An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain
Sponsor
Janssen Pharmaceutical K.K. (Industry)
Overall Status
Completed
CT.gov ID
NCT00736853
Collaborator
(none)
321
22
3
7
14.6
2.1
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of tramadol hydrochloride plus acetaminophen (JNS013) in participants with chronic pain accompanied by osteoarthritis (a progressive and degenerative joint disease, in which the joints become painful and stiff) of the knee or low back pain (acute or chronic pain in the lumbar or sacral regions) which cannot be controlled sufficiently with non-steriodal anti-inflammatory drugs (NSAIDs).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
This is a multi-center (when more than one hospital or medical school team work on a medical research study), double-blind (test or experiment in which neither the person giving the treatment nor the participant knows which treatment the participant is receiving), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel group comparison study. The total duration of the study will be 11 weeks and consists of 4 periods; a pre-observation period (4 weeks), open-label period (2 weeks), double-blind period (4 weeks) and follow-up period (1 week). Participants will receive tramadol hydrochloride plus acetaminophen tablets orally 4 times daily for 2 weeks with no less than 4-hour intervals (up to 8 tablets per day) during the open-label period and the dose will be fixed for each participant in the latter 1 week. During the double-period participants will receive tramadol hydrochloride plus acetaminophen tablets or placebo at the same dose as used for the latter 1 week of the open-label period for up to 4 weeks. Efficacy will be primarily evaluated by number of participants with insufficient pain relief after the start of double-blind period. Participant's safety will be monitored throughout the study.
Study Design
Study Type:
Interventional
Actual Enrollment
:
321 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 3 Study of JNS013 in Patients With Chronic Pain
Study Start Date
:
Jun 1, 2008
Actual Primary Completion Date
:
Jan 1, 2009
Actual Study Completion Date
:
Jan 1, 2009
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Tramadol Hydrochloride Plus Acetaminophen (Open-Label)
|
Drug: Tramadol Hydrochloride Plus Acetaminophen (Open-Label)
Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily will be given for one week; dose level will be fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose will be 8 tablets).
|
| Experimental: Tramadol Hydrochloride Plus Acetaminophen (Double Blind)
|
Drug: Tramadol Hydrochloride Plus Acetaminophen (Double-Blind)
Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) will be given 4 times daily up to 4 weeks.
|
| Placebo Comparator: Placebo (Double-Blind)
|
Drug: Placebo (Double-Blind)
Matching placebo will be given up to 4 weeks.
|
Outcome Measures
Primary Outcome Measures
- Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period [Day 28 of double-blind period]
The pain relief was regarded as insufficient, if either of the following was met, a) the value of average pain intensity felt in daily living during the past 24 hours (Visual analog scale 24 [VAS24] ) on 2 consecutive days in double-blind period worsened greater than 15 millimeter (mm) compared with the average VAS24 during 3 days before the end of open-label period, b) when the participant asked for discontinuation of treatment with the study drug because of insufficient pain relief.
Secondary Outcome Measures
- Change in the Visual Analog Scale for the Last 24 Hours (VAS24) Value at the Start of the Double-Blind Period From the Baseline Value at the Start of the Open-Label Period [Day 1 of open-label period and Day 1 of double-blind period]
Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement.
- Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period [Day 1 and Day 28 of double-blind period]
Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement.
- Mean Pain Intensity (PI) Score During Open-Label Period [Pre-dose and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period]
PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain.
- Mean PI Score During Double-Blind Period [Pre-dose and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period]
The PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain.
- Mean Pain Intensity Difference (PID) During the Open-Label Period [Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period]
The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.
- Mean PID During the Double-Blind Period [Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period]
The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.
- Mean Pain Relief (PAR) Score During the Open-Label Period [2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period]
PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.
- Mean PAR Score During the Double-Blind Period [2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period]
PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.
- Pain Intensity Difference and Pain Relief Scores (PRID) During the Open-Label Period [2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period]
The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score ranges for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief.
- Pain Intensity Difference and Pain Relief Scores (PRID) During the Double-Blind Period [2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period]
The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score range for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief.
- Sum of Pain Intensity Difference (SPID) Score During the Open-Label Period [Day 1, and Day 8 of open-label period]
The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.
- Sum of Pain Intensity Difference (SPID) Score During the Double-Blind Period [Day 1, 8, 15, 22 and 28 of double-blind period]
The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best.
- Total Pain Relief (TOTPAR) Score During the Open-Label Period [Day 1 and Day 8 of open-label period]
The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief.
- Total Pain Relief (TOTPAR) Score During the Double-Blind Period [Day 1, 8, 15, 22 and 28 of double-blind period]
The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief.
- Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Open-Label Period [Day 1, and Day 8 of open-label period]
The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0=no relief to 4=complete relief.
- Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Double-Blind Period [Day 1, 8, 15, 22 and 28 of double-blind period]
The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief.
- Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Total Score at Day 14 of Open-Label Period [Day 1 and Day 14 of open-label period]
The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability.
- Change From Baseline in RDQ Total Score at Day 28 of Double-Blind Period [Day 1 and Day 28 of double-blind period]
The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability.
- Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire Score at Day 14 of Open-Label Period [Day 1 and Day 14 of open-label period]
The WOMAC questionnaire is an activity of daily living (ADL) indicator for Knee Osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL.
- Change From Baseline in WOMAC Questionnaire Score at Day 28 of Double-Blind Period [Day 1 and Day 28 of double-blind period]
The WOMAC questionnaire is an activity of daily living (ADL) indicator for knee osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL.
- Change From Baseline in Short Form-36 (SF-36) Score at Day 14 of Open-Label Period [Day 1 and Day 14 of open-label period]
The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status.
