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An Efficacy and Safety Study of Acetaminophen Plus Tramadol Hydrochloride (JNS013) in Participants With Chronic Pain

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ClinicalTrials.gov Identifier: NCT00736853
Recruitment Status : Completed
First Posted : August 18, 2008
Results First Posted : September 26, 2013
Last Update Posted : September 26, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Tramadol Hydrochloride Plus Acetaminophen (Open-Label)
Drug: Tramadol Hydrochloride Plus Acetaminophen (Double-Blind)
Drug: Placebo (Double-Blind)
Enrollment 321
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tramadol Hydrochloride and Acetaminophen (Open-Label) Tramadol Hydrochloride and Acetaminophen (Double-Blind) Placebo (Double-Blind)
Hide 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
Reason Not Completed
Physician Decision             2             0             0
Adverse Event             31             0             0
Withdrawal by Subject             16             0             0
Started but not treated             42             0             0
Failed to meet the transfer criteria             40             0             0
Unable to attend hospital appointments             1             0             0
Period Title: Double-Blind Period
Started 0 94 93
Completed 0 70 45
Not Completed 0 24 48
Reason Not Completed
Lack of Efficacy             0             19             42
Adverse Event             0             3             2
Withdrawal by Subject             0             1             4
Ineligible to participate the study             0             1             0
Arm/Group Title Entire Study Population
Hide 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 Number of Baseline Participants 277
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 277 participants
57.0  (17.5)
[1]
Measure Description: Efficacy analysis set: Participants who received at least 1 dose of study drug.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 277 participants
Female
168
  60.6%
Male
109
  39.4%
[1]
Measure Description: Efficacy analysis set: Participants who received at least 1 dose of study drug.
1.Primary Outcome
Title Number of Participants With Insufficient Pain Relief After the Start of Double-Blind Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 94 93
Measure Type: Number
Unit of Measure: number of participants
20 43
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Tramadol Hydrochloride and Acetaminophen (Double-Blind), Placebo (Double-Blind)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0001
Comments [Not Specified]
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
Estimation Comments [Not Specified]
2.Secondary Outcome
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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 277
Mean (Standard Deviation)
Unit of Measure: mm
Day 1 of open-label period 66.27  (13.69)
Change at Day 1 of double-blind period -28.17  (21.16)
3.Secondary Outcome
Title Change in the VAS24 Value From the Baseline at the Final Time Point of the Double-Blind Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 94 93
Mean (Standard Deviation)
Unit of Measure: mm
Day 1 30.33  (17.47) 31.18  (16.59)
Change at Day 28 -0.67  (18.14) 6.21  (22.50)
4.Secondary Outcome
Title Mean Pain Intensity (PI) Score During Open-Label Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 277
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
5.Secondary Outcome
Title Mean PI Score During Double-Blind Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 94 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
6.Secondary Outcome
Title Mean Pain Intensity Difference (PID) During the Open-Label Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 277
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
7.Secondary Outcome
Title Mean PID During the Double-Blind Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 94 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
8.Secondary Outcome
Title Mean Pain Relief (PAR) Score During the Open-Label Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 277
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
9.Secondary Outcome
Title Mean PAR Score During the Double-Blind Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 94 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
10.Secondary Outcome
Title Pain Intensity Difference and Pain Relief Scores (PRID) During the Open-Label Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 277
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
11.Secondary Outcome
Title Pain Intensity Difference and Pain Relief Scores (PRID) During the Double-Blind Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 94 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
12.Secondary Outcome
Title Sum of Pain Intensity Difference (SPID) Score During the Open-Label Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 277
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 1 (n=274) 0.9  (1.17)
Day 8 (n=219) 0.5  (0.93)
13.Secondary Outcome
Title Sum of Pain Intensity Difference (SPID) Score During the Double-Blind Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 94 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
14.Secondary Outcome
Title Total Pain Relief (TOTPAR) Score During the Open-Label Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 277
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 1 (n=274) 2.6  (1.89)
Day 8 (n=219) 3.5  (1.95)
15.Secondary Outcome
Title Total Pain Relief (TOTPAR) Score During the Double-Blind Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 94 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
16.Secondary Outcome
Title Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Open-Label Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 277
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 1 (n=274) 3.5  (2.74)
Day 8 (n=219) 4.1  (2.50)
17.Secondary Outcome
Title Sum of Pain Relief Combined With Pain Intensity Difference (SPRID) Score During the Double-Blind Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 94 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
18.Secondary Outcome
Title Change From Baseline in Roland Morris Disability Questionnaire (RDQ) Total Score at Day 14 of Open-Label Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 160
Mean (Standard Deviation)
Unit of Measure: units on a scale
Day 1 (n=160) 9.1  (4.89)
Change at Day 14 (n=126) -2.6  (3.28)
19.Secondary Outcome
Title Change From Baseline in RDQ Total Score at Day 28 of Double-Blind Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 55 57
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
20.Secondary Outcome
Title Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Questionnaire Score at Day 14 of Open-Label Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 117
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
21.Secondary Outcome
Title Change From Baseline in WOMAC Questionnaire Score at Day 28 of Double-Blind Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 39 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
22.Secondary Outcome
Title Change From Baseline in Short Form-36 (SF-36) Score at Day 14 of Open-Label Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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).
