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
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: 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 Pública 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 September 29, 2014