdale	Florida	United States	33306
10	Florida Research Network, LLC	Gainesville	Florida	United States	32605
11	Broward Research Group	Hollywood	Florida	United States	33024
12	Jacksonville Center for Clinical Research	Jacksonville	Florida	United States	32216
13	Compass Research, LLC	Orlando	Florida	United States	32806
14	Pines Clinical Research Inc.	Pembroke Pines	Florida	United States	33028
15	Accord Clinical Research, LLC	Port Orange	Florida	United States	32129
16	Arthritis & Rheumatic Care Center	South Miami	Florida	United States	33143
17	Miami Research Associates	South Miami	Florida	United States	33143
18	Better Health Clinical Research, Inc.	Atlanta	Georgia	United States	30344
19	River Birch Research Alliance, LLC	Blue Ridge	Georgia	United States	30513
20	Family Medicine center	Columbus	Georgia	United States	31901
21	Columbus Regional Research Institute	Columbus	Georgia	United States	31904
22	Drug Studies America	Marietta	Georgia	United States	30060
23	Better Health Clinical Research, Inc./Georgia Pain & Spine Care, Inc.	Newnan	Georgia	United States	30265
24	Better Health Clinical Research, Inc.	Newnan	Georgia	United States	30265
25	Southeast Regional Research Group	Savannah	Georgia	United States	31405
26	North Georgia Clinical Research	Woodstock	Georgia	United States	30189
27	North Georgia Internal medicine	Woodstock	Georgia	United States	30189
28	Chicago Anesthesia Associates	Chicago	Illinois	United States	60657
29	Centex Studies, Inc	Lake Charles	Louisiana	United States	70601
30	Boston Clinical Trials	Boston	Massachusetts	United States	02131
31	ActivMed Practices & Research, Inc.	Methuen	Massachusetts	United States	01844
32	CRC of Jackson	Jackson	Mississippi	United States	39202
33	Physician's Surgery Center	Jackson	Mississippi	United States	39202
34	Drug Trials America	Hartsdale	New York	United States	10530
35	AAIR Research Center	Rochester	New York	United States	14618
36	Wake Internal Medicine Consultants, Inc.	Raleigh	North Carolina	United States	27612
37	Wake Research Associates, LLC	Raleigh	North Carolina	United States	27612
38	The Center for Clinical Research	Winston-Salem	North Carolina	United States	27103
39	Summit Research Network (Oregon), Inc.	Portland	Oregon	United States	97210
40	Altoona Center for Clinical Research	Duncansville	Pennsylvania	United States	16635
41	Omega Medical Research	Warwick	Rhode Island	United States	02886
42	Clinical Trial Network	Houston	Texas	United States	77074
43	Lee Medical Associates, PA	San Antonio	Texas	United States	78229
44	Progressive Clinical Research	San Antonio	Texas	United States	78229
45	National Clinical Research - Norfolk, Inc.	Norfolk	Virginia	United States	23502
46	Summit Research Network (Seattle) LLC	Seattle	Washington	United States	98104

Sponsors and Collaborators

• Pfizer

Investigators

• Study Director: Pfizer CT.gov Call Center, Pfizer

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• To obtain contact information for a study center near you, click here.

Publications

None provided.

• Responsible Party: Pfizer
• ClinicalTrials.gov Identifier: NCT02262754
• Other Study ID Numbers: B7431006
• First Posted: Oct 13, 2014
• Last Update Posted: Jan 4, 2017
• Last Verified: Nov 1, 2016

• Additional relevant MeSH terms: Back Pain; Low Back Pain; Naproxen; PF-06372865

Study Results

Participant Flow

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Period Title: Overall Study
STARTED	74	74	74
COMPLETED	58	65	65
NOT COMPLETED	16	9	9

Baseline Characteristics

Arm/Group Title	Placebo	PF-06372865	Naproxen	Total
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.	Total of all reporting groups
Overall Participants	74	74	74	222
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	51.1 (12.1)	49.7 (13.8)	51.6 (13.1)	50.8 (12.9)
Gender (Count of Participants)
FEMALE	38 51.4%	39 52.7%	37 50%	114 51.4%
MALE	36 48.6%	35 47.3%	37 50%	108 48.6%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Daily Low Back Pain Intensity (LBPI) Score as Measured by an 11-point Numeric Rating Scale (NRS) at Week 4
Description	Daily average low back pain was assessed on an 11-point numeric rating scale (NRS). Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain. Baseline value was calculated as the mean of the scores over the last 7 days in the placebo run-in period, prior to randomization. Post-baseline weekly scores were calculated based on the mean of the scores over the 7 days prior to and including the day at the end of the corresponding week.
Time Frame	Baseline, Week 4

Outcome Measure Data

Analysis Population Description

FAS included all participants randomized and who had received at least 1 dose of randomized treatment.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
Mean (90% Confidence Interval) [units on a scale]	-1.19 (1.351)	-1.03 (1.091)	-1.45 (1.401)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	An analysis of covariance (ANCOVA) model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward (LOCF) was used for missing data.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (PF-06372865-Placebo)
	Estimated Value	0.16
	Confidence Interval	(2-Sided) 90%; -0.28 to 0.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward LOCF was used for missing data.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (PF-06372865-Naproxen)
	Estimated Value	0.42
	Confidence Interval	(2-Sided) 90%; -0.02 to 0.87
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-2.36, 0.542^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. A last observation carried forward LOCF was used for missing data.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.26
	Confidence Interval	(2-Sided) 90%; -0.70 to 0.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Primary Outcome

Title	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description	An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. The SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pretreatment state. AEs included both serious and non-serious adverse events.
Time Frame	Baseline up to 28 days after the last dose of study treatment (Day 56)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least 1 dose of study treatment.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
AEs	26 (1.351) 35.1%	34 (1.091) 45.9%	28 (1.401) 37.8%
SAEs	1 1.4%	1 1.4%	2 2.7%

3. Primary Outcome

Title	Number of Participants With Laboratory Abnormalities
Description	Abnormality criteria included: hemoglobin, hematocrit and red blood cells (RBCs) (less than [<] 0.8*lower limit of normal [LLN]); white blood cells (WBC) (<0.6*LLN, greater than [>] 1.5*upper limit of normal [ULN]); MCV, MCH, MCHC (<0.9*LLN, >1.1*ULN); platelets (<0.5*LLN>, >1.75*ULN); neutrophils, lymphocytes(<0.8*LLN, >1.2*ULN); eosinophils, basophils, monocytes (>1.2*ULN); total bilirubin (>1.5*ULN); aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase (>3*ULN); total protein, albumin (<0.8*LLN, >1.2*ULN); creatinine, blood urea nitrogen (>1.3*ULN); glucose (<0.6*LLN, >1.5*ULN); uric acid (>1.2*ULN); sodium, potassium, chloride, calcium, bicarbonate (<0.9*LLN, >1.1*ULN); urine pH (<4.5, >8); qualitative urine glucose, ketones, protein, blood values (greater than or equal to [>=] 1) in urine dipstick test; urine RBC, WBC (>=20); hyaline casts (>1), bacteria (>20).
Time Frame	Baseline up to 28 days after the last dose of study treatment (Day 56)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least 1 dose of study treatment. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	73	74	74
Number [participants]	26 35.1%	44 59.5%	41 55.4%

4. Primary Outcome

Title	Number of Participants With Vital Sign Abnormalities
Description	Participants who met the criteria for abnormal findings in vital signs data were reported. Criteria for abnormalities in vital signs: supine systolic blood pressure (SBP) <90 millimeter of mercury (mmHg), supine diastolic BP (DBP) <50 mmHg, supine pulse rate <40 beats per minute (bpm) or >120 bpm. Maximum increase or decrease from baseline in supine SBP >=30 mmHg and maximum increase or decrease from baseline in supine DBP >=20 mmHg.
Time Frame	Baseline up to Follow-up (44 days)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least 1 dose of study treatment.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
Supine SBP: <90 mmHg	0 (1.351) 0%	1 (1.091) 1.4%	0 (1.401) 0%
Supine DBP: <50 mmHg	0 0%	1 1.4%	0 0%
Supine pulse rate: <40 bpm	0 0%	0 0%	0 0%
Supine pulse rate: >120 bpm	0 0%	0 0%	0 0%
Maximum increase in Supine SBP: >=30 mmHg	5 6.8%	0 0%	1 1.4%
Maximum increase in Supine DBP: >=20 mmHg	6 8.1%	3 4.1%	4 5.4%
Maximum decrease in Supine SBP: >=30 mmHg	1 1.4%	6 8.1%	4 5.4%
Maximum decrease in Supine DBP: >=20 mmHg	3 4.1%	9 12.2%	3 4.1%

5. Primary Outcome

Title	Number of Participants With Electrocardiogram (ECG) Abnormalities
Description	Participants with abnormal ECG findings were reported. Criteria for potential clinical concern in ECG parameters: maximum (max.) PR interval of >=300 milliseconds (msec), maximum QRS interval >=140 msec, maximum QTCF interval (Fridericia's Correction) of 450 to <480 msec, 480 to <500 msec and >=500 msec, maximum of >=25 percent (%) increase from baseline (IFB) value of >200 msec and >=50% for baseline value of less than or equal to (<=) 200 msec for PR interval, maximum increase from baseline of >=50% for QRS interval, maximum increase from baseline of >=30 msec to <60 msec and maximum increase from baseline of >60 msec in QTCF interval (Fridericia's Correction).
Time Frame	Baseline up to Follow-up (44 days)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least 1 dose of study treatment. Here, "n" signifies the number of participants evaluable for the specific category.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
Max. PR Interval: >=300 msec (n=72, 74, 72)	0 (1.351) 0%	0 (1.091) 0%	0 (1.401) 0%
Max. QRS Complex: >=140 msec (n=72, 74, 72)	0 0%	0 0%	1 1.4%
Max. QTCF Interval: 450 to <480 msec (n=72,74,72)	1 1.4%	1 1.4%	2 2.7%
Max. QTCF Interval: 480 to <500 msec (n=72,74,72)	0 0%	1 1.4%	0 0%
Max. QTCF Interval: >=500 msec (n=72, 74, 72)	0 0%	0 0%	0 0%
Max. PR Interval IFB: >=25 or 50% (n=72, 74, 71)	1 1.4%	0 0%	0 0%
Max. QRS Complex IFB: >=50% (n=72, 74, 72)	1 1.4%	0 0%	1 1.4%
Max. QTCF Interval IFB: 30 to<60 msec (n=72,74,72)	3 4.1%	4 5.4%	0 0%
Max. QTCF Interval IFB: >=60 msec (n=72,74,72)	3 4.1%	1 1.4%	0 0%

