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

Labopharm

Status and phase

Completed

Phase 2

Conditions

Acute Low Back Pain

Treatments

Drug: Tramadol Contramid® OAD 200mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT00952068

MDT2-002

NCT00952068 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment

47 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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