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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

September 21, 2010
January 2, 2013
September 2010
May 2011   (final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT01207115 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee
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

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

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Osteoarthritis of the Knee
  • Drug: ABT-652
    ABT-652 capsules - twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm
  • Drug: Placebo
    Placebo capsules - twice daily for 8 weeks
  • Drug: Naproxen
    Naproxen capsules - twice daily for 8 weeks
  • Experimental: ABT-652 high dose
    ABT-652 capsules- twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm.
    Intervention: Drug: ABT-652
  • Experimental: ABT-652 low dose
    ABT-652 capsules - twice daily for 8 weeks. The dose ABT-652 will depend on the Arm
    Intervention: Drug: ABT-652
  • Active Comparator: Naproxen
    Naproxen capsules- twice daily for 8 weeks
    Intervention: Drug: Naproxen
  • Placebo Comparator: Placebo
    Placebo capsules- twice daily for 8 weeks
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
322
May 2011
May 2011   (final data collection date for primary outcome measure)

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
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Chile,   Puerto Rico
 
NCT01207115
M10-889
Yes
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Rachel Duan, MD AbbVie
AbbVie
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP