drugset
drugset / Trial / NCT00210561

A Study of the Effectiveness and Safety of Tramadol HCl/Acetaminophen Compared to Placebo in Treating Acute Low Back Pain

NCT00210561 ↗

Phase 4 Terminated 22 enrolled Johnson & Johnson Pharmaceutical Research & Development, L.L.C. PriCara, Unit of Ortho-McNeil, Inc. · collab
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to explore the pain-relieving effects and safety of Tramadol HCl/acetaminophen as compared to placebo in patients experiencing acute low back pain. Tramadol HCl/acetaminophen is approved for short-term management of acute pain. The combination of tramadol HCl/acetaminophen has been shown to be effective for the treatment of acute musculoskeletal pain. Patients who experienced at least moderate acute low back pain for 2 to 10 days before study entry will be randomized to receive either tramadol HCl/acetaminophen or placebo.

Timeline

Start
2005-03
Primary completion
—
Completion
2005-04

Outcome

Outcome not reported

Stopped (Business): “Study was stopped shortly after initiation due to change in strategic direction of the company; no safety concerns were observed that impacted this decision.”

Drugs

EvaluationDrugModalityDoseRoute
Subject Acetaminophen Small molecule 325 mg Oral
Subject Tramadol Other / unclassified 37.5 mg Oral

Indications

No indication recorded.