A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the Knee

Phase 2

Completed

• Conditions: Osteoarthritis of the Knee
• Interventions: Drug: ABT-652 NSAID; Drug: Placebo NSAID

• Registration Number: NCT01444365
• Lead Sponsor: AbbVie (prior sponsor, Abbott)

Brief Summary

To evaluate the safety and efficacy of ABT-652 in combination with a Non-steroidal Anti-inflammatory Drug (NSAID) compared to NSAID alone in adults with osteoarthritis (OA) of the knee.

Detailed Description

This is a randomized withdrawal design study, containing a 4 week open-label period followed by a 6 week double-blind period. The total treatment period will be 10 weeks.

Study Timeline

• Study First Submitted: 2011-09-28
• Study First Submitted QC: 2011-09-28
• Study First Posted: 2011-09-30
• Study Start: 2011-10
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Disposition First Submitted: 2013-04-18
• Disposition First Submitted QC: 2013-04-18
• Disposition First Posted: 2013-04-26
• Status Verified: 2013-05
• Last Update Submitted: 2013-05-07
• Last Update Posted: 2013-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

• History of osteoarthritis (OA) of the knee joint and meeting American College of Rheumatology (ACR) Clinical and Radiographic criteria,
• Currently taking nonsteroidal anti-inflammatory drugs (NSAIDs) and still experiencing pain as per the protocol requirements.
• Willing to washout of analgesics and to follow treatment plan, visit schedules and study procedures.

Exclusion Criteria

• Diagnosis of rheumatoid arthritis, autoimmune disorder, arthritis other than osteoarthritis involving the study joint, or other painful syndrome that could interfere with the assessment of pain at the study joint
• Any cardiac, respiratory, neurological, psychiatric disorder or any other medical condition or illness that is not well controlled with treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABT-652 NSAID	ABT-652 NSAID	ABT-652 capsules -2 ABT-652 capsules twice daily (add-on) NSAID - as prescribed
Placebo NSAID	Placebo NSAID	Placebo - 2 placebo capsules twice daily NSAID - as prescribed

Primary Outcome Measures

Name	Time	Method
Subject's Assessment of Arthritis Pain Intensity	6 weeks	Subject reported 24-hour average pain score measured by Visual Analogue Scale

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster (WOMAC™ ) Osteoarthritis Index	6 weeks	Self administered, patient-centered, health status questionnaire
Subject's Global Assessment of Arthritis Status	6 weeks	Subject reported pain intensity measured by Visual Analog Scale
Cognitive Functioning in Patients with Chronic Pain	6 weeks	Subject reported assessment of cognitive functioning

Trial Locations

Locations (31)

Site Reference ID/Investigator# 61257; 🇺🇸 Anaheim, California, United States

Site Reference ID/Investigator# 61226; 🇺🇸 Phoenix, Arizona, United States

Site Reference ID/Investigator# 61235; 🇺🇸 San Antonio, Texas, United States

Site Reference ID/Investigator# 61218; 🇺🇸 Bryan, Texas, United States

Site Reference ID/Investigator# 61260; 🇺🇸 Watertown, Massachusetts, United States

Site Reference ID/Investigator# 61211; 🇺🇸 Oldsmar, Florida, United States

Site Reference ID/Investigator# 61204; 🇺🇸 Long Beach, California, United States

Site Reference ID/Investigator# 61246; 🇺🇸 Fresno, California, United States

Site Reference ID/Investigator# 61231; 🇺🇸 Plantation, Florida, United States

Site Reference ID/Investigator# 61241; 🇺🇸 Tucson, Arizona, United States

Site Reference ID/Investigator# 61234; 🇺🇸 DeLand, Florida, United States

Site Reference ID/Investigator# 61217; 🇺🇸 Orlando, Florida, United States

Site Reference ID/Investigator# 61228; 🇺🇸 Oklahoma City, Oklahoma, United States

Site Reference ID/Investigator# 61232; 🇺🇸 Draper, Utah, United States

Site Reference ID/Investigator# 61244; 🇺🇸 Florissant, Missouri, United States

Site Reference ID/Investigator# 61242; 🇺🇸 La Mesa, California, United States

Site Reference ID/Investigator# 61238; 🇺🇸 Duncansville, Pennsylvania, United States

Site Reference ID/Investigator# 61221; 🇺🇸 Phoenix, Arizona, United States

Site Reference ID/Investigator# 61265; 🇺🇸 Milford, Connecticut, United States

Site Reference ID/Investigator# 61213; 🇺🇸 Ocala, Florida, United States

Site Reference ID/Investigator# 61266; 🇺🇸 St. Louis, Missouri, United States

Site Reference ID/Investigator# 61206; 🇺🇸 Omaha, Nebraska, United States

Site Reference ID/Investigator# 61205; 🇺🇸 Beaumont, Texas, United States

Site Reference ID/Investigator# 61245; 🇺🇸 Tampa, Florida, United States

Site Reference ID/Investigator# 61269; 🇺🇸 Franklin, Wisconsin, United States

Site Reference ID/Investigator# 61273; 🇺🇸 Cincinnati, Ohio, United States

Site Reference ID/Investigator# 61223; 🇺🇸 Salisbury, North Carolina, United States

Site Reference ID/Investigator# 61264; 🇺🇸 Portland, Oregon, United States

Site Reference ID/Investigator# 61258; 🇺🇸 North Hollywood, California, United States

Site Reference ID/Investigator# 61263; 🇺🇸 Marietta, Georgia, United States

Site Reference ID/Investigator# 61210; 🇺🇸 Brockton, Massachusetts, United States