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Completed

NCT Number: NCT01444365

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

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.

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Key information

Conditions

Osteoarthritis of the Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ABT-652 NSAID

Drug

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

Placebo NSAID

Drug

Placebo - 2 placebo capsules twice daily NSAID- as prescribed

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 30, 2011
Registry last updated
May 15, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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