6. Primary Outcome

Title	Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale (C-SSRS)
Description	The C-SSRS (mapped to Columbia Classification Algorithm of Suicide Assessment [C-CASA]) is an interview-based rating scale to systematically assess suicidal ideation and suicidal behavior. C-SSRS assessed whether participant experienced following: completed suicide =1, suicide attempt =2 (response of "Yes" on "actual attempt"), preparatory acts toward imminent suicidal behavior =3 ("Yes" on "preparatory acts or behavior"), suicidal ideation =4 ("Yes" on "wish to be dead", "non-specific active suicidal thoughts", "active suicidal ideation with methods without intent to act or some intent to act, without specific plan or with specific plan and intent), any suicidal behavior or ideation, self-injurious behavior =7 ("Yes" on "Has participant engaged in non-suicidal self-injurious behavior").
Time Frame	Screening, Baseline, Week 1, 2, 3, 4

Outcome Measure Data

Analysis Population Description

Data was not collected for this outcome measure as per study team's decision, since it was a semi-structured interview and was difficult to pull accurate scores from it.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	0	0	0

7. Primary Outcome

Title	Change From End of Treatment Visit in Physician's Withdrawal Checklist (PWC) Score at Follow-up Visit
Description	PWC is a 20 item physician rated interview to measure anxiolytic drug withdrawal-related signs and symptoms. Each individual item score ranges from 0 (not present) to 3 (severe), where higher scores = more affected condition. PWC total score range from 0 (not present) to 60 (severe), where higher score = more affected condition. Change: score at follow-up visit minus score at the end of treatment visit.
Time Frame	End of treatment (Day 30), follow-up (Day 44)

Outcome Measure Data

Analysis Population Description

Safety analysis set included all participants who received at least 1 dose of study treatment.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
Least Squares Mean (90% Confidence Interval) [units on a scale]	-0.11 (1.351)	-0.34 (1.091)	0.01 (1.401)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	The ANCOVA model included treatment as fixed effects.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	-0.23
	Confidence Interval	(2-Sided) 90%; -0.76 to 0.30
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.32
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	The ANCOVA model included treatment as fixed effects.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 90%; -0.41 to 0.65
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.32
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	The ANCOVA model included treatment as fixed effects.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	-0.35
	Confidence Interval	(2-Sided) 90%; -0.87 to 0.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.32
	Estimation Comments

8. Secondary Outcome

Title	Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2 3 and 4
Description	Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.
Time Frame	Baseline, Week 1, 2, 3, 4

Outcome Measure Data

Analysis Population Description

FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, "n" signifies participants who were evaluable at the specified time point for each arm.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
Change at week 1 (n= 74, 74, 74)	-0.50 (1.351)	-0.41 (1.091)	-0.70 (1.401)
Change at week 2 (n= 65, 70, 72)	-0.93	-0.98	-1.17
Change at week 3 (n= 62, 69, 70)	-1.12	-1.09	-1.39
Change at week 4 (n= 59, 64, 66)	-1.22	-1.14	-1.58

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	0.08
	Confidence Interval	(2-Sided) 90%; -0.20 to 0.36
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.17
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.20
	Confidence Interval	(2-Sided) 90%; -0.48 to 0.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.17
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.28
	Confidence Interval	(2-Sided) 90%; 0.01 to 0.56
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.17
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	-0.05
	Confidence Interval	(2-Sided) 90%; -0.43 to 0.34
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.24
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.24
	Confidence Interval	(2-Sided) 90%; -0.62 to 0.15
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.19
	Confidence Interval	(2-Sided) 90%; -0.19 to 0.58
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.23
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 90%; -0.39 to 0.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.27
	Confidence Interval	(2-Sided) 90%; -0.69 to 0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.26
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.30
	Confidence Interval	() 90%; -0.12 to 0.71
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.25
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	0.07
	Confidence Interval	(2-Sided) 90%; -0.40 to 0.55
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.37
	Confidence Interval	(2-Sided) 90%; -0.84 to 0.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.29
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.44
	Confidence Interval	(2-Sided) 90%; -0.03 to 0.91
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.28
	Estimation Comments

9. Secondary Outcome

Title	Percent Change From Baseline in Daily Low Back Pain Intensity (LBPI) as Measured by an 11-point Numeric Rating Scale (NRS) at Week 1, 2, 3 and 4
Description	Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10.
Time Frame	Baseline, Week 1, 2, 3, 4

Outcome Measure Data

Analysis Population Description

FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, "n" signifies participants who were evaluable at the specified time point for each arm.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
Change at week 1 (n= 74, 74, 74)	-7.453 (18.2639)	-5.830 (16.0979)	-10.601 (17.4139)
Change at week 2 (n= 65, 70, 72)	-15.190 (21.7655)	-15.467 (20.4505)	-17.682 (24.3704)
Change at week 3 (n= 62, 69, 70)	-19.100 (25.5461)	-17.167 (23.7288)	-22.204 (23.2540)
Change at week 4 (n= 59, 64, 66)	-20.958 (25.5848)	-17.072 (27.4016)	-23.906 (28.0190)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 1: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	0.03
	Confidence Interval	(2-Sided) 90%; -0.03 to 0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.03
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 1: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.04
	Confidence Interval	(2-Sided) 90%; -0.09 to 0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.03
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 1: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 90%; 0.01 to 0.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.03
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 2: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 90%; -0.09 to 0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 2: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.05
	Confidence Interval	(2-Sided) 90%; -0.15 to 0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 2: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 90%; -0.04 to 0.15
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.06
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 3: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	0.00
	Confidence Interval	(2-Sided) 90%; -0.12 to 0.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.07
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 3: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.05
	Confidence Interval	(2-Sided) 90%; -0.16 to 0.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.07
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 3: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.05
	Confidence Interval	(2-Sided) 90%; -0.07 to 0.16
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.07
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 4: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	-0.01
	Confidence Interval	(2-Sided) 90%; -0.16 to 0.14
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.09
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 4: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.10
	Confidence Interval	(2-Sided) 90%; -0.24 to 0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.09
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 4: The mixed effect repeated measures model includes treatment, week and the week*treatment interaction as fixed effects, week repeated within each subject as a repeated effect and log baseline as a response. LS Mean Difference and 90 percent confidence interval was calculated from log values.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.09
	Confidence Interval	(2-Sided) 90%; -0.05 to 0.23
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.09
	Estimation Comments

