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A Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With Osteoarthritis

NCT00404183 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2011-01-19

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 with placebo over a 5-week dosing period in patients with osteoarthritis.

Conditions

Interventions

DRUG

Extended-Release Hydrocodone/Acetaminophen

2 tablets BID

DRUG

Placebo

2 tablets BID

Sponsors & Collaborators

Principal Investigators

  • Rita Jain, MD · Abbott

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-08-31
Primary Completion
2005-03-31

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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 NCT00404183 on ClinicalTrials.gov