- Change From Baseline in SF-36 at Day 28 of Double-Blind Period [Day 1 and Day 28 of double-blind period]
The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status.
Eligibility Criteria
Criteria
Ages Eligible for Study:
20 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Participants with sustention of chronic pain associated with OA or LBP for at least 3 months
-
Participants whose pain cannot be controlled sufficiently with at least 14-day continuous treatment with identical oral NSAIDs at a usual maximum dose during 3 months prior to this study
-
Outpatients
-
Ambulatory participants without need for any supportive device or assistance during daily life
Exclusion Criteria:
-
Participants with conditions for which opioids are contraindicated
-
Participants with conditions for which acetaminophen is contraindicated
-
Participants with history of convulsion or the possibility of convulsive seizure
-
Participants with concurrent, previous, or possible alcohol dependence, drug dependence, or narcotic addiction
-
Pregnant participants or those who may be pregnant, lactating mothers, and participants who wish pregnancy during the study period
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Aichi | Japan | |||
| 2 | Amagasaki | Japan | |||
| 3 | Chiba N/A | Japan | |||
| 4 | Chiba | Japan | |||
| 5 | Edogawa | Japan | |||
| 6 | Fukuoka | Japan | |||
| 7 | Fukushima | Japan | |||
| 8 | Iruma | Japan | |||
| 9 | Kagoshima | Japan | |||
| 10 | Kawasaki | Japan | |||
| 11 | Kumagaya | Japan | |||
| 12 | Kurume | Japan | |||
| 13 | Meguro | Japan | |||
| 14 | Minato | Japan | |||
| 15 | Niigata N/A | Japan | |||
| 16 | Niigata | Japan | |||
| 17 | Ohta-Ku | Japan | |||
| 18 | Okazaki | Japan | |||
| 19 | Sagamihara | Japan | |||
| 20 | Setagaya | Japan | |||
| 21 | Shibuya | Japan | |||
| 22 | Shinjuku-Ku | Japan |
Sponsors and Collaborators
- Janssen Pharmaceutical K.K.
Investigators
- Study Director: Janssen Pharmaceutical K.K. Clinical Trial, Janssen Pharmaceutical K.K.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT00736853
Other Study ID Numbers:
- CR015112
- JNS013-JPN-04
First Posted:
Aug 18, 2008
Last Update Posted:
Sep 26, 2013
Last Verified:
Jul 1, 2013
Keywords provided by Janssen Pharmaceutical K.K.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Open-Label) | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets). | Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks. | Matching placebo was given up to 4 weeks. |
| Period Title: Open-Label Period | |||
| STARTED | 319 | 0 | 0 |
| Treated | 277 | 0 | 0 |
| COMPLETED | 187 | 0 | 0 |
| NOT COMPLETED | 132 | 0 | 0 |
| Period Title: Open-Label Period | |||
| STARTED | 0 | 94 | 93 |
| COMPLETED | 0 | 70 | 45 |
| NOT COMPLETED | 0 | 24 | 48 |
Baseline Characteristics
| Arm/Group Title | Entire Study Population |
|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets) during the open-label period. Participants received placebo or fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg (same dose which was used in second week of open-label period) in double-blind period. |
| Overall Participants | 277 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
57.0
(17.5)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
168
60.6%
|
| Male |
109
39.4%
|
Outcome Measures
| Title | Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period |
|---|---|
| Description | The pain relief was regarded as insufficient, if either of the following was met, a) the value of average pain intensity felt in daily living during the past 24 hours (Visual analog scale 24 [VAS24] ) on 2 consecutive days in double-blind period worsened greater than 15 millimeter (mm) compared with the average VAS24 during 3 days before the end of open-label period, b) when the participant asked for discontinuation of treatment with the study drug because of insufficient pain relief. |
| Time Frame | Day 28 of double-blind period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included participants who received at least one dose of the study drug. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks. | Matching placebo was given up to 4 weeks. |
| Measure Participants | 94 | 93 |
| Number [number of participants] |
20
7.2%
|
43
NaN
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Tramadol Hydrochloride and Acetaminophen (Double-Blind), Placebo (Double-Blind) |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Superiority or Other | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.0001 |
| Comments | ||
| Method | Log Rank | |
| Comments | Stratified Log-rank test with the target disease as the stratification factor | |
| Method of Estimation | Estimation Parameter | Hazard Ratio (HR) |
| Estimated Value | 0.377 | |
| Confidence Interval |
(2-Sided) 95% 0.221 to 0.641 |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
| Title | Change in the Visual Analog Scale for the Last 24 Hours (VAS24) Value at the Start of the Double-Blind Period From the Baseline Value at the Start of the Open-Label Period |
|---|---|
| Description | Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement. |