Overall Number of Participants Analyzed 277
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
23.Secondary Outcome
Title Change From Baseline in SF-36 at Day 28 of Double-Blind Period
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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.
Overall Number of Participants Analyzed 94 93
Mean (Standard Deviation)
Unit of Measure: units on a scale
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)
Time Frame From the start of open-label period until 7 days after the last dose of study medication
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tramadol Hydrochloride and Acetaminophen (Open-Label) Tramadol Hydrochloride and Acetaminophen (Double-Blind) Placebo (Double-Blind)
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tramadol Hydrochloride and Acetaminophen (Open-Label) Tramadol Hydrochloride and Acetaminophen (Double-Blind) Placebo (Double-Blind)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/277 (0.00%)   1/94 (1.06%)   0/93 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Rectal cancer * 1  0/277 (0.00%)  1/94 (1.06%)  0/93 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA/J V11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tramadol Hydrochloride and Acetaminophen (Open-Label) Tramadol Hydrochloride and Acetaminophen (Double-Blind) Placebo (Double-Blind)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   222/277 (80.14%)   47/94 (50.00%)   44/93 (47.31%) 
Cardiac disorders       
Palpitations * 1  0/277 (0.00%)  1/94 (1.06%)  0/93 (0.00%) 
Ear and labyrinth disorders       
Tinnitus * 1  2/277 (0.72%)  0/94 (0.00%)  0/93 (0.00%) 
Meniere’s disease * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Rotatory vertigo * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Ear discomfort * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Eye disorders       
Abnormal sensation in the eye * 1  0/277 (0.00%)  0/94 (0.00%)  1/93 (1.08%) 
Dry eye * 1  0/277 (0.00%)  0/94 (0.00%)  1/93 (1.08%) 
Vision impairment * 1  0/277 (0.00%)  0/94 (0.00%)  1/93 (1.08%) 
Gastrointestinal disorders       
Nausea * 1  125/277 (45.13%)  5/94 (5.32%)  3/93 (3.23%) 
Vomiting * 1  76/277 (27.44%)  1/94 (1.06%)  1/93 (1.08%) 
Constipation * 1  52/277 (18.77%)  3/94 (3.19%)  0/93 (0.00%) 
Gastric discomfort * 1  12/277 (4.33%)  1/94 (1.06%)  1/93 (1.08%) 
Upper abdominal pain * 1  9/277 (3.25%)  2/94 (2.13%)  2/93 (2.15%) 
Diarrhea * 1  3/277 (1.08%)  1/94 (1.06%)  5/93 (5.38%) 
Dry mouth * 1  3/277 (1.08%)  0/94 (0.00%)  0/93 (0.00%) 
Abdominal pain * 1  2/277 (0.72%)  0/94 (0.00%)  2/93 (2.15%) 
Stomatitis * 1  2/277 (0.72%)  0/94 (0.00%)  1/93 (1.08%) 
Cheilitis * 1  1/277 (0.36%)  1/94 (1.06%)  0/93 (0.00%) 
Indigestion * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Gastrointestinal disorder * 1  1/277 (0.36%)  0/94 (0.00%)  1/93 (1.08%) 
Abnormal gastrointestinal sounds * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Enteritis * 1  0/277 (0.00%)  0/94 (0.00%)  1/93 (1.08%) 
Food poisoning * 1  0/277 (0.00%)  0/94 (0.00%)  1/93 (1.08%) 
Gastritis * 1  0/277 (0.00%)  0/94 (0.00%)  1/93 (1.08%) 
Glossitis * 1  0/277 (0.00%)  1/94 (1.06%)  0/93 (0.00%) 
General disorders       
Abnormal sensation * 1  15/277 (5.42%)  3/94 (3.19%)  0/93 (0.00%) 
