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A Pharmacodynamic/Pharmacokinetic Study to Determine the Onset of Analgesic Effect and Plasma Levels of Tramadol in Patients With Acute Low Back Pain Receiving a Single 200 mg Dose of Tramadol Contramid® Once-a-Day

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ClinicalTrials.gov Identifier: NCT00952068
Recruitment Status : Completed
First Posted : August 4, 2009
Results First Posted : August 4, 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 Acute Low Back Pain
Intervention Drug: Tramadol Contramid® OAD 200mg
Enrollment 47
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tramadol Contramid® Once-A-Day (OAD)
Hide Arm/Group Description Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
Period Title: Overall Study
Started 47
Completed 40
Not Completed 7
Reason Not Completed
Adverse Event             3
Withdrawal by Subject             4
Arm/Group Title Tramadol Contramid® Once-A-Day (OAD)
Hide Arm/Group Description Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
Overall Number of Baseline Participants 47
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
<=18 years
0
   0.0%
Between 18 and 65 years
26
  55.3%
>=65 years
21
  44.7%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 47 participants
61.2  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 47 participants
Female
37
  78.7%
Male
10
  21.3%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Romania Number Analyzed 47 participants
47
1.Primary Outcome
Title Time to Onset of Perceptible Pain Relief
Hide Description Kaplan-Meier estimates of time to perceptible pain relief. Patients who discontinued or completed the study without perceptible pain relief were censored at the time point of their last pain intensity score. A confidence interval for the median survival time was calculated.
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.
Arm/Group Title Tramadol Contramid® Once-A-Day (OAD)
Hide Arm/Group Description:
Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
Overall Number of Participants Analyzed 46
Median (95% Confidence Interval)
Unit of Measure: minutes
47
(40 to 51)
2.Secondary Outcome
Title Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose
Hide Description Pain intensity rating at baseline, time of onset of perceptible pain relief, 3 hours and 6 hours post-dose or if the patient discontinued earlier. "What is your current level of pain intensity?" 0=none, 1=mild, 2=moderate, 3=severe. Missing data were imputed using Last Observation Carried Forward (LOCF).
Time Frame Baseline, 3 hours post-dose, 6 hours post-dose, time of onset of perceptible pain relief
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.
Arm/Group Title Tramadol Contramid® Once-A-Day (OAD)
Hide Arm/Group Description:
Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: participants
Baseline, moderate pain 34
Baseline, severe pain 12
Onset of perceptible pain relief, no pain 4
Onset of perceptible pain relief, mild pain 23
Onset of perceptible pain relief, moderate pain 19
3 hours post-dose, no pain 12
3 hours post-dose, mild pain 25
3 hours post-dose, moderate pain 9
6 hours post-dose, no pain 24
6 hours post-dose, mild pain 20
6 hours post-dose, moderate pain 2
3.Secondary Outcome
Title Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose
Hide Description Pain relief rating at time of onset of perceptible pain relief, 3 hours and 6 hours post-dose or if the patient discontinued earlier. " How would you rate the pain relief the study medication has given you?" ranging from 0=none to 4=complete relief. Missing data were imputed using Last Observation Carried Forward (LOCF).
Time Frame 3 hours post-dose, 6 hours post-dose, at time of onset of perceptible pain relief
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.
Arm/Group Title Tramadol Contramid® Once-A-Day (OAD)
Hide Arm/Group Description:
Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
Overall Number of Participants Analyzed 46
Measure Type: Number
Unit of Measure: participants
Onset of perceptible pain relief, no pain relief 1
Onset of perceptible pain relief, a little relief 16
Onset of perceptible pain relief, moderate relief 9
Onset of perceptible pain relief, a lot of relief 16
Onset of perceptible pain relief, complete relief 4
3 hours post-dose, no pain relief 2
3 hours post-dose, a little relief 3
3 hours post-dose, moderate relief 12
3 hours post-dose, a lot of relief 17
3 hours post-dose, complete relief 12
6 hours post-dose, no pain relief 1
6 hours post-dose, a little relief 2
6 hours post-dose, moderate relief 1
6 hours post-dose, a lot of relief 18
6 hours post-dose, complete relief 24
4.Secondary Outcome
Title Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose
Hide Description PK samples were drawn at the end of the Screening Phase, at the onset of perceptible pain relief, at 3 hours and at 6 hours post-dose or if the patient discontinues early. PK samples were always drawn after the completion of the patient ratings of pain relief and of pain intensity scales. They were processed in a central laboratory and the plasma levels of tramadol were collected.
Time Frame Baseline, time of onset of perceptible pain relief, 3 hours post-dose, 6 hours post-dose
Hide Outcome Measure Data
Hide Analysis Population Description
Full analysis population: includes all patients who received the dose of study medication and who had at least one pharmacodynamic assessment during the dosing phase.
Arm/Group Title Tramadol Contramid® Once-A-Day (OAD)
Hide Arm/Group Description:
Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
Overall Number of Participants Analyzed 46
Mean (Standard Deviation)
Unit of Measure: ng/ml
0 hour 5.17  (1.55)
Onset of perceptible pain relief 56.10  (37.61)
3 hours post-dose 176.34  (48.68)
6 hours post-dose 187.98  (67.03)
5.Secondary Outcome
Title Number of Participants With Adverse Events
Hide Description All adverse events reported during treatment with study drug were considered and reported as treatment emergent adverse events (TEAE) whether or not medication for this adverse event was required by the participant and were summarized in the same table.
Time Frame 6 hours
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population: includes all patients who received the dose of the study medication.
Arm/Group Title Tramadol Contramid® Once-A-Day (OAD)
Hide Arm/Group Description:
Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
Overall Number of Participants Analyzed 47
Measure Type: Number
Unit of Measure: participants
Patients with at least one TEAE 23
Patients with at least one severe TEAE 5
Patients with at least one SAE 0
Patients with at least 1 possibly drug related AE 23
Patients with at least one TEAE requiring therapy 3
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tramadol Contramid® Once-A-Day (OAD)
Hide Arm/Group Description Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)
All-Cause Mortality
Tramadol Contramid® Once-A-Day (OAD)
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Tramadol Contramid® Once-A-Day (OAD)
Affected / at Risk (%) # Events
Total   0/47 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Tramadol Contramid® Once-A-Day (OAD)
Affected / at Risk (%) # Events
Total   23/47 (48.94%)    
Cardiac disorders   
Bradychardia NOS (Not Otherwise Specified) *  2/47 (4.26%)  2
Gastrointestinal disorders   
Nausea *  8/47 (17.02%)  12
Vomiting NOS (Not Otherwise Specified) *  5/47 (10.64%)  10
Dry mouth *  3/47 (6.38%)  4
Nervous system disorders   
Somnolence *  14/47 (29.79%)  15
Dizziness *  8/47 (17.02%)  12
Headache NOS (Not Otherwise Specified) *  4/47 (8.51%)  4
Syncope *  1/47 (2.13%)  1
Skin and subcutaneous tissue disorders   
Sweating increased *  2/47 (4.26%)  2
*
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
Layout table for Results Point of Contact information
Name/Title: Director of Regulatory Affairs
Organization: Labopharm Inc.
Phone: 1 450 686 1017
Layout table for additonal information
Responsible Party: Labopharm Inc.
ClinicalTrials.gov Identifier: NCT00952068     History of Changes
Other Study ID Numbers: MDT2-002
First Submitted: April 16, 2009
First Posted: August 4, 2009
Results First Submitted: April 16, 2009
Results First Posted: August 4, 2009
Last Update Posted: April 30, 2012