10. Secondary Outcome

Title	Number of Participants With Sustained Response Rates in Daily Average LBPI NRS Scores at Greater Than or Equal to (>=) 30 Percent and >=50 Percent Reduction From Baseline
Description	Average back pain was assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicated higher pain. Participants described their average low back pain during the past 24 hours by choosing the appropriate number from 0 to 10. Percentage of reduction from baseline in the daily average LBPI NRS score was calculated as: ([daily value - baseline value] divided by baseline value) multiplied by 100. Number of participants with sustained response rates (for a minimum of 4 consecutive days) in the daily average LBPI NRS scores that were at >=30 percent and >=50 percent reduced from baseline were reported.
Time Frame	Baseline up to Week 4

Outcome Measure Data

Analysis Population Description

FAS included all participants randomized and who had received at least 1 dose of randomized treatment.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
>=30 percent response	25 (1.351) 33.8%	24 (1.091) 32.4%	31 (1.401) 41.9%
>=50 percent response	11 14.9%	9 12.2%	12 16.2%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.97
	Confidence Interval	(2-Sided) 90%; 0.54 to 1.73
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.43
	Confidence Interval	(2-Sided) 90%; 0.81 to 2.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	>=30 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.68
	Confidence Interval	(2-Sided) 90%; 0.39 to 1.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.81
	Confidence Interval	(2-Sided) 90%; 0.37 to 1.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.11
	Confidence Interval	(2-Sided) 90%; 0.53 to 2.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	>=50 percent sustained response rates: Odds Ratios based on a logistic regression model included treatment as a fixed effect and baseline as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 90%; 0.33 to 1.60
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Number of Participants Withdrawn Due to Lack of Efficacy
Description	Participants withdrew from the study due to lack of efficacy (insufficient clinical response) were reported.
Time Frame	Baseline up to Week 4

Outcome Measure Data

Analysis Population Description

FAS included all participants randomized and who had received at least 1 dose of randomized treatment.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
Number [participants]	2 (1.351) 2.7%	0 (1.091) 0%	1 (1.401) 1.4%

12. Secondary Outcome

Title	Time to Withdrawal Due to Lack of Efficacy
Description	Kaplan Meier and Cox Proportional Hazards analyses were to be used to compute the time to withdrawal due to lack of efficacy. Withdrawal due to lack of efficacy was identified from the participant summary case report form (CRF) page and where reason was identified as "Insufficient Clinical Response". Time to withdrawal was calculated as Date of withdrawal - Date of Randomization.
Time Frame	Baseline up to Week 4

Outcome Measure Data

Analysis Population Description

FAS included all participants randomized and who had received at least 1 dose of randomized treatment.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
Median (90% Confidence Interval) [days]	NA (1.351)	NA (1.091)	NA (1.401)

13. Secondary Outcome

Title	Number of Participants Using Rescue Medication
Description	Participants were permitted to use any commercial product (tablet/caplet/capsule) of acetaminophen (paracetamol) 500 mg as a rescue medication. Number of participants who used rescue medication were reported.
Time Frame	Week 1, 2, 3, 4

Outcome Measure Data

Analysis Population Description

FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, "n" signifies participants who were evaluable at the specified time point for each arm.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
Week 1 (n= 74, 74, 74)	34 (1.351) 45.9%	35 (1.091) 47.3%	34 (1.401) 45.9%
Week 2 (n= 67, 72, 72)	26 35.1%	32 43.2%	30 40.5%
Week 3 (n= 63, 69, 71)	25 33.8%	31 41.9%	27 36.5%
Week 4 (59, 66, 67)	23 31.1%	27 36.5%	22 29.7%

14. Secondary Outcome

Title	Number of Days Participants Used the Rescue Medication
Description	The number of days for which the participants used the rescue medication were reported. Participants recorded the usage of acetaminophen rescue medication in the daily diary.
Time Frame	Week 1, 2, 3, 4

Outcome Measure Data

Analysis Population Description

FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, "n" signifies participants who were evaluable at the specified time point for each arm.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
Week 1 (n= 74, 74, 74)	1.7 (2.62)	1.7 (2.49)	1.7 (2.44)
Week 2 (n= 67, 72, 72)	1.6 (2.65)	1.8 (2.77)	1.6 (2.54)
Week 3 (n= 63, 69, 71)	1.9 (3.11)	1.4 (2.22)	1.5 (2.46)
Week 4 (59, 66, 67)	1.4 (2.37)	1.4 (2.15)	1.4 (2.45)

15. Secondary Outcome

Title	Amount of Rescue Medication Used by the Participants
Description	The amount of rescue medication (Acetaminophen [paracetamol]) used was reported. Participants were permitted to use any commercial product of acetaminophen tablet/caplet/capsule.
Time Frame	Week 1, 2, 3, 4

