A Randomized, Double-Blind, Placebo-Controlled Study Comparing the Analgesic Activity of Hydrocodone/Acetaminophen Extended Release and Placebo in Subjects With Pain Following Bunionectomy Surgery

Abbott4 sites in 1 country210 target enrollmentOctober 2003

ConditionsPain

InterventionsHydrocodone/Acetaminophen Extended Release Placebo

DrugsHydrocodone/Acetaminophen Extended Release Placebo

Overview

Phase: Phase 2
Intervention: Hydrocodone/Acetaminophen Extended Release
Conditions: Pain
Sponsor: Abbott
Enrollment: 210
Locations: 4
Primary Endpoint: Time-interval-weighted sum of pain relief (TOTPAR)score for 0 to 12 hours following the first dose of study drug administration
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 2003

End Date

March 2004

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott

Eligibility Criteria

Inclusion Criteria

•Male or female ages 18 to 65
•Females must be of non-childbearing potential or practicing birth control
•Subject is scheduled to undergo primary, unilateral first metatarsal bunionectomy surgery

Exclusion Criteria

•Is allergic to or has a serious reaction to hydrocodone, or other opioids, acetaminophen, lidocaine or propofol, and/or similar drugs
•Has initiated corticosteroid therapy within the past month or is scheduled to receive any corticosteroid during the study
•Is associated with any currently ongoing research study