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Completed

NCT Number: NCT01207115

A Study of ABT-652 in Adults 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.

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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# 41782, Brisbane, Australia

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ABT-652

Drug

ABT-652 capsules - twice daily for 8 weeks. The dose of ABT-652 will depend on the Arm

Placebo

Drug

Placebo capsules - twice daily for 8 weeks

Naproxen

Drug

Naproxen capsules - twice daily for 8 weeks

Primary outcomes

  1. 24-hour average pain score measured by Visual Analog Scale

    Time frame: 8 weeks

    Subject reported pain intensity measured by Visual Analog Scale (0-100)

Secondary outcomes

  1. Western Ontario and McMaster (WOMAC™ ) Osteoarthritis subscales, Pain, Physical Function and Stiffness scores

    Time frame: 8 weeks

    Self administered, patient-centered, health status questionnaire

  2. Subject's Global Assessment of Arthritis Status

    Time frame: 8 weeks

    Subject reported assessment of arthritis status measured by Visual Analogue Scale (0-100)

  3. Brief Pain Inventory

    Time frame: 8 weeks

    Subject reported pain intensity and intereference (scale 0-10)

  4. SF-36v2™ Health Status Survey

    Time frame: 8 weeks

    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

Sponsors and collaborators

Lead sponsor

AbbVie (prior sponsor, Abbott)

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Sep 22, 2010
Registry last updated
Jan 7, 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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