Outcome Measure Data

Analysis Population Description

FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, "n" signifies participants who were evaluable at the specified time point for each arm.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
Week 1 (n= 72, 70, 74)	1388.9 (2703.97)	1621.8 (4169.38)	2064.5 (4298.80)
Week 2 (n= 65, 68, 72)	1030.8 (1669.76)	1594.1 (3708.11)	1920.5 (4327.48)
Week 3 (n= 61, 65, 71)	1172.1 (1955.52)	1416.9 (3552.05)	1740.5 (4361.26)
Week 4 (n= 58, 62, 67)	1101.7 (2069.03)	1348.8 (2925.65)	1489.2 (3567.20)

16. Secondary Outcome

Title	Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 1, 2, and 3
Description	Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.
Time Frame	Baseline, Week 1, 2, 3

Outcome Measure Data

Analysis Population Description

FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, "n" signifies participants who were evaluable at the specified time point for each arm.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
Baseline (n= 74, 74, 74)	9.8 (5.47)	9.4 (5.23)	8.5 (5.48)
Change at week 1 (n= 73, 73, 73)	-0.4 (2.48)	-0.5 (3.73)	-1.2 (3.51)
Change at week 2 (n= 66, 71, 72)	-0.7 (3.17)	-1.3 (3.59)	-1.6 (4.07)
Change at week 3 (n= 62, 67, 71)	-1.0 (3.24)	-1.3 (3.39)	-2.0 (4.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	-0.18
	Confidence Interval	(2-Sided) 90%; -1.06 to 0.70
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.53
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.91
	Confidence Interval	(2-Sided) 90%; -1.80 to -0.03
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.53
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.73
	Confidence Interval	(2-Sided) 90%; -0.15 to 1.61
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.53
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	-0.70
	Confidence Interval	(2-Sided) 90%; -1.69 to 0.29
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.60
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-1.11
	Confidence Interval	(2-Sided) 90%; -2.11 to -0.11
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.60
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.41
	Confidence Interval	(2-Sided) 90%; -0.57 to 1.39
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.59
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	-0.41
	Confidence Interval	(2-Sided) 90%; -1.42 to 0.60
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.61
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-1.27
	Confidence Interval	(2-Sided) 90%; -2.28 to -0.27
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.61
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.86
	Confidence Interval	(2-Sided) 90%; -0.12 to 1.85
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.60
	Estimation Comments

17. Secondary Outcome

Title	Change From Baseline in Roland-Morris Disability Questionnaire (RMDQ) Total Score at Week 4
Description	Each participant assessed his or her own disability due to low back pain using the RMDQ worksheet. The RMDQ total score was calculated as the total number of statements that were checked; the RMDQ total possible scores ranges from 0 to 24, with higher scores indicating greater disability.
Time Frame	Baseline, Week 4

Outcome Measure Data

Analysis Population Description

FAS included all participants randomized and who had received at least 1 dose of randomized treatment.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
Mean (90% Confidence Interval) [units on a scale]	-1.00 (3.36)	-1.64 (3.85)	-2.43 (4.73)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (PF-06372865-Placebo)
	Estimated Value	-0.64
	Confidence Interval	(2-Sided) 90%; -1.63 to 0.35
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Naproxen-Placebo)
	Estimated Value	-1.43
	Confidence Interval	(2-Sided) 90%; -2.40 to -0.45
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 4: An ANCOVA model within an outlier robust Bayesian framework was applied. Baseline was included as a fixed effect. An informative N (-3.28, 1.19^2) prior for the placebo effect was assumed. Non informative prior distributions were assumed for the rest of the model parameters. LOCF was used for missing data.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (PF-06372865-Naproxen)
	Estimated Value	0.79
	Confidence Interval	(2-Sided) 90%; -0.22 to 1.80
	Parameter Dispersion	Type: Value:
	Estimation Comments

18. Secondary Outcome

Title	Change From Baseline in Hopkins Verbal Learning Test-Revised (HVLT-R) at Week 2 and 4
Description	This test assesses verbal learning and memory. Participants are given a list of 12 words and asked to repeat as many words as they can recall during 3 separate learning trials. The total recall score ranges from 0 (no memory) to 36 (best memory) while the delayed recall trial score ranges from 0 (no memory) to 12 (best memory); higher scores indicated greater verbal learning and recall.
Time Frame	Baseline, Week 2, Week 4

Outcome Measure Data

Analysis Population Description

FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, "n" signifies participants who were evaluable at the specified time point for each arm.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
Total recall score: at Baseline (n= 74,74,74)	24.47 (5.118)	22.92 (5.581)	24.46 (5.455)
Total recall score: Change at Week 2 (n= 66,72,71)	0.74 (3.702)	0.57 (3.950)	-0.30 (4.773)
Total recall score: Change at Week 4 (n= 56,66,66)	1.43 (3.637)	0.68 (3.522)	0.11 (4.062)
Delayed Recall Score: at Baseline (n= 74,74,74)	8.59 (2.415)	8.31 (2.828)	8.59 (2.643)
Delayed Recall Score:Change at Week 2 (n=66,72,71)	0.18 (2.225)	-0.57 (2.803)	-0.06 (1.912)
Delayed Recall Score:Change at Week 4 (n=56,65,66)	0.57 (1.925)	-0.28 (2.197)	0.41 (1.831)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	-0.37
	Confidence Interval	(2-Sided) 90%; -1.52 to 0.78
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.70
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.95
	Confidence Interval	(2-Sided) 90%; -2.10 to 0.20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.70
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Total recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.58
	Confidence Interval	(2-Sided) 90%; -0.56 to 1.71
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.68
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	-1.02
	Confidence Interval	(2-Sided) 90%; -2.06 to 0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.63
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-1.21
	Confidence Interval	(2-Sided) 90%; -2.25 to -0.17
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.63
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Total Recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.19
	Confidence Interval	(2-Sided) 90%; -0.82 to 1.19
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.61
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	-0.77
	Confidence Interval	(2-Sided) 90%; -1.39 to -0.15
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.38
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 90%; -0.80 to 0.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.38
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Delayed recall score at Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	-0.60
	Confidence Interval	(2-Sided) 90%; -1.21 to 0.02
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.37
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	-0.85
	Confidence Interval	(2-Sided) 90%; -1.42 to -0.28
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.34
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 90%; -0.67 to 0.46
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.34
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Delayed recall score at Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate. Unplanned readings were excluded from the analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	-0.74
	Confidence Interval	(2-Sided) 90%; -1.29 to -0.20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.33
	Estimation Comments

