Safety And Efficacy Of Tanezumab In Patients With Chronic Pancreatitis

• Sponsor: Pfizer (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01146561
• Collaborator: (none)
• Enrollment: 2
• Locations: 9
• Arms: 2
• Actual Duration (Months): 5.3
• Patients Per Site: 0.2
• Patients Per Site Per Month: 0

Study Details

Study Description

Brief Summary

Tanezumab is effective in reducing the pain associated with chronic pancreatitis.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pancreatitis	Biological: Tanezumab; Other: Placebo	Phase 2

Detailed Description

On 23 Dec 2010 the FDA imposed a clinical halt for anti-NGF compounds due to safety reasons, ie, a case of osteonecrosis which occurred in relation to an anti-NGF compound of another company. All indications with the exception of Cancer Pain are affected resulting in termination of all studies in respective indications. Recruitment of Study A4091044 was stopped effective 27 Dec 2010. Two patients recruited so far did not receive further doses and were followed up for safety until LSLV on 22 Mar 2011.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A PHASE 2, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY OF THE ANALGESIC EFFICACY AND SAFETY OF TANEZUMAB IN PATIENTS WITH CHRONIC PANCREATITIS
• Actual Study Start Date: Oct 13, 2010
• Actual Primary Completion Date: Mar 22, 2011
• Actual Study Completion Date: Mar 22, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Tanezumab 20 mg	Biological: Tanezumab; single administration of tanezumab 20 mg sub-cutaneously
Placebo Comparator: Placebo	Other: Placebo; single administration of placebo to match tanezumab, sub-cutaneously

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Average Chronic Pancreatitis Pain Intensity Score Over the Period From Week 1 to Week 8 [Baseline, Week 1 to 8]

   Daily average chronic pancreatitis pain is assessed with an 11-point Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).

Secondary Outcome Measures

1. Change From Baseline in Average and Worst Chronic Pancreatitis Pain Intensity Score at Week 1, 2, 4, 6, 8, 12 and 16 [Baseline, Week 1, 2, 4, 6, 8, 12, 16]

   Daily average chronic pancreatitis pain and worst chronic pancreatitis pain are assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).

2. Change From Baseline in Worst Chronic Pancreatitis Pain Intensity Score Over Week 1 to Week 8 Period [Baseline, Week 1 to 8]

   Daily average worst chronic pancreatitis pain is assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).

3. Number of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average and Worst Chronic Pancreatitis Pain Intensity Score [Week 8]

   Daily average chronic pancreatitis pain and worst chronic pancreatitis pain are assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).

4. Number of Participants With Cumulative Reduction From Baseline in Average and Chronic Pancreatitis Pain Intensity Score [Week 8]

   Daily average chronic pancreatitis pain and worst chronic pancreatitis pain are assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).

5. Change From Baseline in Brief Pain Inventory - Short Form (BPI-sf) Average and Worst Pain Score at Week 8 and 16 [Baseline, Week 8, 16]

   BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (question 5 consists of 7 items that assess level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure were scored by item, with lower scores indicated less pain or pain interference.

6. Change From Baseline in Brief Pain Inventory - Short Form (BPI-sf) Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and 16 [Baseline, Week 8, 16]

   BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and question 5 consisted of 7 items that assess level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure was scored by item, with lower score indicated less pain or pain interference. The 7 items in question 5 were averaged to obtain pain interference index, range: 0 to 10; higher score=greater impairment.

7. Change From Baseline in Patient's Global Assessment (PGA) of Chronic Pancreatitis at Week 4, 8 and 16 [Baseline, Week 4, 8, 12]

   Patient's Global Assessment of Chronic Pancreatitis is a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor) for the following question: "Considering all the ways your chronic pancreatitis affects you, how are you doing today?".

8. Number of Participants With Improvement of Greater Than or Equal to 2 Points From Baseline in Patient's Global Assessment (PGA) of Chronic Pancreatitis [Weeks 4, 8, 16]

   Patient's Global Assessment of Chronic Pancreatitis is a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor) for the following question: "Considering all the ways your chronic pancreatitis affects you, how are you doing today?".

