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

NCT00952068 | Completed Phase 2 Results

• 2 other identifiers: MDT2-002NCT00952068
• Study Type: interventional
• Target: 47
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Time to Onset of Perceptible Pain Relief

  Kaplan-Meier estimates of time to perceptible pain relief. Patients who discontinued or completed the study without perceptible pain relief were censored at the time point of their last pain intensity score. A confidence interval for the median survival time was calculated.

  6 hours

Secondary Outcomes (4)

• Patient Rating of Pain Intensity at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose

  Baseline, 3 hours post-dose, 6 hours post-dose, time of onset of perceptible pain relief

• Patient Rating of Pain Relief at Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post Dose

  3 hours post-dose, 6 hours post-dose, at time of onset of perceptible pain relief

• Plasma Levels of Tramadol at 0 Hour (Baseline), Onset of Perceptible Pain Relief, 3 Hours and 6 Hours Post-dose

  Baseline, time of onset of perceptible pain relief, 3 hours post-dose, 6 hours post-dose

• Number of Participants With Adverse Events

  6 hours

Study Arms (1)

Tramadol Contramid® OAD 200mg

EXPERIMENTAL

1 Tramadol Contramid® OAD 200mg tablet daily.

Drug: Tramadol Contramid® OAD 200mg

Interventions

Tramadol Contramid® OAD 200mg DRUG

1 Tramadol Contramid® OAD 200mg tablet daily.

Tramadol Contramid® OAD 200mg

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Labopharm Inc.: lead

Related Publications (1)

• 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.

  PMID: 19070266 RESULT

Related Links

• Approved labelling

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Regulatory Affairs
• Organization: Labopharm Inc.

1 450 686 1017

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2009
• First Posted: August 4, 2009
• Study Start: January 1, 2007
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: April 30, 2012
• Results First Posted: August 4, 2009

Record last verified: 2012-04