19. Secondary Outcome

Title	Chronic Low Back Pain (CLBP) Responder Index Analysis
Description	Participants were successful responders if they had any of the following: >=30 percent reduction in mean daily average LBPI from baseline to particular week; decrease of >=30 percent in participant's global assessment of low back pain (disease activity) from baseline to particular week or no worsening (increase) in RMDQ total score from baseline to particular week.
Time Frame	Week 1, 2, 3, 4

Outcome Measure Data

Analysis Population Description

FAS included all participants randomized and who had received at least 1 dose of randomized treatment.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
Week 1	0 (2.62) 0%	0 (2.49) 0%	8 (2.44) 10.8%
Week 2	5 (2.65) 6.8%	8 (2.77) 10.8%	11 (2.54) 14.9%
Week 3	12 (3.11) 16.2%	8 (2.22) 10.8%	14 (2.46) 18.9%
Week 4	9 (2.37) 12.2%	11 (2.15) 14.9%	19 (2.45) 25.7%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.98
	Confidence Interval	(2-Sided) 90%; 0.61 to 1.58
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	2.04
	Confidence Interval	(2-Sided) 90%; 1.33 to 3.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	A repeated measures logistic regression model included treatment and week as fixed effects and LBPI baseline as a covariate. Participant was included as a repeated effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.48
	Confidence Interval	(2-Sided) 90%; 0.31 to 0.74
	Parameter Dispersion	Type: Value:
	Estimation Comments

20. Secondary Outcome

Title	Change From Baseline in Participant's Global Assessment (PtGA) of Low Back Pain Score at Week 1, 2, 3 and 4
Description	Participant rated 5-point Likert scale ranging from 0 (no pain) to 4 (worst possible pain) with a higher score indicating greater level of pain.
Time Frame	Baseline, Week 1, 2, 3, 4

Outcome Measure Data

Analysis Population Description

FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, "n" signifies participants who were evaluable at the specified time point for each arm.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
Change at Week 1 (n= 73, 73, 73)	-0.20	-0.19	-0.34
Change at Week 2 (n= 66, 71, 72)	-0.24	-0.28	-0.39
Change at Week 3 (n= 62, 67, 71)	-0.45	-0.31	-0.43
Change at Week 4 (n= 58, 65, 65)	-0.33	-0.21	-0.54

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	0.01
	Confidence Interval	(2-Sided) 90%; -0.19 to 0.20
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.12
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.14
	Confidence Interval	(2-Sided) 90%; -0.34 to 0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.12
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 90%; -0.05 to 0.35
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.12
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	-0.04
	Confidence Interval	(2-Sided) 90%; -0.26 to 0.18
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.13
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.15
	Confidence Interval	(2-Sided) 90%; -0.37 to 0.07
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.13
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.11
	Confidence Interval	(2-Sided) 90%; -0.10 to 0.33
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.13
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	0.15
	Confidence Interval	(2-Sided) 90%; -0.09 to 0.38
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.14
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 90%; -0.21 to 0.25
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.14
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.13
	Confidence Interval	(2-Sided) 90%; -0.10 to 0.36
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.14
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	0.12
	Confidence Interval	(2-Sided) 90%; -0.13 to 0.38
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.15
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.21
	Confidence Interval	(2-Sided) 90%; -0.46 to 0.05
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.15
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect. Baseline (recordings on Day 1) was included as a covariate.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.33
	Confidence Interval	(2-Sided) 90%; 0.08 to 0.58
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.15
	Estimation Comments

21. Secondary Outcome

Title	Patient Global Impression of Change (PGI-C) Score
Description	PGI-C was a participant rated instrument to measure participant's assessment of change in his or her overall status since the previous visit on a 7-point scale; ranging from 1 (very much improved) to 7 (very much worse), where higher scores indicated more worsening.
Time Frame	Week 1, 2, 3, 4

Outcome Measure Data

Analysis Population Description

FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, "n" signifies participants who were evaluable at the specified time point for each arm.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74	74	74
Week 1 (n= 73, 73, 73)	3.32	3.15	2.95
Week 2 (n= 66, 71, 72)	3.12	3.04	2.83
Week 3 (n= 62, 67, 71)	3.01	2.94	2.63
Week 4 (n= 58, 65, 65)	3.04	2.93	2.61