9. Number of Participants With Anti Drug Antibody [Baseline, Week 8, 16]

10. Neuropathy Impairment Score (NIS) [Baseline and Weeks 2, 4, 8, 16]

    NIS: 74-item questionnaire assesses muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.

11. Number of Participants With Injection Site Reaction [Day 1 up to Week 16]

    Assessment of the injection site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).

12. Plasma Tanezumab Levels [Baseline (pre-dose), Week 2, 4, 8, 16]

13. Serum Nerve Growth Factor (NGF) Levels [Baseline (pre-dose), Week 8, 16]

14. Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) [Baseline up to 112 days after the dose of study medication (up to 113 days)]

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An 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; persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state.

15. Number of Participants With Clinically Significant Laboratory Abnormalities [Baseline up to Week 16]

    Laboratory analysis included blood chemistry, hematology, urinalysis, pregnancy test, glycosylated hemoglobin levels (HbA1c levels) test and blood alcohol test.

16. Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities [Baseline up to Week 16]

    All standard intervals (PR, QRS, QT, QT interval corrected for heart rate using Fridericia's formula [QTcF], QT interval corrected for heart rate using Bazett's formula [QTcB], RR intervals and heart rate) were analyzed for ECG abnormalities.

Other Outcome Measures

1. Number of Participants With Subcutaneous Doses [Day 1]

   Number of participants who received the single dose of placebo are reported.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Adult male or female

• Written informed consent

• Diagnosis of chronic pancreatitis based on imaging studies

• Persistent abdominal pain due to chronic pancreatitis

• Qualifying pain score during the pre-treatment period

• Willing to comply with study visit schedule and study requirements including for women of child-bearing potential or male patients with female partners of child-bearing potential, the use of 2 forms of birth control

Exclusion Criteria:

• Pregnant women, lactating mothers, women suspected of being pregnant and women who wish to become pregnant during the course of the study

• Chronic pancreatitis as a complication of pancreatic cancer or acute pancreatic duct obstruction

• Pancreatic surgery, lithotripsy or endoscopist decompression within 3 months

• History of alcoholism (within 1 year of screening) or concurrent alcohol abuse

• History of cancer in the past years

• Significant cardiac disease within 6 months

• History, diagnosis or signs and symptoms of significant neurologic disease

• Disqualifying laboratory values including Hepatitis B or C, HIV and drug test

• Other medical condition that may interfere with study endpoints or safety of the patient as determined by the Investigator

• Known history of rheumatoid arthritis

• Avascular necrosis of the bone

• History of trauma to a major joint Evidence of osteoarthritis

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gastroenterology Group-of Naples	Naples	Florida	United States	34102-5449
2	Palm Beach Gastroenterology	Wellington	Florida	United States	33414
3	Digestive Health Specialists	Tupelo	Mississippi	United States	38801
4	North Mississippi Medical Center	Tupelo	Mississippi	United States	38801
5	Carolinas Digestive Health Associates	Harrisburg	North Carolina	United States	28075
6	Carolinas Digestive Health Associates	Harrisburg	North Carolina	United States	28705
7	UMPC Division of Radiology	Pittsburgh	Pennsylvania	United States	15213
8	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania	United States	15213
9	Wisconsin Center for Advanced Research	Milwaukee	Wisconsin	United States	53215

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: NCT01146561
• Other Study ID Numbers: A4091044; 2010-019012-21; CHRONIC PANCREATITIS POC STUDY
• First Posted: Jun 17, 2010
• Last Update Posted: Mar 23, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Pancreatitis; Pancreatitis, Chronic; Tanezumab

Study Results

Participant Flow

Pre-assignment Detail	Due to the United States Food and Drug Administration (FDA) clinical hold, the study was prematurely terminated and no participants were enrolled in planned reporting arm tanezumab 20 milligram (mg) treatment and hence tanezumab 20 mg could not be administrated.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Period Title: Overall Study
STARTED	2
COMPLETED	0
NOT COMPLETED	2

