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Trial record 45 of 10804 for:    Placebo AND once

A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol HCl Once-a-Day Versus Placebo for the Treatment of Pain Due to Osteoarthritis

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ClinicalTrials.gov Identifier: NCT00833794
Recruitment Status : Completed
First Posted : February 2, 2009
Results First Posted : August 10, 2009
Last Update Posted : April 30, 2012
Sponsor:
Information provided by (Responsible Party):
Labopharm Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions Pain
Osteoarthritis
Interventions Drug: Tramadol Once a day
Drug: Placebo
Enrollment 1028
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1 Tramadol Once A Day 2 Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Open-label Phase
Started 1028 [1] 0 [2]
Entered run-in Period 1027 0
Received Open-Label Treatment 1023 0
Completed 646 [3] 0
Not Completed 382 0
Reason Not Completed
Adverse Event             225             0
Lack of Efficacy             28             0
Withdrawal by Subject             48             0
Physician Decision             20             0
Administrative reason             1             0
Protocol Violation             47             0
Did not complete wash-out period             12             0
enrolled in error (immediately D/C)             1             0
[1]
Enrolled. Population described in the baseline characteristics is 1023 patients (Open-Label safety).
[2]
No Placebo arm during open-label phase.
[3]
Randomized in double-blind phase
Period Title: Double-blind Phase
Started 432 [1] 214 [2]
Completed 326 165
Not Completed 106 49
Reason Not Completed
Adverse Event             44             11
Lack of Efficacy             34             22
Withdrawal by Subject             23             6
Physician Decision             4             7
Administrative reason             1             3
[1]
Of the 646 patients who completed the Open-Label phase, 432 were randomized to Tramadol Once A Day
[2]
Of the 646 patients who completed the Open-Label phase, 214 were randomized to Placebo
Arm/Group Title 1 Tramadol Once A Day 2 Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 432 214 646
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 214 participants 646 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
252
  58.3%
116
  54.2%
368
  57.0%
>=65 years
180
  41.7%
98
  45.8%
278
  43.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 432 participants 214 participants 646 participants
61.8  (9.0) 62.3  (8.9) 62.0  (9.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 432 participants 214 participants 646 participants
Female
275
  63.7%
133
  62.1%
408
  63.2%
Male
157
  36.3%
81
  37.9%
238
  36.8%
1.Primary Outcome
Title Pain Intensity Score as Measured by the 11-point Pain Intensity-Numerical Rating Scale Score at the End of the Study (Week 12 or Time of Discontinuation)
Hide Description The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain. The mean score at the end of the study (week 12 or time of discontinuation) was calculated.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.
Arm/Group Title 1 Tramadol Once A Day 2 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 431 214
Mean (Standard Deviation)
Unit of Measure: Points on a scale
4.3  (2.5) 4.8  (2.4)
2.Secondary Outcome
Title Pain Intensity Score (11-point PINRS) After 6 Weeks of Maintenance Treatment
Hide Description The Pain Intensity Score is an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain
Time Frame 6 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.
Arm/Group Title 1 Tramadol Once A Day 2 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 431 214
Mean (Standard Deviation)
Unit of Measure: Points on a scale
4.0  (2.2) 4.5  (2.2)
3.Secondary Outcome
Title Pain Intensity Score Stratified by Dose, at the End of the Study (Week 12 or Time of Discontinuation)
Hide Description Pain Intensity Score (an 11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) was stratified by final dose level, at week 12 or time of discontinuation. The final optimum dose level based upon efficacy and tolerability was kept for the entire study. The mean score was calculated.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.
Arm/Group Title 1 Tramadol Once A Day 2 Placebo Tramadol Once A Day 200 mg Tramadol Once A Day 300 mg
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 431 214 106 325
Mean (Standard Deviation)
Unit of Measure: Points on a scale
4.3  (2.5) 4.8  (2.4) 4.1  (2.4) 4.4  (2.6)
4.Secondary Outcome
Title WOMAC Pain Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)
Hide Description Mean WOMAC Pain Subscale score at week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme). The WOMAC pain subscale results from the sum of 5 pain questions. The maximum total score is 20.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.
Arm/Group Title 1 Tramadol Once A Day 2 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 431 214
Mean (Standard Deviation)
Unit of Measure: Points on a scale
6.9  (4.0) 7.5  (4.1)
5.Secondary Outcome
Title WOMAC Physical Function Subscale Score at the End of the Study (Week 12 or Time of Discontinuation)
Hide Description Mean WOMAC Physical Function Subscale score at week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 5-point Likert-scale ranging from no difficulty to extreme difficulty (0-none; 1-slight; 2-moderate; 3-severe; 4-extreme). The WOMAC Physical Function subscale results from the sum of 17 physical function questions and the maximum possible score is 68.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.
Arm/Group Title 1 Tramadol Once A Day 2 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 431 214
Mean (Standard Deviation)
Unit of Measure: Points on a scale
24.9  (13.4) 27.5  (13.8)
6.Secondary Outcome
Title Patient Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)
Hide Description This assessment of overall status integrates the effect of the treatment on pain, side effects, and the patient's expectation of pain relief. It is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.
