Trial Outcomes & Findings for 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 (NCT NCT00911742)

NCT ID: NCT00911742

Last Updated: 2012-04-27

Results Overview

Area under the plasma concentration versus time curve to the last measured concentration. h=hour

• Recruitment status: COMPLETED
• Study phase: PHASE1
• Target enrollment: 26 participants
• Primary outcome timeframe: 48 hours
• Results posted on: 2012-04-27

Participant Flow

Participant milestones

Measure	Tramadol Contramid Once A Day 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	Zytram (R) 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
Treatment Phase I STARTED	13	13
Treatment Phase I COMPLETED	13	13
Treatment Phase I NOT COMPLETED	0	0
Treatment Phase II STARTED	13	13
Treatment Phase II COMPLETED	13	13
Treatment Phase II NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Tramadol Contramid Once A Day n=13 Participants 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	Zytram (R) n=13 Participants 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 n=26 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	13 Participants n=5 Participants	13 Participants n=7 Participants	26.0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0.0 Participants n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	8 Participants n=7 Participants	13.0 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	5 Participants n=7 Participants	13.0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 hours

Area under the plasma concentration versus time curve to the last measured concentration.

h=hour

Outcome measures

Measure	Tramadol Contramid Once A Day n=26 Participants 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	Zytram (R) n=26 Participants 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
AUC(0-t)	5886 ng.h/mL Standard Deviation 1843	4761 ng.h/mL Standard Deviation 1623

PRIMARY outcome

Timeframe: 48 hours

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

Outcome measures

Measure	Tramadol Contramid Once A Day n=26 Participants 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	Zytram (R) n=26 Participants 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
AUC (0-∞)	6112 ng.h/mL Standard Deviation 2078	5638 ng.h/mL Standard Deviation 2274

PRIMARY outcome

Timeframe: 48 hours

Maximum plasma concentration

Outcome measures

Measure	Tramadol Contramid Once A Day n=26 Participants 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	Zytram (R) n=26 Participants 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
Cmax	270 ng/mL Standard Deviation 96	219 ng/mL Standard Deviation 50

SECONDARY outcome

Timeframe: 48 hours

Apparent terminal elimination half-life

Outcome measures

Measure	Tramadol Contramid Once A Day n=26 Participants 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	Zytram (R) n=26 Participants 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
t1/2	7.41 hours Standard Deviation 2.15	14.92 hours Standard Deviation 7.11

SECONDARY outcome

Timeframe: 48 hours

Time to maximum plasma concentration

Outcome measures

Measure	Tramadol Contramid Once A Day n=26 Participants 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	Zytram (R) n=26 Participants 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
Tmax	9.0 hours Interval 2.0 to 16.0	4.5 hours Interval 2.0 to 12.0

Adverse Events

Tramadol Contramid Once A Day

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Zytram (R)

Serious events: 0 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tramadol Contramid Once A Day n=26 participants at risk 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	Zytram (R) n=26 participants at risk 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
General disorders Headache	3.8% 1/26	7.7% 2/26
Psychiatric disorders Somnolence	7.7% 2/26	7.7% 2/26
Nervous system disorders Dizziness	23.1% 6/26	15.4% 4/26
Gastrointestinal disorders nausea	3.8% 1/26	7.7% 2/26
Gastrointestinal disorders Vomiting	7.7% 2/26	3.8% 1/26

Additional Information

Director of Regulatory Affairs

Labopharm Inc.

Phone: 1 450 686 1017

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER