drugset / Trial / NCT00404391

A Study Comparing the Analgesic Activity of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR) and Placebo in Subjects With Pain Following Bunionectomy Surgery

NCT00404391 ↗

Phase 2 Completed 210 enrolled Abbott
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of Extended Release Hydrocodone/Acetaminophen with placebo over a 48 hour dosing period in patients who have had bunionectomy surgery, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.

Timeline

Start
2003-10
Primary completion
2004-03
Completion
2004-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Hydrocodone/Acetaminophen Unknown — —

Indications

No indication recorded.