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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:
ClinicalTrials.gov Identifier:
NCT00952068
First Posted: August 4, 2009
Last Update Posted: April 30, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Labopharm Inc.
Results First Submitted: April 16, 2009  
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

  Participant Flow


  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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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) 
Overall Participants Analyzed 
[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 ]

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 ]

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 ]

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 ]

5.  Secondary:   Number of Participants With Adverse Events   [ Time Frame: 6 hours ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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