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	-0.17
	Confidence Interval	(2-Sided) 90%; -0.42 to 0.08
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.15
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.37
	Confidence Interval	(2-Sided) 90%; -0.62 to -0.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.15
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 1: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.20
	Confidence Interval	(2-Sided) 90%; -0.05 to 0.45
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.15
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	-0.08
	Confidence Interval	(2-Sided) 90%; -0.38 to 0.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.18
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.29
	Confidence Interval	(2-Sided) 90%; -0.58 to 0.01
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.18
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 2: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.20
	Confidence Interval	(2-Sided) 90%; -0.09 to 0.49
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.18
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	-0.07
	Confidence Interval	(2-Sided) 90%; -0.36 to 0.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.17
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.38
	Confidence Interval	(2-Sided) 90%; -0.67 to -0.10
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.17
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 3: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.31
	Confidence Interval	(2-Sided) 90%; 0.03 to 0.59
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.17
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (PF-06372865-Placebo)
	Estimated Value	-0.11
	Confidence Interval	(2-Sided) 90%; -0.42 to 0.21
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.19
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference (Naproxen-Placebo)
	Estimated Value	-0.43
	Confidence Interval	(2-Sided) 90%; -0.75 to -0.12
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.19
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Week 4: The mixed effect repeated measures model was used and included treatment, week, baseline, the week * treatment interaction, and the baseline * week interaction as fixed effects and week repeated within each participant as a repeated effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	LS Mean Difference(PF-06372865-Naproxen)
	Estimated Value	0.33
	Confidence Interval	(2-Sided) 90%; 0.02 to 0.63
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.19
	Estimation Comments

22. Secondary Outcome

Title	Number of Participants With Global Evaluation of Study Medication (GESM) at Week 4
Description	Participants rated their study treatment by GESM questionnaire. It was a qualitative measure of efficacy utilizing a 4-point Likert scale ranging from 1 (poor) to 4 (excellent), where higher score indicated a better overall response to the treatment. Number of participants who reported a particular score had been reported.
Time Frame	Week 4

Outcome Measure Data

Analysis Population Description

FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, "number of participants analyzed" signifies those participants who were evaluable for this outcome measure.

Arm/Group Title	Placebo	PF-06372865	Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	70	73	71
Poor	8 (2.62) 10.8%	11 (2.49) 14.9%	5 (2.44) 6.8%
Fair	26 (2.65) 35.1%	18 (2.77) 24.3%	14 (2.54) 18.9%
Good	28 (3.11) 37.8%	36 (2.22) 48.6%	37 (2.46) 50%
Excellent	8 (2.37) 10.8%	8 (2.15) 10.8%	15 (2.45) 20.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, PF-06372865
	Comments	Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.85
	Confidence Interval	(2-Sided) 90%; 0.46 to 1.56
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Naproxen
	Comments	Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	0.43
	Confidence Interval	(2-Sided) 90%; 0.23 to 0.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	PF-06372865, Naproxen
	Comments	Odds Ratios were based on a logistic regression model and included treatment as a fixed effect.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Odds Ratio (OR)
	Estimated Value	1.97
	Confidence Interval	(2-Sided) 90%; 1.06 to 3.65
	Parameter Dispersion	Type: Value:
	Estimation Comments

23. Secondary Outcome

Title	Plasma Concentration of PF-06372865
Description	Data was calculated by setting concentration values below the lower limit of quantification (LLOQ) to zero. The LLOQ was <0.0100 nanogram per milliliter (ng/mL).
Time Frame	Baseline, Week 1, 2, 3, 4

Outcome Measure Data

Analysis Population Description

FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, "n" signifies participants who were evaluable at the specified time point for each arm.

Arm/Group Title	PF-06372865
Arm/Group Description	Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.
Measure Participants	74
Baseline (n= 73)	NA (NA)
Week 1 (n= 74)	15.57 (13.214)
Week 2 (n= 72)	47.51 (45.668)
Week 3 (n= 71)	46.65 (46.305)
Week 4 (n= 65)	48.24 (41.975)

24. Secondary Outcome

Title	Plasma Concentration of Naproxen
Description	Data was calculated by setting concentration values below the LLOQ to zero. The LLOQ was <1000 ng/mL.
Time Frame	Baseline, Week 1, 2, 3, 4

Outcome Measure Data

Analysis Population Description

FAS included all participants randomized and who had received at least 1 dose of randomized treatment. Here, "n" signifies participants who were evaluable at the specified time point for each arm.

Arm/Group Title	Naproxen
Arm/Group Description	Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
Measure Participants	74
Baseline (n= 73)	317.0 (1963.4)
Week 1 (n= 74)	68150 (35213)
Week 2 (n= 72)	67830 (37004)
Week 3 (n= 71)	67140 (38336)
Week 4 (n= 65)	65650 (33419)

