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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01444365
Recruitment Status : Completed
First Posted : September 30, 2011
Last Update Posted : May 15, 2013
Information provided by (Responsible Party):
AbbVie ( 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.

Condition or disease Intervention/treatment Phase
Osteoarthritis of the Knee Drug: ABT-652 NSAID Drug: Placebo NSAID Phase 2

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  (Clinical Trial)
Actual Enrollment : 202 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

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

Primary Outcome Measures :
  1. Subject's Assessment of Arthritis Pain Intensity [ Time Frame: 6 weeks ]
    Subject reported 24-hour average pain score measured by Visual Analogue Scale

Secondary Outcome Measures :
  1. Western Ontario and McMaster (WOMAC™ ) Osteoarthritis Index [ Time Frame: 6 weeks ]
    Self administered, patient-centered, health status questionnaire

  2. Subject's Global Assessment of Arthritis Status [ Time Frame: 6 weeks ]
    Subject reported pain intensity measured by Visual Analog Scale

  3. Cognitive Functioning in Patients with Chronic Pain [ Time Frame: 6 weeks ]
    Subject reported assessment of cognitive functioning

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01444365

  Show 31 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Wolfram Nothaft, MD AbbVie

Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT01444365     History of Changes
Other Study ID Numbers: M13-237
First Posted: September 30, 2011    Key Record Dates
Last Update Posted: May 15, 2013
Last Verified: May 2013

Keywords provided by AbbVie ( AbbVie (prior sponsor, Abbott) ):
Osteoarthritis of the knee

Additional relevant MeSH terms:
Osteoarthritis, Knee
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents