A Study of Pain Relief in Osteoarthritis - Tabular View

Tracking Information

First Received Date ^ICMJE

March 2, 2006

Last Updated Date

October 24, 2007

Start Date ^ICMJE

February 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

The mean absolute pain intensity difference from baseline to each subject's Week 12 evaluation

Original Primary Outcome Measures ^ICMJE

The mean absolute pain intensity difference from baseline to each subject’s Week 12 evaluation

Change History

Complete list of historical versions of study NCT00298974 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Pain intensity difference from baseline to each scheduled evaluation
Proportion of treatment responders
Global assessments of study drug and arthritis status
Western Ontario and McMaster (WOMAC) Osteoarthritis Index total score and 3 subscales
SF-36v2 Health Status Survey

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Study of Pain Relief in Osteoarthritis

Official Title ^ICMJE

A Phase 3, Randomized, Multicenter, Double-Blind Study Comparing the Analgesic Efficacy of Extended Release Hydrocodone/Acetaminophen Tablets (Vicodin CR) to Placebo in Subjects With Osteoarthritis

Brief Summary

The purpose of this study is to compare the safety and pain-relieving ability of Vicodin CR to placebo in subjects with osteoarthritis (OA) of the hip or knee.

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Osteoarthritis

Intervention ^ICMJE

Drug: 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

800

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Males and females ages 21 to 80
If female, must be of non-child bearing potential or practicing birth control
Has osteoarthritis of the hip or knee
Requires therapeutic doses of medication for osteoarthritis pain
Has sufficient pain to justify the use of around-the-clock opioids

Exclusion Criteria:

Is associated with any currently ongoing research study, or has previously participated in a Vicodin CR study
Is allergic to or has had a serious reaction to hydrocodone, other opioids, or acetaminophen
Cannot discontinue pain medications, even for the short time prior to the study start
Has any clinically significant illness or recent injury, or has any significant laboratory abnormality, or has recently had major surgery
Has a history of gastric bypass surgery or preexisting severe gastrointestinal narrowing, or history of diseases that may narrow the gastrointestinal tract
Has a history of malnutrition or starvation
Has a history of drug (licit or illicit) or alcohol abuse or addiction, or consumes more than 4 alcoholic drinks per day
Has a history of a major depressive episode within the past 2 years, or requires treatment with certain drugs for depression, or has a history of major psychiatric disorder
Pregnant or breastfeeding females
Is incapacitated, bedridden or confined to a wheelchair
Has initiated any new therapy or medication for OA within 1 month of screening
Has had surgery, certain types of procedures, or received certain medications for osteoarthritis within a specified time frame
Has other conditions that may cause pain, such as rheumatoid arthritis or gout

Gender

Both

Ages

21 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00298974

Responsible Party

Study ID Numbers ^ICMJE

M04-697

Study Sponsor ^ICMJE

Abbott

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Rita Jain, M.D.

Abbott

Information Provided By

Abbott

Verification Date

October 2007

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