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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

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ClinicalTrials.gov Identifier: NCT00952068
Recruitment Status : Completed
First Posted : August 4, 2009
Results First Posted : August 4, 2009
Last Update Posted : April 30, 2012
Sponsor:
Information provided by (Responsible Party):
Labopharm Inc.

Tracking Information
First Submitted Date  ICMJE April 16, 2009
First Posted Date  ICMJE August 4, 2009
Results First Submitted Date  ICMJE April 16, 2009
Results First Posted Date  ICMJE August 4, 2009
Last Update Posted Date April 30, 2012
Study Start Date  ICMJE January 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 19, 2011)
Time to Onset of Perceptible Pain Relief [ Time Frame: 6 hours ]
Kaplan-Meier estimates of time to perceptible pain relief. Patients who discontinued or completed the study without perceptible pain relief were censored at the time point of their last pain intensity score. A confidence interval for the median survival time was calculated.
Original Primary Outcome Measures  ICMJE
 (submitted: June 18, 2009)
Time to Onset of Perceptible Pain Relief [ Time Frame: 6 hours ]
Change History Complete list of historical versions of study NCT00952068 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 19, 2011)
  • 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 ]
    Pain intensity rating at baseline, time of onset of perceptible pain relief, 3 hours and 6 hours post-dose or if the patient discontinued earlier. "What is your current level of pain intensity?" 0=none, 1=mild, 2=moderate, 3=severe. Missing data were imputed using Last Observation Carried Forward (LOCF).
  • 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 ]
    Pain relief rating at time of onset of perceptible pain relief, 3 hours and 6 hours post-dose or if the patient discontinued earlier. " How would you rate the pain relief the study medication has given you?" ranging from 0=none to 4=complete relief. Missing data were imputed using Last Observation Carried Forward (LOCF).
  • 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 ]
    PK samples were drawn at the end of the Screening Phase, at the onset of perceptible pain relief, at 3 hours and at 6 hours post-dose or if the patient discontinues early. PK samples were always drawn after the completion of the patient ratings of pain relief and of pain intensity scales. They were processed in a central laboratory and the plasma levels of tramadol were collected.
  • Number of Participants With Adverse Events [ Time Frame: 6 hours ]
    All adverse events reported during treatment with study drug were considered and reported as treatment emergent adverse events (TEAE) whether or not medication for this adverse event was required by the participant and were summarized in the same table.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 18, 2009)
  • 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 ]
  • 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 ]
  • Pharmacokinetic Samples 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 ]
  • Number of Participants With Adverse Events [ Time Frame: 6 hours ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
Brief Summary The primary objective of this study is to determine the time of onset of analgesic effect of Tramadol Contramid® Once-A-Day (OAD) in acute low back pain. Secondary objectives include determining the relationship between analgesic effect and plasma levels for Tramadol Contramid® OAD and to examine safety after single dose administration of 200 mg of Tramadol Contramid® OAD.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Low Back Pain
Intervention  ICMJE Drug: Tramadol Contramid® OAD 200mg
1 Tramadol Contramid® OAD 200mg tablet daily.
Study Arms  ICMJE Experimental: Tramadol Contramid® OAD 200mg
1 Tramadol Contramid® OAD 200mg tablet daily.
Intervention: Drug: Tramadol Contramid® OAD 200mg
Publications * Sarbu A, Radulescu F, Robertson S, Bouchard S. Onset of analgesic effect and plasma levels of controlled-release tramadol (Tramadol Contramid once-a-day) 200-mg tablets in patients with acute low back pain. J Opioid Manag. 2008 Sep-Oct;4(5):285-92.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2009)
47
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2007
Actual Primary Completion Date April 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males or females in generally good health aged 18-80 years with acute low back pain are eligible for this study.
  • Patients must have pain of moderate to severe intensity on the patient rating of pain intensity scale without analgesia.
  • Oral and written language comprehension at a level sufficient to comply with the protocol and complete study-related materials.
  • Must have signed and dated an REB-approved written Informed Consent form which was also signed and dated by the Investigator prior to study participation.

Exclusion Criteria:

  • Known history or symptoms suspicious of:

    • Spinal fracture
    • Cancer (i.e. constitutional symptoms such as recent unexplained chills or weight loss)
    • Spinal infection (e.g. IV drug abuse, immunosuppression)
  • Cauda equina syndrome
  • Spina bifida
  • Foot drop
  • Spinal surgery within 1 year of study entry
  • Body Mass Index (BMI) > 37
  • Continuous chronic back pain
  • More severe pain in a region other than the lower back
  • Treatment of the back pain with non-pharmacological therapy (e.g. acupuncture chiropractic adjustment, Transcutaneous Electrical Nerve Stimulation, physiotherapy etc.) in the 3 weeks prior to study entry
  • Use of any sedative hypnotics, topical preparations/medications and anaesthetics or muscle relaxants within 5 half-lives of the dose of study medication
  • Use of any analgesic within 6 hours of the dose of study medication. In rare cases, if a patient is in moderate to severe pain despite having taken a short-acting analgesic and if at least 2 hours have passed since the dose of short-acting analgesic, the patient may be entered.
  • A major illness, requiring hospitalisation during the 3 months before commencement of the screening period
  • Unwillingness to stop taking pain medication other than the study medication
  • Previous failure of treatment with tramadol or discontinuation of treatment with tramadol due to adverse events
  • Treatment within the last 3 weeks with any of the following medications: monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds (e.g. cyclobenzaprine, promethazine); neuroleptics; selective serotonin reuptake inhibitors (SSRIs); serotonin-norepinephrine reuptake inhibitors (SNRIs) or any other drug that reduces seizure threshold
  • Treatment with another investigational agent within the last 30 days
  • History of seizure disorder other than Infantile Febrile Seizures
  • Previous or current opioid dependency
  • Bowel disease causing malabsorption
  • Pregnant or lactating women
  • Known significant liver disease or symptoms of significant liver disease
  • Known significant renal disease or symptoms of significant renal disease
  • Current or past substance abuse or dependence, other than nicotine
  • Allergy to tramadol or any structurally similar drugs (e.g. opiates)
  • Any other condition that, in the opinion of the Investigators, would adversely affect the patient's ability to complete the study or its measures
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00952068
Other Study ID Numbers  ICMJE MDT2-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Labopharm Inc.
Study Sponsor  ICMJE Labopharm Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Labopharm Inc.
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP