Clinical trial NCT00952068: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Low Back Pain
Keywords: Back Pain
Lead sponsor: Labopharm Inc.
Sponsor class: INDUSTRY
First posted: 2009-08-04
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Time to Onset of Perceptible Pain Relief
timeFrame: 6 hours
Secondary outcomes:
measure: Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose
timeFrame: Baseline, 3 hours post-dose, 6 hours post-dose, time of onset of perceptible pain relief
measure: Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose
timeFrame: 3 hours post-dose, 6 hours post-dose, at time of onset of perceptible pain relief
measure: Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose
timeFrame: Baseline, time of onset of perceptible pain relief, 3 hours post-dose, 6 hours post-dose
measure: Number of Participants With Adverse Events
timeFrame: 6 hours
Other outcomes:
Locations:
Study officials:
References:
citation: 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. doi: 10.5055/jom.2008.0032.