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An Open-Label Long-term Safety Study of Tramadol HCl OAD (Once A Day) 300 mg in the Treatment of Pain Due to Osteoarthritis of the Knee

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ClinicalTrials.gov Identifier: NCT00833911
Recruitment Status : Completed
First Posted : February 2, 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 Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Osteoarthritis, Knee
Intervention Drug: Tramadol Once A Day
Enrollment 392
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 300 mg Tramadol HCl OAD
Hide Arm/Group Description [Not Specified]
Period Title: Titration
Started 392
Completed 371
Not Completed 21
Reason Not Completed
Adverse Event             18
Withdrawal by Subject             3
Period Title: Maintenance Phase I
Started 371
Completed 273
Not Completed 98
Reason Not Completed
Adverse Event             73
Withdrawal by Subject             11
Physician Decision             10
Lack of Efficacy             4
Period Title: Maintenance Phase II
Started 176 [1]
Completed 166
Not Completed 10
Reason Not Completed
Adverse Event             6
Physician Decision             2
Withdrawal by Subject             1
Lack of Efficacy             1
[1]
97 patients chose not to continue into Maintenance Phase II
Arm/Group Title 300 mg Tramadol HCl OAD
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 392
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 392 participants
<=18 years
0
   0.0%
Between 18 and 65 years
229
  58.4%
>=65 years
163
  41.6%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 392 participants
61.4  (8.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 392 participants
Female
333
  84.9%
Male
59
  15.1%
1.Primary Outcome
Title Number of Patients Having Experienced an Adverse Event During the 6-12 Month Open-Label Safety Participation
Hide Description Spontaneous reports of adverse events were recorded for the entire study population, the 6-months safety population and the 12-months safety population
Time Frame 6 months and 12 months
Hide Outcome Measure Data
Hide Analysis Population Description

All patients having taken 1 dose of 300 mg Tramadol HCl OAD at a minimum are being assessed for adverse event occurence for up to 12 months.

6-months safety: patients who completed at least 175 days on treatment.

12-months safety: patients who completed at least 350 days on treatment.

Arm/Group Title All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum 6-months Safety 12-months Safety
Hide Arm/Group Description:
All patients in the study who took at least one dose of 300 mg Tramadol HCl OAD. Overall time frame for this population is 0-12 months.
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 392 275 168
Measure Type: Number
Unit of Measure: participants
346 188 121
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum 6-months Safety 12-months Safety
Hide Arm/Group Description All patients in the study who took at least one dose of 300 mg Tramadol HCl OAD. Overall time frame for this population is 0-12 months. [Not Specified] [Not Specified]
All-Cause Mortality
All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum 6-months Safety 12-months Safety
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum 6-months Safety 12-months Safety
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   9/392 (2.30%)      1/275 (0.36%)      0/168 (0.00%)    
Cardiac disorders       
Acute pulmonary oedema *  1/392 (0.26%)  1 0/275 (0.00%)  0 0/168 (0.00%)  0
Gastrointestinal disorders       
Constipation *  1/392 (0.26%)  1 0/275 (0.00%)  0 0/168 (0.00%)  0
Pancreatitis chronic *  1/392 (0.26%)  1 0/275 (0.00%)  0 0/168 (0.00%)  0
Hepatobiliary disorders       
Cholecystitis, Not Otherwise Specified (NOS) *  1/392 (0.26%)  1 0/275 (0.00%)  0 0/168 (0.00%)  0
Injury, poisoning and procedural complications       
Femoral neck fracture *  1/392 (0.26%)  1 0/275 (0.00%)  0 0/168 (0.00%)  0
Metabolism and nutrition disorders       
Diabetes mellitus, Not Otherwise Specified (NOS) *  1/392 (0.26%)  1 0/275 (0.00%)  0 0/168 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain *  1/392 (0.26%)  1 1/275 (0.36%)  1 0/168 (0.00%)  0
Osteoarthritis aggravated *  1/392 (0.26%)  1 0/275 (0.00%)  0 0/168 (0.00%)  0
Nervous system disorders       
Paresis *  1/392 (0.26%)  1 0/275 (0.00%)  0 0/168 (0.00%)  0
Surgical and medical procedures       
Cholecystectomy *  1/392 (0.26%)  1 0/275 (0.00%)  0 0/168 (0.00%)  0
Vascular disorders       
Cerebrovascular accident *  1/392 (0.26%)  1 0/275 (0.00%)  0 0/168 (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%
All Patients With 1 Dose of 300 mg Tramadol HCl OAD Minimum 6-months Safety 12-months Safety
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   321/392 (81.89%)      169/275 (61.45%)      101/168 (60.12%)    
Ear and labyrinth disorders       
Vertigo *  31/392 (7.91%)  38 8/275 (2.91%)  9 8/168 (4.76%)  11
Gastrointestinal disorders       
Constipation *  121/392 (30.87%)  155 74/275 (26.91%)  86 40/168 (23.81%)  51
Nausea *  159/392 (40.56%)  233 62/275 (22.55%)  92 42/168 (25.00%)  67
Vomiting *  55/392 (14.03%)  67 17/275 (6.18%)  24 13/168 (7.74%)  17
General disorders       
Fatigue *  19/392 (4.85%)  27 15/275 (5.45%)  20 4/168 (2.38%)  4
Infections and infestations       
Influenza *  19/392 (4.85%)  22 18/275 (6.55%)  20 7/168 (4.17%)  8
Nasopharyngitis *  22/392 (5.61%)  25 16/275 (5.82%)  17 13/168 (7.74%)  15
Urinary tract infection *  20/392 (5.10%)  20 7/275 (2.55%)  7 10/168 (5.95%)  10
Investigations       
Weight decreased *  29/392 (7.40%)  29 16/275 (5.82%)  16 11/168 (6.55%)  11
Metabolism and nutrition disorders       
Anorexia *  21/392 (5.36%)  22 15/275 (5.45%)  16 8/168 (4.76%)  8
Nervous system disorders       
Dizziness *  106/392 (27.04%)  134 30/275 (10.91%)  42 22/168 (13.10%)  36
Headache *  62/392 (15.82%)  80 25/275 (9.09%)  31 28/168 (16.67%)  42
Somnolence *  99/392 (25.26%)  116 29/275 (10.55%)  36 13/168 (7.74%)  13
Skin and subcutaneous tissue disorders       
Pruritus *  21/392 (5.36%)  23 4/275 (1.45%)  4 1/168 (0.60%)  1
Sweating increased *  23/392 (5.87%)  25 18/275 (6.55%)  20 2/168 (1.19%)  3
Vascular disorders       
Hypertension *  15/392 (3.83%)  15 5/275 (1.82%)  5 10/168 (5.95%)  10
*
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: NCT00833911     History of Changes
Other Study ID Numbers: MDT3-004
First Submitted: January 29, 2009
First Posted: February 2, 2009
Results First Submitted: April 8, 2009
Results First Posted: June 2, 2009
Last Update Posted: April 30, 2012