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

NCT01444365 | Completed Phase 2

• 1 other identifier: M13-237
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 31

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.

Conditions

Osteoarthritis of the Knee

Keywords

Osteoarthritis of the knee

Outcome Measures

Primary Outcomes (1)

• Subject's Assessment of Arthritis Pain Intensity

  Subject reported 24-hour average pain score measured by Visual Analogue Scale

  6 weeks

Secondary Outcomes (3)

• Western Ontario and McMaster (WOMAC™ ) Osteoarthritis Index

  6 weeks

• Subject's Global Assessment of Arthritis Status

  6 weeks

• Cognitive Functioning in Patients with Chronic Pain

  6 weeks

Study Arms (2)

ABT-652 NSAID

EXPERIMENTAL

ABT-652 capsules -2 ABT-652 capsules twice daily (add-on) NSAID - as prescribed

Drug: ABT-652 NSAID

Placebo NSAID

PLACEBO COMPARATOR

Placebo - 2 placebo capsules twice daily NSAID - as prescribed

Drug: Placebo NSAID

Interventions

ABT-652 NSAID DRUG

ABT-652 capsules - 2 ABT-652 capsules twice daily (add-on) NSAID- as prescribed

ABT-652 NSAID

Placebo NSAID DRUG

Placebo - 2 placebo capsules twice daily NSAID- as prescribed

Placebo NSAID

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Study Sites (31)

Site Reference ID/Investigator# 61226

Phoenix, Arizona, 85023, United States

Location

Site Reference ID/Investigator# 61221

Phoenix, Arizona, 85032, United States

Location

Site Reference ID/Investigator# 61241

Tucson, Arizona, 85704, United States

Location

Site Reference ID/Investigator# 61257

Anaheim, California, 92801, United States

Location

Site Reference ID/Investigator# 61246

Fresno, California, 93726, United States

Location

Site Reference ID/Investigator# 61242

La Mesa, California, 91942, United States

Location

Site Reference ID/Investigator# 61204

Long Beach, California, 90806, United States

Location

Site Reference ID/Investigator# 61258

North Hollywood, California, 91606, United States

Location

Site Reference ID/Investigator# 61265

Milford, Connecticut, 06460, United States

Location

Site Reference ID/Investigator# 61234

DeLand, Florida, 32720, United States

Location

Site Reference ID/Investigator# 61213

Ocala, Florida, 34471, United States

Location

Site Reference ID/Investigator# 61211

Oldsmar, Florida, 34677, United States

Location

Site Reference ID/Investigator# 61217

Orlando, Florida, 32806, United States

Location

Site Reference ID/Investigator# 61231

Plantation, Florida, 33317, United States

Location

Site Reference ID/Investigator# 61245

Tampa, Florida, 33603, United States

Location

Site Reference ID/Investigator# 61263

Marietta, Georgia, 30060, United States

Location

Site Reference ID/Investigator# 61210

Brockton, Massachusetts, 02301, United States

Location

Site Reference ID/Investigator# 61260

Watertown, Massachusetts, 02472-3930, United States

Location

Site Reference ID/Investigator# 61244

Florissant, Missouri, 63031, United States

Location

Site Reference ID/Investigator# 61266

St Louis, Missouri, 63141, United States

Location

Site Reference ID/Investigator# 61206

Omaha, Nebraska, 68134, United States

Location

Site Reference ID/Investigator# 61223

Salisbury, North Carolina, 28144, United States

Location

Site Reference ID/Investigator# 61273

Cincinnati, Ohio, 45245, United States

Location

Site Reference ID/Investigator# 61228

Oklahoma City, Oklahoma, 73109, United States

Location

Site Reference ID/Investigator# 61264

Portland, Oregon, 97239, United States

Location

Site Reference ID/Investigator# 61238

Duncansville, Pennsylvania, 16635, United States

Location

Site Reference ID/Investigator# 61205

Beaumont, Texas, 77701, United States

Location

Site Reference ID/Investigator# 61218

Bryan, Texas, 77802, United States

Location

Site Reference ID/Investigator# 61235

San Antonio, Texas, 78209, United States

Location

Site Reference ID/Investigator# 61232

Draper, Utah, 84020, United States

Location

Site Reference ID/Investigator# 61269

Franklin, Wisconsin, 53132, United States

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Wolfram Nothaft, MD

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2011
• First Posted: September 30, 2011
• Study Start: October 1, 2011
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: May 15, 2013

Record last verified: 2013-05

Locations

US (31)