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Trial record 29 of 10799 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

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: NCT00832416
Recruitment Status : Completed
First Posted : January 30, 2009
Results First Posted : August 3, 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, Knee
Interventions Drug: Tramadol Once A Day
Drug: Placebo
Enrollment 565
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 110 113 115 227
Completed 64 60 54 144
Not Completed 46 53 61 83
Reason Not Completed
Lack of Efficacy             17             15             13             52
Withdrawal by Subject             5             7             2             10
Physician Decision             2             12             5             10
Administrative             0             0             0             1
Adverse Event             21             19             41             10
Death             1             0             0             0
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 110 113 115 227 565
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 113 participants 115 participants 227 participants 565 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0.0
Between 18 and 65 years
69
  62.7%
77
  68.1%
66
  57.4%
139
  61.2%
351.0
>=65 years
41
  37.3%
36
  31.9%
49
  42.6%
88
  38.8%
214.0
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants 113 participants 115 participants 227 participants 565 participants
59.8  (9.0) 59.8  (8.4) 61.0  (9.6) 60.6  (9.6) 60.4  (9.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants 113 participants 115 participants 227 participants 565 participants
Female
65
  59.1%
64
  56.6%
72
  62.6%
140
  61.7%
341.0
Male
45
  40.9%
49
  43.4%
43
  37.4%
87
  38.3%
224.0
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). Last Individual 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 108 109 113 223
Measure Type: Number
Unit of Measure: participants
Very effective 19 16 26 29
Effective 50 56 56 94
Ineffective 39 37 31 100
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 ranging from no pain (0mm) to extreme pain (100mm). The WOMAC Pain Subscale results from the sum of 5 questions.
Time Frame Baseline to week 12
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 109 110 113 226
Mean (Standard Deviation)
Unit of Measure: Percentage difference
36.3  (45.3) 36.6  (40.9) 41.0  (44.5) 38.0  (41.7)
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 pain (0mm) to extreme pain (100mm). The WOMAC Physical Function subscale results from the sum of 17 questions.
Time Frame Baseline to week 12
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 109 110 113 226
Mean (Standard Deviation)
Unit of Measure: Percentage difference
31.9  (46.0) 37.0  (39.3) 37.3  (41.7) 33.7  (44.3)
4.Secondary Outcome
Title Percentage Difference 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). 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 109 110 113 226
Mean (Standard Deviation)
Unit of Measure: Percentage difference
Week 0 (Visit 2) 26.7  (36.9) 29.0  (33.4) 33.1  (41.4) 20.4  (35.8)
Week 3 (Visit 3) 35.2  (40.9) 36.0  (40.3) 42.3  (40.6) 35.1  (39.4)
Week 6 (Visit 4) 36.3  (40.9) 36.4  (39.5) 47.7  (42.2) 41.3  (39.9)
5.Secondary Outcome
Title Percentage Difference 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 pain (0mm) to extreme pain (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). 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 109 110 113 226
Mean (Standard Deviation)
Unit of Measure: Percentage difference
Week 0 (Visit 2) 23.4  (37.1) 26.4  (30.9) 29.3  (37.9) 18.5  (37.7)
Week 3 (Visit 3) 33.3  (40.7) 36.5  (34.4) 41.0  (39.7) 33.7  (38.2)
Week 6 (Visit 4) 33.5  (39.8) 37.0  (36.8) 47.7  (43.8) 38.3  (37.8)
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 109 110 113 226
Mean (Standard Deviation)
Unit of Measure: mm
Pain at lunchtime (last individual visit) 40.5  (29.9) 38.2  (29.6) 36.6  (29.4) 38.5  (29.5)
Pain at bed time (last individual visit) 41.2  (30.7) 41.1  (29.9) 37.3  (30.2) 39.7  (29.4)
Pain Before next morning dose (last individ visit) 41.1  (30.1) 42.0  (29.5) 35.5  (29.3) 38.5  (29.8)
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). Last Individual 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 108 109 111 223
Measure Type: Number
Unit of Measure: participants
Very effective 20 14 22 29
Effective 49 58 57 98
Ineffective 39 37 32 96
8.Secondary Outcome
Title Percentage of Participants Who Dropped Out From Trial by Dropout Reason
Hide Description Reasons for withdrawal from the trial were collected and the percentage of participants who dropped out from trial were calculated by dropout reason
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 110 113 115 227
Measure Type: Number
Unit of Measure: percentage of participants
Lack of efficacy 15.5 13.3 11.3 22.9
Patient request 4.5 6.2 1.7 4.4
Investigator initiated discontinuation 1.8 10.6 4.3 4.4
Administrative 0 0 0 0.4
Adverse event 19.1 16.8 35.7 4.4
Death 0.9 0 0 0
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   2/110 (1.82%)      1/113 (0.88%)      4/115 (3.48%)      3/227 (1.32%)    
Cardiac disorders         
Acute myocardial infarction *  1/110 (0.91%)  1 0/113 (0.00%)  0 0/115 (0.00%)  0 0/227 (0.00%)  0
Gastrointestinal disorders         
Pancreatitis aggravated *  0/110 (0.00%)  0 0/113 (0.00%)  0 1/115 (0.87%)  1 0/227 (0.00%)  0
Faecal impaction *  0/110 (0.00%)  0 0/113 (0.00%)  0 1/115 (0.87%)  1 0/227 (0.00%)  0
Gastroenteritis viral NOS *  0/110 (0.00%)  0 0/113 (0.00%)  0 0/115 (0.00%)  0 1/227 (0.44%)  1
Rectal prolapse *  0/110 (0.00%)  0 0/113 (0.00%)  0 0/115 (0.00%)  0 1/227 (0.44%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Breast cancer invasive NOS *  0/110 (0.00%)  0 1/113 (0.88%)  1 0/115 (0.00%)  0 0/227 (0.00%)  0
Thyroid neoplasm NOS *  0/110 (0.00%)  0 0/113 (0.00%)  0 1/115 (0.87%)  1 0/227 (0.00%)  0
Psychiatric disorders         
Bipolar disorder NEC *  1/110 (0.91%)  1 0/113 (0.00%)  0 0/115 (0.00%)  0 0/227 (0.00%)  0
Vascular disorders         
Deep venous thrombosis NOS *  1/110 (0.91%)  1 0/113 (0.00%)  0 0/115 (0.00%)  0 0/227 (0.00%)  0
Aortic aneurysm *  0/110 (0.00%)  0 0/113 (0.00%)  0 1/115 (0.87%)  1 0/227 (0.00%)  0
Venous thrombosis NOS limb *  0/110 (0.00%)  0 0/113 (0.00%)  0 0/115 (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   31/110 (28.18%)      49/113 (43.36%)      57/115 (49.57%)      38/227 (16.74%)    
Gastrointestinal disorders         
Constipation *  10/110 (9.09%)  10 17/113 (15.04%)  20 18/115 (15.65%)  20 15/227 (6.61%)  17
Vomiting *  4/110 (3.64%)  4 8/113 (7.08%)  9 14/115 (12.17%)  18 2/227 (0.88%)  2
Nervous system disorders         
Dizziness *  7/110 (6.36%)  7 20/113 (17.70%)  20 25/115 (21.74%)  33 5/227 (2.20%)  6
Nausea *  17/110 (15.45%)  18 25/113 (22.12%)  29 32/115 (27.83%)  39 14/227 (6.17%)  14
Headache *  7/110 (6.36%)  8 6/113 (5.31%)  12 10/115 (8.70%)  12 15/227 (6.61%)  17
*
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: NCT00832416     History of Changes
Other Study ID Numbers: MDT3-002
First Submitted: January 29, 2009
First Posted: January 30, 2009
Results First Submitted: April 8, 2009
Results First Posted: August 3, 2009
Last Update Posted: April 30, 2012