| Time Frame | Day 1 of open-label period and Day 1 of double-blind period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included participants who received at least one dose of study drug. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets). |
| Measure Participants | 277 |
| Day 1 of open-label period |
66.27
(13.69)
|
| Change at Day 1 of double-blind period |
-28.17
(21.16)
|
| Title | Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period |
|---|---|
| Description | Pain over the last 24 hours was assessed by using VAS score ranges from 0 mm=no pain to 100 mm=worst possible pain. An increase in score from Baseline represented disease progression and decrease represented improvement. |
| Time Frame | Day 1 and Day 28 of double-blind period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included participants who received at least one dose of the study drug. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks. | Matching placebo was given up to 4 weeks. |
| Measure Participants | 94 | 93 |
| Day 1 |
30.33
(17.47)
|
31.18
(16.59)
|
| Change at Day 28 |
-0.67
(18.14)
|
6.21
(22.50)
|
| Title | Mean Pain Intensity (PI) Score During Open-Label Period |
|---|---|
| Description | PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain. |
| Time Frame | Pre-dose and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets). |
| Measure Participants | 277 |
| Day 1; Pre-dose (n=275) |
1.7
(0.56)
|
| Day 1; 2 hours after dosing (n=274) |
1.2
(0.62)
|
| Day 1; 4 hours after dosing (n=274) |
1.1
(0.65)
|
| Day 8; Pre-dose (n=219) |
1.2
(0.43)
|
| Day 8; 2 hours after dosing (n=219) |
1.0
(0.49)
|
| Day 8; 4 hours after dosing (n=219) |
0.9
(0.55)
|
| Title | Mean PI Score During Double-Blind Period |
|---|---|
| Description | The PI was evaluated on a 4-stage scale with a score ranging from 0 to 3, wherein 0=no pain and 3=severe pain. |
| Time Frame | Pre-dose and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included participants who received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks. | Matching placebo was given up to 4 weeks. |
| Measure Participants | 94 | 93 |
| Day 1; Pre-dose (n=84, 89) |
1.2
(0.37)
|
1.2
(0.37)
|
| Day 1; 2 hours after dosing (n=84, 89) |
1.0
(0.44)
|
1.1
(0.43)
|
| Day 1; 4 hours after dosing (n=84, 89) |
1.0
(0.49)
|
1.1
(0.47)
|
| Day 8; Pre-dose (n=74, 48) |
1.2
(0.39)
|
1.2
(0.42)
|
| Day 8; 2 hours after dosing (n=74, 48) |
1.0
(0.47)
|
1.1
(0.58)
|
| Day 8; 4 hours after dosing (n=74, 48) |
0.9
(0.51)
|
1.1
(0.43)
|
| Day 15; Pre-dose (n=67, 41) |
1.1
(0.33)
|
1.1
(0.33)
|
| Day 15; 2 hours after dosing (n=67, 41) |
1.0
(0.46)
|
1.0
(0.50)
|
| Day 15; 4 hours after dosing (n=67, 41) |
0.8
(0.51)
|
0.9
(0.52)
|
| Day 22; Pre-dose (n=63, 40) |
1.1
(0.30)
|
1.2
(0.38)
|
| Day 22, 2 hours after dosing (n=63, 40) |
1.0
(0.42)
|
1.0
(0.50)
|
| Day 22; 4 hours after dosing (n=63, 40) |
0.9
(0.49)
|
1.0
(0.50)
|
| Day 28; Pre-dose (n=72, 47) |
1.1
(0.33)
|
1.2
(0.41)
|
| Day 28; 2 hours after dosing (n=72, 47) |
1.0
(0.44)
|
1.0
(0.51)
|
| Day 28; 4 hours after dosing (n=72, 47) |
0.9
(0.50)
|
1.0
(0.49)
|
| Title | Mean Pain Intensity Difference (PID) During the Open-Label Period |
|---|---|
| Description | The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best. |
| Time Frame | Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, and Day 8 of open-label period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets). |
| Measure Participants | 277 |
| Day 1; 2 hours after dosing (n=274) |
0.4
(0.59)
|
| Day 1; 4 hours after dosing (n=274) |
0.5
(0.66)
|
| Day 8; 2 hours after dosing (n=219) |
0.2
(0.50)
|
| Day 8; 4 hours after dosing (n=219) |
0.3
(0.52)
|
| Title | Mean PID During the Double-Blind Period |
|---|---|
| Description | The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best. |
| Time Frame | Pre-dose, and post-dose at 2 hours, 4 hours on Day 1, 8, 15, 22 and 28 of double-blind period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks. | Matching placebo was given up to 4 weeks. |
| Measure Participants | 94 | 93 |
| Day 1; 2 hours after dosing (n=84, 89) |
0.2
(0.40)
|
0.1
(0.34)
|
| Day 1; 4 hours after dosing (n=84, 89) |
0.2
(0.49)
|
0.1
(0.42)
|
| Day 8; 2 hours after dosing (n=74, 48) |
0.2
(0.39)
|
0.1
(0.46)
|
| Day 8; 4 hours after dosing (n=74, 48) |
0.3
(0.50)
|
0.2
(0.38)
|
| Day 15; 2 hours after dosing (n=67, 41) |
0.1
(0.36)
|
0.2
(0.44)
|
| Day 15; 4 hours after dosing (n=67, 41) |
0.3
(0.49)
|
0.2
(0.51)
|
| Day 22; 2 hours after dosing (n=63, 40) |
0.1
(0.35)
|
0.2
(0.42)
|
| Day 22; 4 hours after dosing (n=63, 40) |
0.2
(0.42)
|
0.2
(0.42)
|
| Day 28; 2 hours after dosing (n=72, 47) |
0.2
(0.36)
|
0.2
(0.41)
|
| Day 28; 4 hours after dosing (n=72, 47) |
0.3
(0.44)
|
0.2
(0.43)
|
| Title | Mean Pain Relief (PAR) Score During the Open-Label Period |
|---|---|
| Description | PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief. |
| Time Frame | 2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included participants who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets). |