Baseline Characteristics

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Overall Participants	2
Age, Customized (Count of Participants)
18 to 44 years	1 50%
45 to 64 years	1 50%
Sex: Female, Male (Count of Participants)
Female	2 100%
Male	0 0%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Average Chronic Pancreatitis Pain Intensity Score Over the Period From Week 1 to Week 8
Description	Daily average chronic pancreatitis pain is assessed with an 11-point Numeric Rating Scale (NRS) ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame	Baseline, Week 1 to 8

Outcome Measure Data

Analysis Population Description

No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Measure Participants	0

2. Secondary Outcome

Title	Change From Baseline in Average and Worst Chronic Pancreatitis Pain Intensity Score at Week 1, 2, 4, 6, 8, 12 and 16
Description	Daily average chronic pancreatitis pain and worst chronic pancreatitis pain are assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame	Baseline, Week 1, 2, 4, 6, 8, 12, 16

Outcome Measure Data

Analysis Population Description

No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Measure Participants	0

3. Secondary Outcome

Title	Change From Baseline in Worst Chronic Pancreatitis Pain Intensity Score Over Week 1 to Week 8 Period
Description	Daily average worst chronic pancreatitis pain is assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame	Baseline, Week 1 to 8

Outcome Measure Data

Analysis Population Description

No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Measure Participants	0

4. Secondary Outcome

Title	Number of Participants With At Least 30 Percent (%), 50%, 70% and 90% Reduction From Baseline in Average and Worst Chronic Pancreatitis Pain Intensity Score
Description	Daily average chronic pancreatitis pain and worst chronic pancreatitis pain are assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Measure Participants	0

5. Secondary Outcome

Title	Number of Participants With Cumulative Reduction From Baseline in Average and Chronic Pancreatitis Pain Intensity Score
Description	Daily average chronic pancreatitis pain and worst chronic pancreatitis pain are assessed with an 11-point NRS ranging from 0 (no pain) to 10 (worst possible pain).
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Measure Participants	0

6. Secondary Outcome

Title	Change From Baseline in Brief Pain Inventory - Short Form (BPI-sf) Average and Worst Pain Score at Week 8 and 16
Description	BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (question 5 consists of 7 items that assess level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure were scored by item, with lower scores indicated less pain or pain interference.
Time Frame	Baseline, Week 8, 16

Outcome Measure Data

Analysis Population Description

No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Measure Participants	0

7. Secondary Outcome

Title	Change From Baseline in Brief Pain Inventory - Short Form (BPI-sf) Pain Interference Index and Pain Interference Score for General Activity, Walking Ability, Sleep and Normal Work at Week 8 and 16
Description	BPI-sf is an 11-item self-report questionnaire that is designed to assess the severity and impact of pain on daily functions. BPI-sf are 4 questions that assess pain intensity (worst, least, average, right now) and question 5 consisted of 7 items that assess level of interference of pain on daily functions (general activity, mood, walking ability, normal work, relations with other people, sleep, enjoyment of life). Each item was answered on a scale ranging from 0 to 10; '0=No pain and 10=Pain as bad as you can imagine'. Measure was scored by item, with lower score indicated less pain or pain interference. The 7 items in question 5 were averaged to obtain pain interference index, range: 0 to 10; higher score=greater impairment.
Time Frame	Baseline, Week 8, 16

Outcome Measure Data

Analysis Population Description

No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Measure Participants	0

8. Secondary Outcome

Title	Change From Baseline in Patient's Global Assessment (PGA) of Chronic Pancreatitis at Week 4, 8 and 16
Description	Patient's Global Assessment of Chronic Pancreatitis is a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor) for the following question: "Considering all the ways your chronic pancreatitis affects you, how are you doing today?".
Time Frame	Baseline, Week 4, 8, 12

Outcome Measure Data

Analysis Population Description

No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Measure Participants	0

9. Secondary Outcome

Title	Number of Participants With Improvement of Greater Than or Equal to 2 Points From Baseline in Patient's Global Assessment (PGA) of Chronic Pancreatitis
Description	Patient's Global Assessment of Chronic Pancreatitis is a global evaluation that utilizes a 5-point Likert scale with a score of 1 being the best (Very Good) and a score of 5 being the worst (Very Poor) for the following question: "Considering all the ways your chronic pancreatitis affects you, how are you doing today?".
Time Frame	Weeks 4, 8, 16

