Status:
COMPLETED
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
Lead Sponsor:
Labopharm Inc.
Conditions:
Acute Low Back Pain
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
47 Patients enrolled
Trial Details
Trial ID
NCT00952068
Start Date
January 1 2007
End Date
April 1 2007
Last Update
April 30 2012
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