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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Labopharm Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Tramadol Contramid® OAD 200mg	1 Tramadol Contramid® OAD 200mg tablet daily.

Timeline

• Start date: 2007-01-01
• Primary completion: 2007-04-01
• Completion: 2007-04-01
• First posted: 2009-08-04
• Last updated: 2012-04-30
• Results posted: 2009-08-04