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

NCT ID: NCT00952068

Last Updated: 2012-04-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 47 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2007-04-30

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.

Conditions

Acute Low Back Pain

Keywords

Back Pain

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tramadol Contramid® OAD 200mg

1 Tramadol Contramid® OAD 200mg tablet daily.

Group Type: EXPERIMENTAL

Tramadol Contramid® OAD 200mg

Intervention Type: DRUG

1 Tramadol Contramid® OAD 200mg tablet daily.

Interventions

Tramadol Contramid® OAD 200mg

1 Tramadol Contramid® OAD 200mg tablet daily.

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Labopharm Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: RESULT

PMID: 19070266 (View on PubMed)

Related Links

http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseaction=Search.Label_ApprovalHistory

Approved labelling

Other Identifiers

NCT00952068

Identifier Type: REGISTRY

Identifier Source: secondary_id

MDT2-002

Identifier Type: -

Identifier Source: org_study_id