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Trial record 25 of 10804 for:    Placebo AND once

A Four-Arm Study Comparing the Analgesic Efficacy and Safety of Tramadol Once a Day 100, 200 and 300 mg Versus Placebo for the Treatment of Pain Due to Osteoarthritis of the Knee (With 7-Day Follow-up)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00852917
Recruitment Status : Completed
First Posted : February 27, 2009
Results First Posted : June 2, 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
Condition Pain
Interventions Drug: Tramadol Once A Day
Drug: Placebo
Enrollment 552
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 1: Tramadol Once A Day 100mg 2: Tramadol Once A Day 200mg 3: Tramadol Once A Day 300mg 4: Placebo
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
Period Title: Overall Study
Started 106 111 108 227
Completed 62 65 50 134
Not Completed 44 46 58 93
Reason Not Completed
Adverse Event             13             20             35             17
Lack of Efficacy             21             11             11             47
Withdrawal by Subject             4             8             10             9
Physician Decision             6             7             2             19
Death             0             0             0             1
Arm/Group Title 1: Tramadol Once A Day 100mg 2: Tramadol Once A Day 200mg 3: Tramadol Once A Day 300mg 4: Placebo Total
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 106 111 108 227 552
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 111 participants 108 participants 227 participants 552 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0.0
Between 18 and 65 years
58
  54.7%
61
  55.0%
72
  66.7%
136
  59.9%
327.0
>=65 years
48
  45.3%
50
  45.0%
36
  33.3%
91
  40.1%
225.0
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 106 participants 111 participants 108 participants 227 participants 552 participants
62.9  (8.3) 61.1  (9.1) 60.3  (9.4) 61.1  (9.7) 61.3  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 106 participants 111 participants 108 participants 227 participants 552 participants
Female
65
  61.3%
67
  60.4%
72
  66.7%
140
  61.7%
344.0
Male
41
  38.7%
44
  39.6%
36
  33.3%
87
  38.3%
208.0
1.Primary Outcome
Title Patient Global Rating of Pain for the Study Period (12 Weeks)
Hide Description 3-item Likert-scale: "How do you rate overall pain relief with the drug?" with 3 possible answers: "very effective", "effective", or "ineffective". The average of ratings at visits 2-5 was calculated as median, rounded up to the closest integer.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)
Arm/Group Title 1: Tramadol Once A Day 100mg 2: Tramadol Once A Day 200mg 3: Tramadol Once A Day 300mg 4: Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 103 107 105 224
Measure Type: Number
Unit of Measure: participants
Very effective 19 25 27 28
Effective 49 55 57 102
Ineffective 34 27 21 93
2.Primary Outcome
Title Percentage Difference Between WOMAC Pain Subscale Score From Baseline to the End of the Study (Week 12)
Hide Description Percentage of difference in WOMAC Pain Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale (VAS) ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 of the questions.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.
Arm/Group Title 1: Tramadol Once A Day 100mg 2: Tramadol Once A Day 200mg 3: Tramadol Once A Day 300mg 4: Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 103 107 105 224
Mean (Standard Deviation)
Unit of Measure: Percentage difference in WOMAC Pain
41.6  (50.2) 42.8  (46.4) 46.0  (39.9) 32.3  (48.2)
3.Primary Outcome
Title Percentage Difference Between WOMAC Physical Function Subscale Score From Baseline to the End of the Study (Week 12)
Hide Description Percentage of difference in WOMAC Physical Function Subscale score between baseline and week 12. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no difficulty (0mm) to extreme difficulty (100mm). The WOMAC Physical Function subscale results from the sum of 17 of the questions.
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.
Arm/Group Title 1: Tramadol Once A Day 100mg 2: Tramadol Once A Day 200mg 3: Tramadol Once A Day 300mg 4: Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 103 107 105 224
Mean (Standard Deviation)
Unit of Measure: Percentage difference in WOMAC Physical
42.3  (46.1) 42.0  (39.5) 38.7  (70.0) 30.9  (44.4)
4.Secondary Outcome
Title Percentage Change in WOMAC Pain Subscale Score From Baseline to Intervening Visits (Visits 2-4)
Hide Description Percentage of difference in WOMAC Pain Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales, using a 100mm visual analog scale ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.
Time Frame Week 0, week 3, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)
Arm/Group Title 1: Tramadol Once A Day 100mg 2: Tramadol Once A Day 200mg 3: Tramadol Once A Day 300mg 4: Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 103 107 105 224
Mean (Standard Deviation)
Unit of Measure: Percentage difference in WOMAC Pain
Week 0 (Visit 2) 30.0  (41.1) 34.5  (41.5) 33.0  (44.6) 19.4  (36.5)
Week 3 (Visit 3) 56.4  (39.2) 46.4  (37.7) 51.7  (41.9) 37.8  (40.0)
Week 6 (Visit 4) 58.2  (39.3) 48.8  (39.8) 57.2  (37.6) 44.7  (41.8)
5.Secondary Outcome
Title Percentage Change in WOMAC Physical Function Subscale Score From Baseline to Intervening Visits (Visits 2-4)
Hide Description Percentage of difference in WOMAC Physical Function Subscale score between baseline and intervening visits 2-4. The WOMAC scale is a 24-item questionnaire divided in 3 subscales. The WOMAC Physical Function Subscale comprises 17 questions each rated on a 100mm visual analog scale (VAS) ranging from no difficulty (0mm) to extreme difficulty (100mm).
