CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 250 enrolled
Drug / intervention
Hydrocodone/Acetaminophen Extended Release +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01038609
NCT01038609Phase 2Completed
CompareCT.gov

A Randomized, Multicenter, Single-Blind Study Comparing Hydrocodone/Acetaminophen Extended Release 10/650, Morphine Extended Release, and Acetaminophen to Placebo in Subjects With Acute Pain Following Bunionectomy

AbbVie (prior sponsor, Abbott)·interventional·Posted Dec 24, 2009·Updated Apr 8, 2014

In Brief

A Phase 2 clinical trial evaluating Hydrocodone/Acetaminophen Extended Release, Acetaminophen, and 2 other interventions for Pain. Completed, enrolled 250 participants across 4 sites.

Detailed Summary

The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain following primary unilateral first metatarsal bunionectomy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 24, 2009
Enrollment StartDec 1, 2009
Primary CompletionMay 1, 2010
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.5 years ago

Interventions

Hydrocodone/Acetaminophen Extended Releasedrug

Acetaminophendrug

Morphine Extended Releasedrug

Placebodrug