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 ↗

Phase 2 Completed 47 enrolled Labopharm Inc.

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start: 2007-01
Primary completion: 2007-04
Completion: 2007-04

Publications

Results 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Tramadol	Other / unclassified	200 mg	—

Indications

No indication recorded.