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

May 7, 2013 updated by: AbbVie (prior sponsor, Abbott)

A Phase 2, Randomized Withdrawal Study of the Analgesic Efficacy and Safety of ABT-652 as an Add On Therapy in Subjects With Osteoarthritis of the Knee Experiencing Partial Benefit of a Nonsteroidal Anti-Inflammatory Drug

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

202

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85023
        • Site Reference ID/Investigator# 61226
      • Phoenix, Arizona, United States, 85032
        • Site Reference ID/Investigator# 61221
      • Tucson, Arizona, United States, 85704
        • Site Reference ID/Investigator# 61241
    • California
      • Anaheim, California, United States, 92801
        • Site Reference ID/Investigator# 61257
      • Fresno, California, United States, 93726
        • Site Reference ID/Investigator# 61246
      • La Mesa, California, United States, 91942
        • Site Reference ID/Investigator# 61242
      • Long Beach, California, United States, 90806
        • Site Reference ID/Investigator# 61204
      • North Hollywood, California, United States, 91606
        • Site Reference ID/Investigator# 61258
    • Connecticut
      • Milford, Connecticut, United States, 06460
        • Site Reference ID/Investigator# 61265
    • Florida
      • DeLand, Florida, United States, 32720
        • Site Reference ID/Investigator# 61234
      • Ocala, Florida, United States, 34471
        • Site Reference ID/Investigator# 61213
      • Oldsmar, Florida, United States, 34677
        • Site Reference ID/Investigator# 61211
      • Orlando, Florida, United States, 32806
        • Site Reference ID/Investigator# 61217
      • Plantation, Florida, United States, 33317
        • Site Reference ID/Investigator# 61231
      • Tampa, Florida, United States, 33603
        • Site Reference ID/Investigator# 61245
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Site Reference ID/Investigator# 61263
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
        • Site Reference ID/Investigator# 61210
      • Watertown, Massachusetts, United States, 02472-3930
        • Site Reference ID/Investigator# 61260
    • Missouri
      • Florissant, Missouri, United States, 63031
        • Site Reference ID/Investigator# 61244
      • St. Louis, Missouri, United States, 63141
        • Site Reference ID/Investigator# 61266
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Site Reference ID/Investigator# 61206
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • Site Reference ID/Investigator# 61223
    • Ohio
      • Cincinnati, Ohio, United States, 45245
        • Site Reference ID/Investigator# 61273
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73109
        • Site Reference ID/Investigator# 61228
    • Oregon
      • Portland, Oregon, United States, 97239
        • Site Reference ID/Investigator# 61264
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Site Reference ID/Investigator# 61238
    • Texas
      • Beaumont, Texas, United States, 77701
        • Site Reference ID/Investigator# 61205
      • Bryan, Texas, United States, 77802
        • Site Reference ID/Investigator# 61218
      • San Antonio, Texas, United States, 78209
        • Site Reference ID/Investigator# 61235
    • Utah
      • Draper, Utah, United States, 84020
        • Site Reference ID/Investigator# 61232
    • Wisconsin
      • Franklin, Wisconsin, United States, 53132
        • Site Reference ID/Investigator# 61269

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ABT-652 NSAID
ABT-652 capsules -2 ABT-652 capsules twice daily (add-on) NSAID - as prescribed
Drug: ABT-652 NSAID
ABT-652 capsules - 2 ABT-652 capsules twice daily (add-on) NSAID- as prescribed
PLACEBO_COMPARATOR: Placebo NSAID
Placebo - 2 placebo capsules twice daily NSAID - as prescribed
Drug: Placebo NSAID
Placebo - 2 placebo capsules twice daily NSAID- as prescribed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subject's Assessment of Arthritis Pain Intensity
Time Frame: 6 weeks
Subject reported 24-hour average pain score measured by Visual Analogue Scale
6 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

September 28, 2011

First Submitted That Met QC Criteria

September 28, 2011

First Posted (ESTIMATE)

September 30, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

May 15, 2013

Last Update Submitted That Met QC Criteria

May 7, 2013

Last Verified

May 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M13-237

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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