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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
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


  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)  
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 ]

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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