Dry mouth * 1  10/277 (3.61%)  1/94 (1.06%)  1/93 (1.08%) 
Lassitude * 1  5/277 (1.81%)  0/94 (0.00%)  1/93 (1.08%) 
Asthenia * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Chest discomfort * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Fever * 1  1/277 (0.36%)  1/94 (1.06%)  0/93 (0.00%) 
Chest pain * 1  0/277 (0.00%)  0/94 (0.00%)  1/93 (1.08%) 
Hepatobiliary disorders       
Liver function abnormality * 1  2/277 (0.72%)  1/94 (1.06%)  1/93 (1.08%) 
Infections and infestations       
Nasopharyngitis * 1  6/277 (2.17%)  5/94 (5.32%)  17/93 (18.28%) 
Oral herpes * 1  2/277 (0.72%)  0/94 (0.00%)  0/93 (0.00%) 
Cystitis * 1  1/277 (0.36%)  1/94 (1.06%)  0/93 (0.00%) 
Sty * 1  1/277 (0.36%)  0/94 (0.00%)  1/93 (1.08%) 
Upper respiratory infection * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Pharyngitis * 1  0/277 (0.00%)  0/94 (0.00%)  1/93 (1.08%) 
Injury, poisoning and procedural complications       
Fall/tumble * 1  3/277 (1.08%)  2/94 (2.13%)  0/93 (0.00%) 
Traffic accident * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Neck injury * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Arthropod bite * 1  0/277 (0.00%)  1/94 (1.06%)  0/93 (0.00%) 
Arthropod sting * 1  0/277 (0.00%)  0/94 (0.00%)  1/93 (1.08%) 
Wound * 1  0/277 (0.00%)  1/94 (1.06%)  2/93 (2.15%) 
Investigations       
Blood creatine phosphokinase increased * 1  5/277 (1.81%)  2/94 (2.13%)  3/93 (3.23%) 
Blood lactate dehydrogenase increased * 1  3/277 (1.08%)  2/94 (2.13%)  0/93 (0.00%) 
γ-glutamyl transferase increased * 1  3/277 (1.08%)  11/94 (11.70%)  3/93 (3.23%) 
Blood bilirubin increased * 1  2/277 (0.72%)  0/94 (0.00%)  0/93 (0.00%) 
Blood pressure elevated * 1  2/277 (0.72%)  1/94 (1.06%)  0/93 (0.00%) 
Blood triglycerides increased * 1  2/277 (0.72%)  4/94 (4.26%)  0/93 (0.00%) 
Blood uric acid increased * 1  2/277 (0.72%)  1/94 (1.06%)  0/93 (0.00%) 
Urine glucose positive * 1  2/277 (0.72%)  1/94 (1.06%)  1/93 (1.08%) 
Urine blood positive * 1  2/277 (0.72%)  0/94 (0.00%)  0/93 (0.00%) 
Aspartate aminotransferase increased * 1  1/277 (0.36%)  2/94 (2.13%)  0/93 (0.00%) 
Blood creatinine decreased * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Blood creatinine increased * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Blood urea increased * 1  1/277 (0.36%)  5/94 (5.32%)  1/93 (1.08%) 
Neutrophil count increased * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Eosinophil fraction increased * 1  1/277 (0.36%)  1/94 (1.06%)  1/93 (1.08%) 
Neutrophil fraction increased * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Lymphocyte fraction decreased * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Urine protein positive * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Alanine aminotransferase increased * 1  0/277 (0.00%)  2/94 (2.13%)  2/93 (2.15%) 
Eosinophil count increased * 1  0/277 (0.00%)  2/94 (2.13%)  0/93 (0.00%) 
Blood K increased * 1  0/277 (0.00%)  1/94 (1.06%)  0/93 (0.00%) 
Hemoglobin decreased * 1  0/277 (0.00%)  1/94 (1.06%)  0/93 (0.00%) 
Lipids increased * 1  0/277 (0.00%)  0/94 (0.00%)  1/93 (1.08%) 
Liver function test abnormality * 1  0/277 (0.00%)  1/94 (1.06%)  0/93 (0.00%) 
Weight loss * 1  0/277 (0.00%)  1/94 (1.06%)  0/93 (0.00%) 
White blood cell count increased * 1  0/277 (0.00%)  1/94 (1.06%)  0/93 (0.00%) 