| Measure Participants | 277 |
| Day 1; 2 hours after dosing (n=274) |
1.2
(0.97)
|
| Day 1; 4 hours after dosing (n=274) |
1.4
(1.01)
|
| Day 8; 2 hours after dosing (n=219) |
1.7
(1.03)
|
| Day 8; 4 hours after dosing (n=219) |
1.8
(1.02)
|
| Title | Mean PAR Score During the Double-Blind Period |
|---|---|
| Description | PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief. |
| Time Frame | 2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks. | Matching placebo was given up to 4 weeks. |
| Measure Participants | 94 | 93 |
| Day 1; 2 hours after dosing (n=84, 89) |
1.7
(1.02)
|
1.1
(1.04)
|
| Day 1; 4 hours after dosing (n=84, 89) |
1.8
(1.01)
|
1.2
(1.00)
|
| Day 8; 2 hours after dosing (n=74, 48) |
1.9
(1.06)
|
1.2
(1.08)
|
| Day 8; 4 hours after dosing (n=74, 48) |
1.9
(1.01)
|
1.4
(1.05)
|
| Day 15; 2 hours after dosing (n=67, 41) |
2.1
(1.09)
|
1.7
(1.11)
|
| Day 15; 4 hours after dosing (n=67, 41) |
2.1
(1.00)
|
1.7
(1.06)
|
| Day 22; 2 hours after dosing (n=63, 40) |
2.1
(0.96)
|
1.8
(1.21)
|
| Day 22; 4 hours after dosing (n=63, 40) |
2.2
(1.00)
|
1.8
(1.26)
|
| Day 28; 2 hours after dosing (n=72, 47) |
2.1
(1.00)
|
1.6
(1.26)
|
| Day 28; 4 hours after dosing (n=72, 47) |
2.1
(1.04)
|
1.7
(1.29)
|
| Title | Pain Intensity Difference and Pain Relief Scores (PRID) During the Open-Label Period |
|---|---|
| Description | The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score ranges for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief. |
| Time Frame | 2 hours, 4 hours post-dose on Day 1, and Day 8 of open-label period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included who received at least one dose of study medication. Here 'n' signifies number of participants evaluable for each time point. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets). |
| Measure Participants | 277 |
| Day 1; 2 hours after dosing (n=274) |
1.6
(1.39)
|
| Day 1; 4 hours after dosing (n=274) |
1.9
(1.49)
|
| Day 8; 2 hours after dosing (n=219) |
1.9
(1.30)
|
| Day 8; 4 hours after dosing (n=219) |
2.2
(1.36)
|
| Title | Pain Intensity Difference and Pain Relief Scores (PRID) During the Double-Blind Period |
|---|---|
| Description | The PRID is defined as sum of PID and PAR Scores for each participant at each evaluation time point (at 2 and 4 hours after the dosing). The overall possible score range for PRID is -2=worst to 7=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on a 5-stage scale score ranges from 0=no relief and 4=complete relief. |
| Time Frame | 2 hours, 4 hours post-dose on Day 1, 8, 15, 22 and 28 of double-blind period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks. | Matching placebo was given up to 4 weeks. |
| Measure Participants | 94 | 93 |
| Day 1; 2 hours after dosing (n=84, 89) |
1.9
(1.20)
|
1.2
(1.19)
|
| Day 1; 4 hours after dosing (n=84, 89) |
2.0
(1.28)
|
1.2
(1.18)
|
| Day 8; 2 hours after dosing (n=74, 48) |
2.1
(1.23)
|
1.4
(1.36)
|
| Day 8; 4 hours after dosing (n=74, 48) |
2.3
(1.22)
|
1.6
(1.25)
|
| Day 15; 2 hours after dosing (n=67, 41) |
2.2
(1.29)
|
1.8
(1.39)
|
| Day 15; 4 hours after dosing (n=67, 41) |
2.4
(1.27)
|
1.9
(1.35)
|
| Day 22; 2 hours after dosing (n=63, 40) |
2.3
(1.10)
|
2.0
(1.46)
|
| Day 22; 4 hours after dosing (n=63, 40) |
2.4
(1.24)
|
2.1
(1.45)
|
| Day 28; 2 hours after dosing (n=72, 47) |
2.2
(1.14)
|
1.8
(1.52)
|
| Day 28; 4 hours after dosing (n=72, 47) |
2.4
(1.28)
|
1.9
(1.49)
|
| Title | Sum of Pain Intensity Difference (SPID) Score During the Open-Label Period |
|---|---|
| Description | The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best. |
| Time Frame | Day 1, and Day 8 of open-label period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets). |
| Measure Participants | 277 |
| Day 1 (n=274) |
0.9
(1.17)
|
| Day 8 (n=219) |
0.5
(0.93)
|
| Title | Sum of Pain Intensity Difference (SPID) Score During the Double-Blind Period |
|---|---|
| Description | The SPID is defined as sum of the PID at 2 and 4 hours after dosing on each evaluation day. The overall possible score ranges for SPID is -4=worst to 6=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best. |
| Time Frame | Day 1, 8, 15, 22 and 28 of double-blind period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks. | Matching placebo was given up to 4 weeks. |
| Measure Participants | 94 | 93 |
| Day 1 (n=84, 89) |
0.4
(0.79)
|
0.1
(0.70)
|
| Day 8 (n=74, 48) |
0.5
(0.81)
|
0.3
(0.78)
|
| Day 15 (n=67, 41) |
0.4
(0.76)
|
0.4
(0.86)
|
| Day 22 (n=63, 40) |
0.4
(0.73)
|
0.5
(0.78)
|
| Day 28 (n=72, 47) |
0.4
(0.74)
|
0.4
(0.77)
|
| Title | Total Pain Relief (TOTPAR) Score During the Open-Label Period |
|---|---|
| Description | The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief. |
| Time Frame | Day 1 and Day 8 of open-label period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for each time point. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets). |
| Measure Participants | 277 |
| Day 1 (n=274) |
2.6
(1.89)
|
| Day 8 (n=219) |
3.5
(1.95)
|
| Title | Total Pain Relief (TOTPAR) Score During the Double-Blind Period |
|---|---|
