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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01444365
First received: September 28, 2011
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Osteoarthritis of the Knee
Drug: ABT-652 NSAID
Drug: Placebo NSAID
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Subject's Assessment of Arthritis Pain Intensity [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Subject reported 24-hour average pain score measured by Visual Analogue Scale


Secondary Outcome Measures:
  • Western Ontario and McMaster (WOMAC™ ) Osteoarthritis Index [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Self administered, patient-centered, health status questionnaire

  • Subject's Global Assessment of Arthritis Status [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Subject reported pain intensity measured by Visual Analog Scale

  • Cognitive Functioning in Patients with Chronic Pain [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Subject reported assessment of cognitive functioning


Enrollment: 202
Study Start Date: October 2011
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444365

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

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01444365     History of Changes
Other Study ID Numbers: M13-237
Study First Received: September 28, 2011
Last Updated: May 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by AbbVie:
Osteoarthritis of the knee

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

ClinicalTrials.gov processed this record on November 20, 2014