Adverse Events

Adverse Event Reporting Description	The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as nonserious in another participant, or one participant may have experienced both a serious and nonserious event during the study.
Arm/Group Title	Placebo		PF-06372865		Naproxen
Arm/Group Description	Participants received placebo matched to PF-06372865 tablets along with Naproxen 500 milligram (mg) tablets orally, twice daily for four weeks.		Participants received PF-06372865 2.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for one week followed by PF-06372865 7.5 mg tablets along with placebo matched to Naproxen tablets orally, twice daily for three weeks.		Participants received Naproxen 500 mg tablets along with placebo matched to PF-06372865 tablets orally, twice daily for four weeks.
All Cause Mortality
	Placebo		PF-06372865		Naproxen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Placebo		PF-06372865		Naproxen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/74 (1.4%)		1/74 (1.4%)		2/74 (2.7%)
Cardiac disorders
Angina pectoris	1/74 (1.4%)		0/74 (0%)		0/74 (0%)
Gastrointestinal disorders
Ileus paralytic	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
General disorders
Chest pain	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
Injury, poisoning and procedural complications
Fall	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
Nervous system disorders
Syncope	1/74 (1.4%)		0/74 (0%)		0/74 (0%)
Transient ischaemic attack	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
Vascular disorders
Hypotension	1/74 (1.4%)		0/74 (0%)		0/74 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		PF-06372865		Naproxen
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	25/74 (33.8%)		34/74 (45.9%)		26/74 (35.1%)
Ear and labyrinth disorders
Vertigo	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Eye disorders
Cataract	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
Eye haemorrhage	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
Gastrointestinal disorders
Abdominal pain upper	1/74 (1.4%)		0/74 (0%)		0/74 (0%)
Constipation	0/74 (0%)		1/74 (1.4%)		2/74 (2.7%)
Diarrhoea	2/74 (2.7%)		1/74 (1.4%)		0/74 (0%)
Dry mouth	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Dyspepsia	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Rectal haemorrhage	1/74 (1.4%)		0/74 (0%)		0/74 (0%)
Vomiting	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Nausea	0/74 (0%)		6/74 (8.1%)		3/74 (4.1%)
General disorders
Asthenia	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Chills	1/74 (1.4%)		0/74 (0%)		0/74 (0%)
Fatigue	2/74 (2.7%)		1/74 (1.4%)		1/74 (1.4%)
Pain	1/74 (1.4%)		0/74 (0%)		0/74 (0%)
Pyrexia	1/74 (1.4%)		0/74 (0%)		0/74 (0%)
Immune system disorders
Seasonal allergy	1/74 (1.4%)		0/74 (0%)		0/74 (0%)
Infections and infestations
Bronchitis	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
Ear infection	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Fungal infection	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Gastroenteritis	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
Nasopharyngitis	1/74 (1.4%)		3/74 (4.1%)		3/74 (4.1%)
Pneumonia	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
Rhinitis	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Sinusitis	1/74 (1.4%)		1/74 (1.4%)		2/74 (2.7%)
Tooth infection	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
Upper respiratory tract infection	1/74 (1.4%)		1/74 (1.4%)		1/74 (1.4%)
Urinary tract infection	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Viral infection	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Injury, poisoning and procedural complications
Fall	1/74 (1.4%)		0/74 (0%)		2/74 (2.7%)
Incision site pain	1/74 (1.4%)		0/74 (0%)		0/74 (0%)
Muscle strain	1/74 (1.4%)		0/74 (0%)		0/74 (0%)
Tooth fracture	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
Investigations
Alanine aminotransferase increased	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Aspartate aminotransferase increased	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Electrocardiogram abnormal	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
Intraocular pressure increased	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Metabolism and nutrition disorders
Diabetes mellitus	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Musculoskeletal and connective tissue disorders
Arthralgia	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
Back pain	1/74 (1.4%)		1/74 (1.4%)		2/74 (2.7%)
Muscle spasms	1/74 (1.4%)		0/74 (0%)		1/74 (1.4%)
Musculoskeletal pain	1/74 (1.4%)		0/74 (0%)		0/74 (0%)
Myalgia	3/74 (4.1%)		1/74 (1.4%)		0/74 (0%)
Neck pain	1/74 (1.4%)		0/74 (0%)		0/74 (0%)
Pain in extremity	1/74 (1.4%)		1/74 (1.4%)		1/74 (1.4%)
Tendonitis	1/74 (1.4%)		0/74 (0%)		0/74 (0%)
Nervous system disorders
Altered state of consciousness	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Balance disorder	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Disturbance in attention	1/74 (1.4%)		1/74 (1.4%)		0/74 (0%)
Dizziness	1/74 (1.4%)		6/74 (8.1%)		0/74 (0%)
Head discomfort	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Headache	5/74 (6.8%)		1/74 (1.4%)		1/74 (1.4%)
Hypersomnia	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Paraesthesia	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Sedation	0/74 (0%)		2/74 (2.7%)		0/74 (0%)
Somnolence	1/74 (1.4%)		9/74 (12.2%)		1/74 (1.4%)
Tinel's sign	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Psychiatric disorders
Abnormal dreams	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
Agitation	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
Anxiety	1/74 (1.4%)		0/74 (0%)		0/74 (0%)
Insomnia	0/74 (0%)		1/74 (1.4%)		1/74 (1.4%)
Panic attack	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Restlessness	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
Renal and urinary disorders
Acute prerenal failure	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Haematuria	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Reproductive system and breast disorders
Breast cyst	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Respiratory, thoracic and mediastinal disorders
Cough	1/74 (1.4%)		0/74 (0%)		1/74 (1.4%)
Nasal congestion	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
Paranasal sinus discomfort	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
Rhinitis allergic	0/74 (0%)		0/74 (0%)		1/74 (1.4%)
Sinus congestion	1/74 (1.4%)		0/74 (0%)		1/74 (1.4%)
Skin and subcutaneous tissue disorders
Dermal cyst	1/74 (1.4%)		0/74 (0%)		0/74 (0%)
Pruritus	1/74 (1.4%)		1/74 (1.4%)		0/74 (0%)
Rash	1/74 (1.4%)		1/74 (1.4%)		2/74 (2.7%)
Rash maculo-papular	0/74 (0%)		1/74 (1.4%)		0/74 (0%)
Rosacea	0/74 (0%)		0/74 (0%)		1/74 (1.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.