Platelet count increased * 1  0/277 (0.00%)  1/94 (1.06%)  0/93 (0.00%) 
Kidney function test abnormality * 1  0/277 (0.00%)  0/94 (0.00%)  1/93 (1.08%) 
Metabolism and nutrition disorders       
Anorexia * 1  2/277 (0.72%)  1/94 (1.06%)  0/93 (0.00%) 
Loss of appetite * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Musculoskeletal and connective tissue disorders       
Back pain * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Muscle spasms * 1  1/277 (0.36%)  0/94 (0.00%)  1/93 (1.08%) 
Leg mass * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Tenosynovitis * 1  0/277 (0.00%)  0/94 (0.00%)  1/93 (1.08%) 
Myalgia * 1  0/277 (0.00%)  0/94 (0.00%)  1/93 (1.08%) 
Osteoarthritis * 1  0/277 (0.00%)  1/94 (1.06%)  1/93 (1.08%) 
Nervous system disorders       
Somnolence * 1  77/277 (27.80%)  1/94 (1.06%)  2/93 (2.15%) 
Dizziness * 1  45/277 (16.25%)  3/94 (3.19%)  0/93 (0.00%) 
Headache * 1  21/277 (7.58%)  1/94 (1.06%)  2/93 (2.15%) 
Attention deficit * 1  2/277 (0.72%)  0/94 (0.00%)  0/93 (0.00%) 
Dysgeusia * 1  2/277 (0.72%)  0/94 (0.00%)  0/93 (0.00%) 
Hypoesthesia * 1  2/277 (0.72%)  0/94 (0.00%)  0/93 (0.00%) 
Tremors * 1  2/277 (0.72%)  0/94 (0.00%)  0/93 (0.00%) 
Positional vertigo * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Convulsions * 1  0/277 (0.00%)  1/94 (1.06%)  0/93 (0.00%) 
Migraine * 1  0/277 (0.00%)  1/94 (1.06%)  0/93 (0.00%) 
Psychiatric disorders       
Insomnia * 1  2/277 (0.72%)  3/94 (3.19%)  0/93 (0.00%) 
Anxiety * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Renal and urinary disorders       
Hematuria * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Urination disorder * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Ischuria * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Hiccups * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Cough * 1  0/277 (0.00%)  1/94 (1.06%)  0/93 (0.00%) 
Upper respiratory inflammation * 1  0/277 (0.00%)  0/94 (0.00%)  1/93 (1.08%) 
Oropharyngeal pain * 1  0/277 (0.00%)  0/94 (0.00%)  1/93 (1.08%) 
Skin and subcutaneous tissue disorders       
Pruritus * 1  18/277 (6.50%)  0/94 (0.00%)  1/93 (1.08%) 
Excessive perspiration * 1  13/277 (4.69%)  0/94 (0.00%)  0/93 (0.00%) 
Cold sweat * 1  5/277 (1.81%)  0/94 (0.00%)  0/93 (0.00%) 
Exanthema * 1  5/277 (1.81%)  0/94 (0.00%)  0/93 (0.00%) 
Allergic pruritus * 1  5/277 (1.81%)  0/94 (0.00%)  0/93 (0.00%) 
Eczema * 1  2/277 (0.72%)  0/94 (0.00%)  0/93 (0.00%) 
Ingrown nail * 1  2/277 (0.72%)  0/94 (0.00%)  0/93 (0.00%) 
Systemic pruritus * 1  2/277 (0.72%)  0/94 (0.00%)  0/93 (0.00%) 
Heat rash * 1  1/277 (0.36%)  0/94 (0.00%)  0/93 (0.00%) 
Vascular disorders       
Hot flashes * 1  4/277 (1.44%)  0/94 (0.00%)  1/93 (1.08%) 
Hypertension * 1  2/277 (0.72%)  0/94 (0.00%)  0/93 (0.00%) 
Blushing * 1  1/277 (0.36%)  0/94 (0.00%)  1/93 (1.08%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA/J V11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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     History of Changes
Other Study ID Numbers: CR015112
JNS013-JPN-04
First Submitted: August 14, 2008
First Posted: August 18, 2008
Results First Submitted: April 12, 2013
Results First Posted: September 26, 2013
Last Update Posted: September 26, 2013