Outcome Measure Data

Analysis Population Description

No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Measure Participants	0

10. Secondary Outcome

Title	Number of Participants With Anti Drug Antibody
Time Frame	Baseline, Week 8, 16

Outcome Measure Data

Analysis Population Description

No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Measure Participants	0

11. Secondary Outcome

Title	Neuropathy Impairment Score (NIS)
Description	NIS: 74-item questionnaire assesses muscle weakness, reflexes and sensation; scored separately for left, right limbs (37 items for each side). Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae) and sensation (touch pressure, pin-prick, vibration, joint position) scored 0 = normal, 1= decreased, or 2 = absent. Total possible NIS score range 0-244, higher score=greater impairment.
Time Frame	Baseline and Weeks 2, 4, 8, 16

Outcome Measure Data

Analysis Population Description

No efficacy analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Measure Participants	0

12. Secondary Outcome

Title	Number of Participants With Injection Site Reaction
Description	Assessment of the injection site reactions were based on presence of erythema (redness), induration (swelling), ecchymosis (bruising), pruritus (itching) and pain that occurred after the injection had been administered (not related to pain of needle insertion).
Time Frame	Day 1 up to Week 16

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT) analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Measure Participants	2
Count of Participants [Participants]	1 50%

13. Secondary Outcome

Title	Plasma Tanezumab Levels
Time Frame	Baseline (pre-dose), Week 2, 4, 8, 16

Outcome Measure Data

Analysis Population Description

No pharmacokinetic analysis were performed as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Measure Participants	0

14. Secondary Outcome

Title	Serum Nerve Growth Factor (NGF) Levels
Time Frame	Baseline (pre-dose), Week 8, 16

Outcome Measure Data

Analysis Population Description

No analysis was performed for this outcome measure as no tanezumab participant and only two placebo participants were randomized due to early study discontinuation of FDA clinical hold.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Measure Participants	0

15. Secondary 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 drug without regard to possibility of causal relationship. An 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; persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 112 days after last dose that were absent before treatment or that worsened relative to pretreatment state.
Time Frame	Baseline up to 112 days after the dose of study medication (up to 113 days)

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Measure Participants	2
AEs	2 100%
SAEs	0 0%

16. Secondary Outcome

Title	Number of Participants With Clinically Significant Laboratory Abnormalities
Description	Laboratory analysis included blood chemistry, hematology, urinalysis, pregnancy test, glycosylated hemoglobin levels (HbA1c levels) test and blood alcohol test.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Measure Participants	2
Count of Participants [Participants]	0 0%

17. Secondary Outcome

Title	Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Description	All standard intervals (PR, QRS, QT, QT interval corrected for heart rate using Fridericia's formula [QTcF], QT interval corrected for heart rate using Bazett's formula [QTcB], RR intervals and heart rate) were analyzed for ECG abnormalities.
Time Frame	Baseline up to Week 16

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Measure Participants	2
Count of Participants [Participants]	0 0%

18. Other Pre-specified Outcome

Title	Number of Participants With Subcutaneous Doses
Description	Number of participants who received the single dose of placebo are reported.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

ITT analysis set included all randomized participants who received at least 1 dose of subcutaneous study medication.

Arm/Group Title	Placebo
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
Measure Participants	2
Count of Participants [Participants]	2 100%

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
Arm/Group Description	A single dose of placebo matched to tanezumab 20 milligram (mg) injection subcutaneously on Day 1.
All Cause Mortality
	Placebo
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Placebo
	Affected / at Risk (%)	# Events
Total	0/2 (0%)
Other (Not Including Serious) Adverse Events
	Placebo
	Affected / at Risk (%)	# Events
Total	2/2 (100%)
General disorders
Injection site reaction	1/2 (50%)
Pain	1/2 (50%)
Infections and infestations
Nasopharyngitis	1/2 (50%)
Nervous system disorders
Dizziness	1/2 (50%)

Limitations/Caveats

Due to FDA clinical hold, the study was prematurely terminated with only 2 participants were enrolled and randomized to placebo treatment and hence, efficacy and pharmacokinetic analysis was not performed.

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.