Arm/Group Title 1 Tramadol Once A Day 2 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 425 210
Measure Type: Number
Unit of Measure: participants
1 = very much improved 86 27
2 = much improved 148 59
3 = minimally improved 108 58
4 = no change 49 42
5 = minimally worse 17 13
6 = much worse 17 8
7 = very much worse 0 3
7.Secondary Outcome
Title Physician Global Impression of Change at the End of the Study (Week 12 or Time of Discontinuation)
Hide Description This assessment of overall impression of study drug is made using a 7-point categorical scale (1 = very much improved; 2 = much improved; 3 = minimally improved; 4 = no change; 5 = minimally worse; 6 = much worse; 7 = very much worse)
Time Frame week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.
Arm/Group Title 1 Tramadol Once A Day 2 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 423 210
Measure Type: Number
Unit of Measure: participants
1 = very much improved 76 25
2 = much improved 154 71
3 = minimally improved 108 49
4 = no change 49 41
5 = minimally worse 21 17
6 = much worse 13 5
7 = very much worse 1 2
Not determined 1 0
8.Secondary Outcome
Title Time to Response
Hide Description Response was defined as a decrease of ≥1 point in an 11-point PINRS (11-point pain intensity numerical rating scale ranging from 0: no pain to 10: worst possible pain) from baseline to the last visit. The time to response was estimated using Kaplan-Meier analysis and a 95% CI for the median time was calculated.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.
Arm/Group Title 1 Tramadol Once A Day 2 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 431 214
Median (95% Confidence Interval)
Unit of Measure: days
1-point response
14
(14 to 14)
14
(14 to 14)
2-point response
14
(14 to 15)
15
(14 to 16)
3-point response
16
(15 to 35)
39
(35 to 56)
4-point response
15
(14 to 15)
35
(35 to 56)
5-point response
35
(15 to 35)
77
(56 to 99)
9.Secondary Outcome
Title Discontinuation Due to Lack of Efficacy
Hide Description The number of patients who discontinued due to lack of efficacy was reported.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.
Arm/Group Title 1 Tramadol Once A Day 2 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 431 214
Measure Type: Number
Unit of Measure: participants
34 22
10.Secondary Outcome
Title Discontinuation Due to Adverse Events
Hide Description The number of patients who discontinued due to adverse events (AEs). An AE is defined as any untoward medical event that occurs during the course of a clinical investigation in which a patient is administered a pharmaceutical or other therapeutic product. Its occurrence does not necessarily imply a causal relationship with the treatment.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis population: all randomized patients who received at least one dose of the randomized study medication regardless of the status of the post-dosing assessment.
Arm/Group Title 1 Tramadol Once A Day 2 Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 431 214
Measure Type: Number
Unit of Measure: participants
44 12
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1 Tramadol Once A Day 2 Placebo
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
1 Tramadol Once A Day 2 Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1 Tramadol Once A Day 2 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9      1    
Cardiac disorders     
Angina unstable *  1/1023 (0.10%)  1 0/214 (0.00%)  0
Gastrointestinal disorders     
Diverticulitis *  1/1023 (0.10%)  1 0/214 (0.00%)  0
General disorders     
Chest pain *  1/1023 (0.10%)  1 0/214 (0.00%)  0
Infections and infestations     
Hepatitis *  1/1023 (0.10%)  1 0/214 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Popliteal bursitis *  1/1023 (0.10%)  1 0/214 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Prostate cancer *  1/1023 (0.10%)  1 0/214 (0.00%)  0
Breast cancer *  1/1023 (0.10%)  1 0/214 (0.00%)  0
Nervous system disorders     
Grand mal convulsion *  1/1023 (0.10%)  1 0/214 (0.00%)  0
Ischaemic stroke *  0/1023 (0.00%)  0 1/214 (0.47%)  1
Syncope *  1/1023 (0.10%)  1 0/214 (0.00%)  0
Renal and urinary disorders     
Renal impairment *  1/1023 (0.10%)  1 0/214 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
1 Tramadol Once A Day 2 Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   136      29    
Gastrointestinal disorders     
Nausea *  66/432 (15.28%)  86 12/214 (5.61%)  12
Constipation *  61/432 (14.12%)  73 9/214 (4.21%)  12
Nervous system disorders     
Dizziness *  26/432 (6.02%)  28 7/214 (3.27%)  8
Somnolence *  29/432 (6.71%)  40 8/214 (3.74%)  9
*
Indicates events were collected by non-systematic assessment
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.
Prior to submitting results communications, the investigator shall allow Labopharm at least 30 days to review the proposed communication. If the proposed publication/disclosure risks Labopharm’s ability to patent any invention related to the study, the publication or disclosure will be modified or delayed to allow Labopharm to seek patent protection. This statement does not give Labopharm any editorial rights other than to restrict the disclosure of Labopharm’s confidential information.
Results Point of Contact
Name/Title: Director of Regulatory Affairs
Organization: Labopharm Inc.
Phone: 1 450 686 1017
Responsible Party: Labopharm Inc.
ClinicalTrials.gov Identifier: NCT00833794     History of Changes
Other Study ID Numbers: MDT3-005
First Submitted: January 29, 2009
First Posted: February 2, 2009
Results First Submitted: April 9, 2009
Results First Posted: August 10, 2009
Last Update Posted: April 30, 2012