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

Abbott0 sites120 target enrollmentAugust 2004

ConditionsPain

InterventionsExtended-Release Hydrocodone/Acetaminophen Placebo

DrugsExtended-Release Hydrocodone/Acetaminophen Placebo

Overview

Phase: Phase 2
Intervention: Extended-Release Hydrocodone/Acetaminophen
Conditions: Pain
Sponsor: Abbott
Enrollment: 120
Primary Endpoint: Pain intensity difference from baseline to final assessment using the VAS scale (100 mm, 0 being "no pain" and 100 being "worst pain imaginable").
Status: Completed
Last Updated: 15 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

August 2004

End Date

March 2005

Last Updated

15 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Abbott

Eligibility Criteria

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