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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Labopharm Inc.
ClinicalTrials.gov Identifier:
NCT00952068
First received: April 16, 2009
Last updated: April 25, 2012
Last verified: April 2012
History of Changes
Results First Received: April 16, 2009  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Acute Low Back Pain
Intervention: Drug: Tramadol Contramid® OAD 200mg

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Tramadol Contramid® Once-A-Day (OAD) Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)

Participant Flow:   Overall Study
    Tramadol Contramid® Once-A-Day (OAD)  
STARTED     47  
COMPLETED     40  
NOT COMPLETED     7  
Adverse Event                 3  
Withdrawal by Subject                 4  



  Baseline Characteristics
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Reporting Groups
  Description
Tramadol Contramid® Once-A-Day (OAD) Single dose 200 mg of Tramadol Contramid® Once-A-Day (OAD)

Baseline Measures
    Tramadol Contramid® Once-A-Day (OAD)  
Number of Participants  
[units: participants]
 		  47  
Age  
[units: participants]
 		 
<=18 years     0  
Between 18 and 65 years     26  
>=65 years     21  
Age  
[units: years]
Mean ± Standard Deviation 		  61.2  ± 10.2  
Gender  
[units: participants]
 		 
Female     37  
Male     10  
Region of Enrollment  
[units: participants]
 		 
Romania     47  



  Outcome Measures
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1.  Primary:   Time to Onset of Perceptible Pain Relief   [ Time Frame: 6 hours ]
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2.  Secondary:   Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose   [ Time Frame: Baseline, 3 hours post-dose, 6 hours post-dose, time of onset of perceptible pain relief ]
  Show Outcome Measure 2

3.  Secondary:   Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose   [ Time Frame: 3 hours post-dose, 6 hours post-dose, at time of onset of perceptible pain relief ]
  Show Outcome Measure 3

4.  Secondary:   Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose   [ Time Frame: Baseline, time of onset of perceptible pain relief, 3 hours post-dose, 6 hours post-dose ]
  Show Outcome Measure 4

5.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 6 hours ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:  
Name/Title: Director of Regulatory Affairs
Organization: Labopharm Inc.
phone: 1 450 686 1017


Publications of Results:


Responsible Party: Labopharm Inc.
ClinicalTrials.gov Identifier: NCT00952068     History of Changes
Other Study ID Numbers: MDT2-002
Study First Received: April 16, 2009
Results First Received: April 16, 2009
Last Updated: April 25, 2012
Health Authority: Romania: National Medicines Agency