Time Frame Week 0, week 3, week 6
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)
Arm/Group Title 1: Tramadol Once A Day 100mg 2: Tramadol Once A Day 200mg 3: Tramadol Once A Day 300mg 4: Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 103 107 105 224
Mean (Standard Deviation)
Unit of Measure: Percentage difference in WOMAC Physical
Week 0 (Visit 2) 32.0  (36.8) 29.8  (35.6) 34.5  (35.9) 17.2  (36.0)
Week 3 (Visit 3) 54.9  (37.9) 43.5  (37.1) 50.4  (36.8) 34.4  (38.6)
Week 6 (Visit 4) 56.2  (37.6) 44.2  (40.0) 53.5  (58.9) 39.5  (41.3)
6.Secondary Outcome
Title Multiple Dose Effect Using 24-hour VAS Pain Questionnaire
Hide Description Patients rated their knee pain by marking a 100mm Visual Analogue Scale, ranging from no pain (0mm) to extreme pain (100mm).
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale). Missing Values at Last Visit Imputed by Individual Last Post Baseline Value.
Arm/Group Title 1: Tramadol Once A Day 100mg 2: Tramadol Once A Day 200mg 3: Tramadol Once A Day 300mg 4: Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 103 107 105 224
Mean (Standard Deviation)
Unit of Measure: mm
Lunchtime (last individual visit) 35.1  (29.4) 32.0  (25.2) 34.4  (28.6) 38.9  (30.5)
Bed time (last individual visit) 37.0  (31.4) 34.3  (26.0) 34.7  (29.9) 41.9  (32.6)
Before next morning dose (last individual visit) 35.9  (31.3) 34.3  (27.6) 34.8  (29.1) 40.6  (31.5)
7.Secondary Outcome
Title Investigator Global Rating of Pain Relief
Hide Description The Investigator Global Rating of Pain is a 3-item Likert-scale to answer the following question: "How do you rate this patient’s overall pain relief with the drug?" with 3 possible answers: "very effective", "effective", or "ineffective".
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed using the full analysis population (All randomized patients who received at least one dose of the assigned study medication and had at least one post Baseline assessment of any functional scale)
Arm/Group Title 1: Tramadol Once A Day 100mg 2: Tramadol Once A Day 200mg 3: Tramadol Once A Day 300mg 4: Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 103 107 105 224
Measure Type: Number
Unit of Measure: participants
Very effective 20 26 26 26
Effective 46 53 61 102
Ineffective 35 28 17 95
8.Secondary Outcome
Title Dropout Rate
Hide Description Reasons for withdrawal from the trial were collected
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: all randomized patients who received at least one dose of the assigned study medication.
Arm/Group Title 1: Tramadol Once A Day 100mg 2: Tramadol Once A Day 200mg 3: Tramadol Once A Day 300mg 4: Placebo
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 106 111 108 227
Measure Type: Number
Unit of Measure: percentage of participants
Lack of efficacy 19.8 9.9 10.2 20.7
Patient request 3.8 7.2 9.3 4.0
Investigator initiated discontinuation 5.7 6.3 1.9 8.4
Adverse events 12.3 18.0 32.4 7.5
Death 0 0 0 0.4
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 1: Tramadol Once A Day 100mg 2: Tramadol Once A Day 200mg 3: Tramadol Once A Day 300mg 4: Placebo
Hide Arm/Group Description [Not Specified] [Not Specified] [Not Specified] [Not Specified]
All-Cause Mortality
1: Tramadol Once A Day 100mg 2: Tramadol Once A Day 200mg 3: Tramadol Once A Day 300mg 4: Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
1: Tramadol Once A Day 100mg 2: Tramadol Once A Day 200mg 3: Tramadol Once A Day 300mg 4: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1      0      1      2    
Cardiac disorders         
Myocardial infarction *  0/106 (0.00%)  0 0/111 (0.00%)  0 0/108 (0.00%)  0 1/227 (0.44%)  1
Gastrointestinal disorders         
Small intestinal obstruction Not Otherwise Specified (NOS) *  1/106 (0.94%)  1 0/111 (0.00%)  0 0/108 (0.00%)  0 0/227 (0.00%)  0
Gastritis Not Otherwise Specified (NOS) *  0/106 (0.00%)  0 0/111 (0.00%)  0 1/108 (0.93%)  1 0/227 (0.00%)  0
Abdominal pain lower *  0/106 (0.00%)  0 0/111 (0.00%)  0 0/108 (0.00%)  0 1/227 (0.44%)  1
*
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 100mg 2: Tramadol Once A Day 200mg 3: Tramadol Once A Day 300mg 4: Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30      55      56      37    
Gastrointestinal disorders         
Constipation *  11/106 (10.38%)  11 16/111 (14.41%)  22 10/108 (9.26%)  13 3/227 (1.32%)  3
Nausea *  12/106 (11.32%)  14 22/111 (19.82%)  34 28/108 (25.93%)  36 13/227 (5.73%)  18
Nervous system disorders         
Dizziness *  11/106 (10.38%)  11 10/111 (9.01%)  13 20/108 (18.52%)  21 9/227 (3.96%)  13
Somnolence *  9/106 (8.49%)  11 17/111 (15.32%)  19 13/108 (12.04%)  13 2/227 (0.88%)  2
Headache *  6/106 (5.66%)  8 10/111 (9.01%)  15 6/108 (5.56%)  6 18/227 (7.93%)  21
*
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: NCT00852917     History of Changes
Other Study ID Numbers: MDT3-003
First Submitted: January 29, 2009
First Posted: February 27, 2009
Results First Submitted: April 8, 2009
Results First Posted: June 2, 2009
Last Update Posted: April 30, 2012