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

January 14, 2011 updated by: Abbott

A Randomized, Multi-center, Double-blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen and Placebo in Subjects With Osteoarthritis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females ages 21 to 75
  • Has osteoarthritis of the hip or knee
  • Requires therapeutic doses of medications for osteoarthritis
  • If female, must be of non-childbearing potential or practicing birth control
  • Has sufficient pain to justify the use of round-the-clock opioids

Exclusion Criteria:

  • Has received certain types of procedures or received certain medications for osteoarthritis within a specific timeframe
  • Has certain medical conditions which may interfere with pain assessments
  • Is allergic to or has a serious reaction to hydrocodone, other opioids, or acetaminophen
  • Has had certain infections, injuries or illnesses within the last month
  • Has had major abdominal surgery, certain diseases that may cause intestinal narrowing, or has a history of constipation, diarrhea or nausea and vomiting
  • Is receiving chemotherapy, or has been diagnosed with certain cancers within the past 5 years
  • Has a history of major psychiatric disorders or requires treatment with certain drugs for depression
  • Cannot discontinue pain medications, even for a short time, prior to the study start

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
2 tablets BID
EXPERIMENTAL: hydrocodone/acetaminophen extended release
Drug: Extended-Release Hydrocodone/Acetaminophen
2 tablets BID
Other Names:
  • ABT-712
  • hydrocodone/acetaminophen extended release

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity difference from baseline to final assessment using the VAS scale (100 mm, 0 being "no pain" and 100 being "worst pain imaginable").
Time Frame: 4 weeks
Arthritis Pain Intensity measured by a 100mm Visial Analog Scase (VAS)
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
WOMAC Osteoarthritis Index, SF36
Time Frame: 4 weeks
Osteoarthritis Index
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (ACTUAL)

March 1, 2005

Study Registration Dates

First Submitted

November 26, 2006

First Submitted That Met QC Criteria

November 26, 2006

First Posted (ESTIMATE)

November 28, 2006

Study Record Updates

Last Update Posted (ESTIMATE)

January 19, 2011

Last Update Submitted That Met QC Criteria

January 14, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M03-643

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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