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A Study Comparing Vicodin® CR and NORCO® to Placebo in Subjects With Acute Pain Following Bunionectomy

NCT00404222 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2011-07-25

No results posted yet for this study

Summary

The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of Extended Release Hydrocodone/Acetaminophen and Immediate Release Hydrocodone/Acetaminophen with placebo over a 12 hour dosing period in patients who have had a bunionectomy, and to assess the safety of the drug for 7 days after patients are discharged from the hospital.

Conditions

Interventions

DRUG

Hydrocodone/Acetaminophen Extended-Release

2 tablets x 1

DRUG

Hydrocodone/Acetaminophen Immediate Release (NORCO®)

1 tablet q 4 hours x 3

DRUG

Placebo

q 4 hours x 3

Sponsors & Collaborators

Principal Investigators

  • Rita Jain, MD · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2006-02-28
Completion
2006-02-28

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Entities

Drugs
Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00404222 on ClinicalTrials.gov