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Trial record 87 of 456 for:    TRAMADOL

Comparative Bioavailability Between Two Tramadol Formulations: Study of the Better Controlled Release of a New 200 mg Once A Day (OAD) Formulation Versus Zytram® 200 mg

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ClinicalTrials.gov Identifier: NCT00911742
Recruitment Status : Completed
First Posted : June 2, 2009
Results First Posted : June 2, 2009
Last Update Posted : April 27, 2012
Sponsor:
Information provided by:
Labopharm Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Pain
Interventions Drug: Tramadol Contramid OAD
Drug: Zytram
Enrollment 26
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tramadol Contramid Once A Day Zytram (R)
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Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.

OAD: Once-A-Day

Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.

OAD: Once-A-Day

Period Title: Treatment Phase I
Started 13 13
Completed 13 13
Not Completed 0 0
Period Title: Treatment Phase II
Started 13 13
Completed 13 13
Not Completed 0 0
Arm/Group Title Tramadol Contramid Once A Day Zytram (R) Total
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Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.

OAD: Once-A-Day

Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.

OAD: Once-A-Day

Total of all reporting groups
Overall Number of Baseline Participants 13 13 26
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
<=18 years
0
   0.0%
0
   0.0%
0.0
Between 18 and 65 years
13
 100.0%
13
 100.0%
26.0
>=65 years
0
   0.0%
0
   0.0%
0.0
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 13 participants 13 participants 26 participants
Female
5
  38.5%
8
  61.5%
13.0
Male
8
  61.5%
5
  38.5%
13.0
1.Primary Outcome
Title AUC(0-t)
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Area under the plasma concentration versus time curve to the last measured concentration.

h=hour

Time Frame 48 hours
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Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tramadol Contramid Once A Day Zytram (R)
Hide Arm/Group Description:

Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.

OAD: Once-A-Day

Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.

OAD: Once-A-Day

Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
5886  (1843) 4761  (1623)
2.Primary Outcome
Title AUC (0-∞)
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The area under the plasma concentration curve was estimated by extrapolating to infinity AUC0–t. The extrapolation to infinity was done by regression with the last log-transformed data to estimate the terminal area by means of the line that maximized R’2 (coefficient of determination). The units are ng.h/mL.

h=hours

Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tramadol Contramid Once A Day Zytram (R)
Hide Arm/Group Description:

Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.

OAD: Once-A-Day

Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.

OAD: Once-A-Day

Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: ng.h/mL
6112  (2078) 5638  (2274)
3.Primary Outcome
Title Cmax
Hide Description Maximum plasma concentration
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tramadol Contramid Once A Day Zytram (R)
Hide Arm/Group Description:

Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.

OAD: Once-A-Day

Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.

OAD: Once-A-Day

Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: ng/mL
270  (96) 219  (50)
4.Secondary Outcome
Title t1/2
Hide Description Apparent terminal elimination half-life
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tramadol Contramid Once A Day Zytram (R)
Hide Arm/Group Description:

Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.

OAD: Once-A-Day

Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.

OAD: Once-A-Day

Overall Number of Participants Analyzed 26 26
Mean (Standard Deviation)
Unit of Measure: hours
7.41  (2.15) 14.92  (7.11)
5.Secondary Outcome
Title Tmax
Hide Description Time to maximum plasma concentration
Time Frame 48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tramadol Contramid Once A Day Zytram (R)
Hide Arm/Group Description:

Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.

OAD: Once-A-Day

Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.

OAD: Once-A-Day

Overall Number of Participants Analyzed 26 26
Median (Full Range)
Unit of Measure: hours
9.0
(2 to 16)
4.5
(2 to 12)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tramadol Contramid Once A Day Zytram (R)
Hide Arm/Group Description

Single oral administration of 1x200mg Tramadol OAD tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.

OAD: Once-A-Day

Single oral administration of 1x200mg Zytram tablet according to randomization schedule. There were 2 treatment sequences, each separated by at least one week wash-out period.

OAD: Once-A-Day

All-Cause Mortality
Tramadol Contramid Once A Day Zytram (R)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Tramadol Contramid Once A Day Zytram (R)
Affected / at Risk (%) Affected / at Risk (%)
Total   0/26 (0.00%)   0/26 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Tramadol Contramid Once A Day Zytram (R)
Affected / at Risk (%) Affected / at Risk (%)
Total   8/26 (30.77%)   9/26 (34.62%) 
Gastrointestinal disorders     
nausea *  1/26 (3.85%)  2/26 (7.69%) 
Vomiting *  2/26 (7.69%)  1/26 (3.85%) 
General disorders     
Headache *  1/26 (3.85%)  2/26 (7.69%) 
Nervous system disorders     
Dizziness *  6/26 (23.08%)  4/26 (15.38%) 
Psychiatric disorders     
Somnolence *  2/26 (7.69%)  2/26 (7.69%) 
*
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.
The investigator must agree to maintain the confidentiality of the study at all times, and he cannot reveal any information coming from the protocol, the study results or any documentation related to the study, without permission of the sponsor. Any publication of the results, in whole or in part will require the permission of the sponsor.
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: Vice-President Regulatory Affairs, Labopharm Inc.
ClinicalTrials.gov Identifier: NCT00911742     History of Changes
Other Study ID Numbers: MDT1-012
First Submitted: April 8, 2009
First Posted: June 2, 2009
Results First Submitted: April 8, 2009
Results First Posted: June 2, 2009
Last Update Posted: April 27, 2012