| Description | The TOTPAR is defined as sum of PAR at 2 hours after dosing and the PAR at 4 hours after dosing on each evaluation day. Pain relief as evaluated on 5-stage scale with a score ranging from 0=no relief and 4=complete relief. Total possible score range for TOTPAR is 0=no relief to 8=complete relief. |
| Time Frame | Day 1, 8, 15, 22 and 28 of double-blind period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks. | Matching placebo was given up to 4 weeks. |
| Measure Participants | 94 | 93 |
| Day 1 (n=84, 89) |
3.5
(1.97)
|
2.3
(2.00)
|
| Day 8 (n=74, 48) |
3.8
(2.00)
|
2.6
(2.05)
|
| Day 15 (n=67, 41) |
4.1
(2.04)
|
3.3
(2.10)
|
| Day 22 (n=63, 40) |
4.3
(1.91)
|
3.6
(2.42)
|
| Day 28 (n=72, 47) |
4.2
(1.99)
|
3.3
(2.50)
|
| Title | Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Open-Label Period |
|---|---|
| Description | The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0=no relief to 4=complete relief. |
| Time Frame | Day 1, and Day 8 of open-label period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for each time point. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets). |
| Measure Participants | 277 |
| Day 1 (n=274) |
3.5
(2.74)
|
| Day 8 (n=219) |
4.1
(2.50)
|
| Title | Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Double-Blind Period |
|---|---|
| Description | The SPRID is defined as sum of PID and PAR Scores at 2 hours and 4 hours after the dosing on each evaluation day. The overall possible score ranges for SPRID is -4=worst to 14=best. The PID was calculated as PI at pre-dose on Day 1, 8, 15, 22, 28 minus PI at post-dose time point (i.e., 2 hours and 4 hours) on Day 1, 8, 15, 22, 28 respectively. Baseline PI score ranges from 1=minor to 3=severe, post-baseline PI score ranges from 0=none to 3=severe. Total possible score range for PID: -2=worst to 3=best and PAR was evaluated based on 5-stage scale with a score ranging from 0 to 4, wherein, 0=no relief and 4=complete relief. |
| Time Frame | Day 1, 8, 15, 22 and 28 of double-blind period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks. | Matching placebo was given up to 4 weeks. |
| Measure Participants | 94 | 93 |
| Day 1 (n=84, 89) |
3.9
(2.37)
|
2.4
(2.30)
|
| Day 8 (n=74, 48) |
4.3
(2.32)
|
3.0
(2.48)
|
| Day 15 (n=67, 41) |
4.6
(2.46)
|
3.7
(2.61)
|
| Day 22 (n=63, 40) |
4.7
(2.27)
|
4.0
(2.81)
|
| Day 28 (n=72, 47) |
4.6
(2.35)
|
3.7
(2.90)
|
| Title | Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Total Score at Day 14 of Open-Label Period |
|---|---|
| Description | The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability. |
| Time Frame | Day 1 and Day 14 of open-label period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included who received at least one dose of study drug and had the lumbago as the target disease. Here 'n' signifies number of participants evaluable for this outcome measure at each time point. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets). |
| Measure Participants | 160 |
| Day 1 (n=160) |
9.1
(4.89)
|
| Change at Day 14 (n=126) |
-2.6
(3.28)
|
| Title | Change From Baseline in RDQ Total Score at Day 28 of Double-Blind Period |
|---|---|
| Description | The RDQ is self-administered measure of disability caused by low back pain and consists of 24 statements. The total score ranges from 0=no disability to 24=severe disability. The higher scores indicate greater physical disability. |
| Time Frame | Day 1 and Day 28 of double-blind period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included participants received at least one dose of the study drug and had the lumbago as the target disease. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks. | Matching placebo was given up to 4 weeks. |
| Measure Participants | 55 | 57 |
| Day 1 (n=55, 57) |
6.5
(4.41)
|
6.0
(4.57)
|
| Change at Day 28 (n=55, 57) |
-0.5
(3.08)
|
0.8
(3.69)
|
| Title | Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire Score at Day 14 of Open-Label Period |
|---|---|
| Description | The WOMAC questionnaire is an activity of daily living (ADL) indicator for Knee Osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL. |
| Time Frame | Day 1 and Day 14 of open-label period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included who received at least one dose of study drug and had the knee osteoarthritis as the target disease. Here 'n' signifies number of participants evaluable for this outcome measure at each time point. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks. |
| Measure Participants | 117 |
| Day 1; Pain (n=117) |
4.4
(1.96)
|
| Change at Day 14; Pain (n=90) |
-1.9
(1.66)
|
| Day 1; Stiffness (n=117) |
4.2
(2.31)
|
| Change at Day 14; Stiffness (n=90) |
-1.5
(2.09)
|
| Day 1; EODA (n=117) |
3.7
(1.89)
|
| Change at Day 14; EODA (n=90) |
-1.5
(1.38)
|
| Day 1; General index (n=117) |
4.1
(1.82)
|
| Change at Day 14; General index (n=90) |
-1.7
(1.39)
|
| Title | Change From Baseline in WOMAC Questionnaire Score at Day 28 of Double-Blind Period |
|---|---|
