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: “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”

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.

Intervention(s) in this Clinical Trial

• Drug: Tramadol Contramid® OAD 200mg
  • 1 Tramadol Contramid® OAD 200mg tablet daily.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Tramadol Contramid® OAD 200mg
  • 1 Tramadol Contramid® OAD 200mg tablet daily.

Primary Measures

• Time to Onset of Perceptible Pain Relief
  • Time Frame: 6 hours
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• 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
    Safety Issue?: No
• Number of Participants With Adverse Events
  • Time Frame: 6 hours
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Labopharm Inc. Industry

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00952068

Study ID Number: MDT2-002

ClinicalTrials.gov Identifier: NCT00952068

Health Authority: Romania: National Medicines Agency

Approved labelling