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

Tracking Information

First Received Date ^ICMJE

November 26, 2006

Last Updated Date

April 21, 2009

Start Date ^ICMJE

August 2004

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Pain intensity difference from baseline to final assessment using the VAS scale (100 mm, 0 being "no pain" and 100 being "worst pain imaginable").

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00404183 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

WOMAC Osteoarthritis Index
MOS Sleep Scale
Pain Intensity difference as assessed by the Subject's Assessment of Arthritis Pain Intensity by VAS (at each scheduled assessment other than final)
Subject's Global Assessment of Study Drug
Subject's and Physician's Global Assessment of Arthritis Status
Time-interval weighted measure of pain intensity difference from baseline (area under the curve) divided by the maximum benefit possible for an individual subject
Treatment responders
SF-36v2TM Health Status Survey (Acute)

Original Secondary Outcome Measures ^ICMJE

WOMAC Osteoarthritis Index
MOS Sleep Scale
Pain Intensity difference as assessed by the Subject’s Assessment of Arthritis Pain Intensity by VAS (at each scheduled assessment other than final)
Subject’s Global Assessment of Study Drug
Subject’s and Physician’s Global Assessment of Arthritis Status
Time-interval weighted measure of pain intensity difference from baseline (area under the curve) divided by the maximum benefit possible for an individual subject
Treatment responders
SF-36v2TM Health Status Survey (Acute)

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Randomized, Multi-Center, Double-Blind Study Comparing the Analgesic Efficacy and Safety of Extended Release Hydrocodone/Acetaminophen (Vicodin® CR)and Placebo in Subjects With Osteoarthritis

Brief 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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Pain

Intervention ^ICMJE

Drug: Extended-Release Hydrocodone/Acetaminophen (Vicodin® CR)

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

120

Completion Date

March 2005

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

21 Years to 75 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Administrative Information

NCT ID ^ICMJE

NCT00404183

Responsible Party

Study ID Numbers ^ICMJE

M03-643

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Rita Jain, MD

Abbott

Information Provided By

Abbott

Verification Date

July 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP