A Study of ABT-652 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:
NCT01207115
First received: September 21, 2010
Last updated: January 2, 2013
Last verified: January 2013
  Purpose

To compare the analgesic efficacy and safety of ABT-652 administered twice daily (BID) to placebo in subjects with osteoarthritis (OA) of the knee.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Global Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study Comparing the Analgesic Efficacy and Safety of ABT-652 to Placebo in Subjects With Osteoarthritis Pain of the Knee

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • 24-hour average pain score measured by Visual Analog Scale [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Subject reported pain intensity measured by Visual Analog Scale (0-100)


Secondary Outcome Measures:
  • Western Ontario and McMaster (WOMAC™ ) Osteoarthritis subscales, Pain, Physical Function and Stiffness scores [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Self administered, patient-centered, health status questionnaire

  • Subject's Global Assessment of Arthritis Status [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Subject reported assessment of arthritis status measured by Visual Analogue Scale (0-100)

  • Brief Pain Inventory [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    Subject reported pain intensity and intereference (scale 0-10)

  • SF-36v2™ Health Status Survey [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
    There is no formal title for this quality of life survey, this is the only name for this measure. Subject reported quality of life survey


Enrollment: 322
Study Start Date: September 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-652 high dose
ABT-652 capsules- twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm.
Drug: ABT-652
ABT-652 capsules - twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm
Experimental: ABT-652 low dose
ABT-652 capsules - twice daily for 8 weeks. The dose ABT-652 will depend on the Arm
Drug: ABT-652
ABT-652 capsules - twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm
Active Comparator: Naproxen
Naproxen capsules- twice daily for 8 weeks
Drug: Naproxen
Naproxen capsules - twice daily for 8 weeks
Placebo Comparator: Placebo
Placebo capsules- twice daily for 8 weeks
Drug: Placebo
Placebo capsules - twice daily for 8 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 OA of the knee joint and meeting American College of Rheumatology (ACR) Clinical and Radiographic criteria,
  • Pain score as required by the protocol at Screening and Baseline
  • Willing to washout of analgesics and to follow treatment plan, visit schedules and study procedures.

Exclusion Criteria

  • History of sensitivity to histamine medications, acetaminophen (paracetamol), or non-steroidal anti-inflammatory drugs (NSAIDs)
  • Active gastrointestinal (GI) disease, GI bleeding or GI ulceration, or history of GI bleeding or GI ulceration in the last 6 months
  • History of major psychiatric disorders
  • 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 or other medical condition or illness that is not well controlled with treatment
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01207115

  Show 38 Study Locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Rachel Duan, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01207115     History of Changes
Other Study ID Numbers: M10-889
Study First Received: September 21, 2010
Last Updated: January 2, 2013
Health Authority: Canada: Health Canada
Chile: Instituto de Salud Publica de Chile
Australia: Department of Health and Ageing Therapeutic Goods Administration
United States: Food and Drug Administration

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 15, 2014