| Description | The WOMAC questionnaire is an activity of daily living (ADL) indicator for knee osteoarthritis and designed to capture the elements of pain, stiffness, extent of obstruction to daily activities (EODA) and general index. The score for each element ranges from 0=better ADL to 10=worse ADL. |
| Time Frame | Day 1 and Day 28 of double-blind period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included who received at least one dose of study drug and had the knee osteoarthritis as the target disease. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks. | Matching placebo was given up to 4 weeks. |
| Measure Participants | 39 | 36 |
| Day 1; Pain (n=39, 36) |
2.6
(1.46)
|
2.2
(1.20)
|
| Change at Day 28; Pain (n=39, 36) |
-0.3
(1.02)
|
0.5
(1.49)
|
| Day 1; Stiffness (n=39, 36) |
2.7
(1.94)
|
2.4
(1.72)
|
| Change at Day 28; Stiffness (n=39, 36) |
-0.2
(1.33)
|
0.2
(1.99)
|
| Day 1; EODA (n=39, 36) |
2.3
(1.68)
|
1.9
(1.45)
|
| Change at Day 28; EODA (n=39, 36) |
-0.5
(0.58)
|
0.4
(1.30)
|
| Day 1; General index (n=39, 36) |
2.5
(1.48)
|
2.2
(1.23)
|
| Change at Day 28; General index (n=39, 36) |
-0.4
(0.65)
|
0.4
(1.29)
|
| Title | Change From Baseline in Short Form-36 (SF-36) Score at Day 14 of Open-Label Period |
|---|---|
| Description | The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status. |
| Time Frame | Day 1 and Day 14 of open-label period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included who received at least one dose of study drug. Here 'n' signifies number of participants evaluable for this outcome measure at each time point. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Open-Label) |
|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets). |
| Measure Participants | 277 |
| Day 1; Physical functioning (n=277) |
34.3
(15.23)
|
| Change at Day 14; Physical functioning (n=216) |
3.9
(10.39)
|
| Day 1; Role-physical (n=216) |
37.0
(13.62)
|
| Change at Day 14; Role-physical (n=216) |
4.3
(11.10)
|
| Day 1; Bodily pain (n=277) |
34.8
(6.59)
|
| Change at Day 14; Bodily pain (n=216) |
5.4
(7.04)
|
| Day 1; General health (n=277) |
45.4
(9.01)
|
| Change at Day 14; General health (n=216) |
2.7
(6.31)
|
| Day 1; Vitality (n=277) |
45.1
(9.43)
|
| Change at Day 14; Vitality (n=216) |
2.3
(8.10)
|
| Day 1; Social functioning (n=277) |
43.5
(12.48)
|
| Change at Day 14; Social functioning (n=277) |
2.0
(10.76)
|
| Day 1; Role-emotional (n=277) |
43.2
(12.95)
|
| Change at Day 14; Role-emotional (n=216) |
2.5
(11.36)
|
| Day 1; Mental health (n=277) |
46.8
(9.69)
|
| Change at Day 14; Mental health (n=216) |
2.8
(8.59)
|
| Title | Change From Baseline in SF-36 at Day 28 of Double-Blind Period |
|---|---|
| Description | The SF-36 is a survey of participant health and quality of life. It consists of 8 sub-scales, which are the weighted sums of the questions in their section. The 8 sub-scales are: physical functioning, role-physical, role-emotional, general health, social functioning, bodily pain, vitality, mental health. Each item is scored on a scale ranging from 0-100. Higher score defines a more favorable health status or a better mental status. |
| Time Frame | Day 1 and Day 28 of double-blind period |
Outcome Measure Data
| Analysis Population Description |
|---|
| Efficacy analysis set included participants received at least one dose of the study drug. Here 'n' signifies number of participants evaluable at each time point for each arm respectively. |
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) |
|---|---|---|
| Arm/Group Description | Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks. | Matching placebo was given up to 4 weeks. |
| Measure Participants | 94 | 93 |
| Day 1; Physical functioning (n=94,93) |
39.0
(12.28)
|
39.7
(13.36)
|
| Change at Day 28; Physical functioning (n=94,93) |
1.1
(8.49)
|
-1.6
(10.03)
|
| Day 1; Role-physical (n=94,93) |
40.5
(12.84)
|
41.8
(12.24)
|
| Change at Day 28; Role-physical (n=94,93) |
0.8
(11.87)
|
-0.6
(9.54)
|
| Day 1; Bodily pain (n=94,93) |
41.0
(7.68)
|
39.3
(7.27)
|
| Change at Day 28; Bodily pain (n=94,93) |
2.4
(7.24)
|
0.3
(7.77)
|
| Day 1; General health (n=94,93) |
49.1
(9.23)
|
48.0
(9.33)
|
| Change at Day 28; General health (n=94,93) |
0.4
(7.11)
|
-1.2
(5.97)
|
| Day 1; Vitality (n=94,93) |
47.3
(9.58)
|
47.4
(8.49)
|
| Change at Day 28; Vitality (n=94,93) |
3.1
(7.40)
|
0.1
(7.51)
|
| Day 1; Social functioning (n=94,93) |
46.4
(12.68)
|
45.7
(11.48)
|
| Change at Day 28; Social functioning (n=94,93) |
1.6
(11.32)
|
0.4
(10.07)
|
| Day 1; Role-emotional (n=94,93) |
46.7
(11.46)
|
45.8
(11.72)
|
| Change at Day 28; Role-emotional (n=94,93) |
0.0
(9.49)
|
-1.0
(9.99)
|
| Day 1; Mental health (n=94,93) |
50.4
(9.14)
|
49.6
(8.80)
|
| Change at Day 28; Mental health (n=94,93) |
2.2
(7.29)
|
-0.7
(8.17)
|
Adverse Events
| Time Frame | From the start of open-label period until 7 days after the last dose of study medication | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||
| Arm/Group Title | Tramadol Hydrochloride and Acetaminophen (Open-Label) | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) | |||
| Arm/Group Description | Fixed dose combination of tramadol 37.5 milligram (mg)/acetaminophen 325 mg, 1 or 2 tablets 4 times daily was given for one week; dose level was fixed for each participant during the second week based on analgesic efficacy and tolerability (maximum daily dose was 8 tablets). | Fixed dose combination of tramadol 37.5 mg/acetaminophen 325 mg, 1 or 2 tablets (same dose [number of tablets] as that for the second week in the open-label period) was given 4 times daily up to 4 weeks. | Matching placebo was given up to 4 weeks. | |||
All Cause Mortality |
||||||
| Tramadol Hydrochloride and Acetaminophen (Open-Label) | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Tramadol Hydrochloride and Acetaminophen (Open-Label) | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/277 (0%) | 1/94 (1.1%) | 0/93 (0%) | |||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||
| Rectal cancer | 0/277 (0%) | 1/94 (1.1%) | 0/93 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Tramadol Hydrochloride and Acetaminophen (Open-Label) | Tramadol Hydrochloride and Acetaminophen (Double-Blind) | Placebo (Double-Blind) | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 222/277 (80.1%) | 47/94 (50%) | 44/93 (47.3%) | |||
| Cardiac disorders | ||||||
| Palpitations | 0/277 (0%) | 1/94 (1.1%) | 0/93 (0%) | |||
| Ear and labyrinth disorders | ||||||
| Tinnitus | 2/277 (0.7%) | 0/94 (0%) | 0/93 (0%) | |||
| Meniere's disease | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Rotatory vertigo | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Ear discomfort | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Eye disorders | ||||||
| Abnormal sensation in the eye | 0/277 (0%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Dry eye | 0/277 (0%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Vision impairment | 0/277 (0%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Gastrointestinal disorders | ||||||
| Nausea | 125/277 (45.1%) | 5/94 (5.3%) | 3/93 (3.2%) | |||
| Vomiting | 76/277 (27.4%) | 1/94 (1.1%) | 1/93 (1.1%) | |||
| Constipation | 52/277 (18.8%) | 3/94 (3.2%) | 0/93 (0%) | |||
| Gastric discomfort | 12/277 (4.3%) | 1/94 (1.1%) | 1/93 (1.1%) | |||
| Upper abdominal pain | 9/277 (3.2%) | 2/94 (2.1%) | 2/93 (2.2%) | |||
| Diarrhea | 3/277 (1.1%) | 1/94 (1.1%) | 5/93 (5.4%) | |||
| Dry mouth | 3/277 (1.1%) | 0/94 (0%) | 0/93 (0%) | |||
| Abdominal pain | 2/277 (0.7%) | 0/94 (0%) | 2/93 (2.2%) | |||
| Stomatitis | 2/277 (0.7%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Cheilitis | 1/277 (0.4%) | 1/94 (1.1%) | 0/93 (0%) | |||
| Indigestion | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Gastrointestinal disorder | 1/277 (0.4%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Abnormal gastrointestinal sounds | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Enteritis | 0/277 (0%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Food poisoning | 0/277 (0%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Gastritis | 0/277 (0%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Glossitis | 0/277 (0%) | 1/94 (1.1%) | 0/93 (0%) | |||
| General disorders | ||||||
| Abnormal sensation | 15/277 (5.4%) | 3/94 (3.2%) | 0/93 (0%) | |||
| Dry mouth | 10/277 (3.6%) | 1/94 (1.1%) | 1/93 (1.1%) | |||
| Lassitude | 5/277 (1.8%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Asthenia | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Chest discomfort | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Fever | 1/277 (0.4%) | 1/94 (1.1%) | 0/93 (0%) | |||
| Chest pain | 0/277 (0%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Hepatobiliary disorders | ||||||
| Liver function abnormality | 2/277 (0.7%) | 1/94 (1.1%) | 1/93 (1.1%) | |||
| Infections and infestations | ||||||
| Nasopharyngitis | 6/277 (2.2%) | 5/94 (5.3%) | 17/93 (18.3%) | |||
| Oral herpes | 2/277 (0.7%) | 0/94 (0%) | 0/93 (0%) | |||
| Cystitis | 1/277 (0.4%) | 1/94 (1.1%) | 0/93 (0%) | |||
| Sty | 1/277 (0.4%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Upper respiratory infection | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Pharyngitis | 0/277 (0%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Injury, poisoning and procedural complications | ||||||
| Fall/tumble | 3/277 (1.1%) | 2/94 (2.1%) | 0/93 (0%) | |||
| Traffic accident | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Neck injury | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Arthropod bite | 0/277 (0%) | 1/94 (1.1%) | 0/93 (0%) | |||
| Arthropod sting | 0/277 (0%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Wound | 0/277 (0%) | 1/94 (1.1%) | 2/93 (2.2%) | |||
| Investigations | ||||||
| Blood creatine phosphokinase increased | 5/277 (1.8%) | 2/94 (2.1%) | 3/93 (3.2%) | |||
| Blood lactate dehydrogenase increased | 3/277 (1.1%) | 2/94 (2.1%) | 0/93 (0%) | |||
| γ-glutamyl transferase increased | 3/277 (1.1%) | 11/94 (11.7%) | 3/93 (3.2%) | |||
| Blood bilirubin increased | 2/277 (0.7%) | 0/94 (0%) | 0/93 (0%) | |||
| Blood pressure elevated | 2/277 (0.7%) | 1/94 (1.1%) | 0/93 (0%) | |||
| Blood triglycerides increased | 2/277 (0.7%) | 4/94 (4.3%) | 0/93 (0%) | |||
| Blood uric acid increased | 2/277 (0.7%) | 1/94 (1.1%) | 0/93 (0%) | |||
| Urine glucose positive | 2/277 (0.7%) | 1/94 (1.1%) | 1/93 (1.1%) | |||
| Urine blood positive | 2/277 (0.7%) | 0/94 (0%) | 0/93 (0%) | |||
| Aspartate aminotransferase increased | 1/277 (0.4%) | 2/94 (2.1%) | 0/93 (0%) | |||
| Blood creatinine decreased | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Blood creatinine increased | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Blood urea increased | 1/277 (0.4%) | 5/94 (5.3%) | 1/93 (1.1%) | |||
| Neutrophil count increased | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Eosinophil fraction increased | 1/277 (0.4%) | 1/94 (1.1%) | 1/93 (1.1%) | |||
| Neutrophil fraction increased | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Lymphocyte fraction decreased | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Urine protein positive | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Alanine aminotransferase increased | 0/277 (0%) | 2/94 (2.1%) | 2/93 (2.2%) | |||
| Eosinophil count increased | 0/277 (0%) | 2/94 (2.1%) | 0/93 (0%) | |||
| Blood K increased | 0/277 (0%) | 1/94 (1.1%) | 0/93 (0%) | |||
| Hemoglobin decreased | 0/277 (0%) | 1/94 (1.1%) | 0/93 (0%) | |||
| Lipids increased | 0/277 (0%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Liver function test abnormality | 0/277 (0%) | 1/94 (1.1%) | 0/93 (0%) | |||
| Weight loss | 0/277 (0%) | 1/94 (1.1%) | 0/93 (0%) | |||
| White blood cell count increased | 0/277 (0%) | 1/94 (1.1%) | 0/93 (0%) | |||
| Platelet count increased | 0/277 (0%) | 1/94 (1.1%) | 0/93 (0%) | |||
| Kidney function test abnormality | 0/277 (0%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Metabolism and nutrition disorders | ||||||
| Anorexia | 2/277 (0.7%) | 1/94 (1.1%) | 0/93 (0%) | |||
| Loss of appetite | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Musculoskeletal and connective tissue disorders | ||||||
| Back pain | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Muscle spasms | 1/277 (0.4%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Leg mass | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Tenosynovitis | 0/277 (0%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Myalgia | 0/277 (0%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Osteoarthritis | 0/277 (0%) | 1/94 (1.1%) | 1/93 (1.1%) | |||
| Nervous system disorders | ||||||
| Somnolence | 77/277 (27.8%) | 1/94 (1.1%) | 2/93 (2.2%) | |||
| Dizziness | 45/277 (16.2%) | 3/94 (3.2%) | 0/93 (0%) | |||
| Headache | 21/277 (7.6%) | 1/94 (1.1%) | 2/93 (2.2%) | |||
| Attention deficit | 2/277 (0.7%) | 0/94 (0%) | 0/93 (0%) | |||
| Dysgeusia | 2/277 (0.7%) | 0/94 (0%) | 0/93 (0%) | |||
| Hypoesthesia | 2/277 (0.7%) | 0/94 (0%) | 0/93 (0%) | |||
| Tremors | 2/277 (0.7%) | 0/94 (0%) | 0/93 (0%) | |||
| Positional vertigo | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Convulsions | 0/277 (0%) | 1/94 (1.1%) | 0/93 (0%) | |||
| Migraine | 0/277 (0%) | 1/94 (1.1%) | 0/93 (0%) | |||
| Psychiatric disorders | ||||||
| Insomnia | 2/277 (0.7%) | 3/94 (3.2%) | 0/93 (0%) | |||
| Anxiety | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Renal and urinary disorders | ||||||
| Hematuria | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Urination disorder | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Ischuria | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Respiratory, thoracic and mediastinal disorders | ||||||
| Hiccups | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Cough | 0/277 (0%) | 1/94 (1.1%) | 0/93 (0%) | |||
| Upper respiratory inflammation | 0/277 (0%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Oropharyngeal pain | 0/277 (0%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Skin and subcutaneous tissue disorders | ||||||
| Pruritus | 18/277 (6.5%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Excessive perspiration | 13/277 (4.7%) | 0/94 (0%) | 0/93 (0%) | |||
| Cold sweat | 5/277 (1.8%) | 0/94 (0%) | 0/93 (0%) | |||
| Exanthema | 5/277 (1.8%) | 0/94 (0%) | 0/93 (0%) | |||
| Allergic pruritus | 5/277 (1.8%) | 0/94 (0%) | 0/93 (0%) | |||
| Eczema | 2/277 (0.7%) | 0/94 (0%) | 0/93 (0%) | |||
| Ingrown nail | 2/277 (0.7%) | 0/94 (0%) | 0/93 (0%) | |||
| Systemic pruritus | 2/277 (0.7%) | 0/94 (0%) | 0/93 (0%) | |||
| Heat rash | 1/277 (0.4%) | 0/94 (0%) | 0/93 (0%) | |||
| Vascular disorders | ||||||
| Hot flashes | 4/277 (1.4%) | 0/94 (0%) | 1/93 (1.1%) | |||
| Hypertension | 2/277 (0.7%) | 0/94 (0%) | 0/93 (0%) | |||
| Blushing | 1/277 (0.4%) | 0/94 (0%) | 1/93 (1.1%) | |||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PIs is that the Sponsor can review results communications prior to public release.
Results Point of Contact
| Name/Title | Medical Director |
|---|---|
| Organization | Neuroscience Department, Clinical Science Division, R&D, JANSSEN PHARMACEUTICAL. K.K. |
| Phone | +81-3-4411-5509 |
Responsible Party:
Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier:
NCT00736853
Other Study ID Numbers:
- CR015112
- JNS013-JPN-04
First Posted:
Aug 18, 2008
Last Update Posted:
Sep 26, 2013
Last Verified:
Jul 1, 2013