A Study of ABT-652 in Adults With Osteoarthritis Pain of the Knee

January 2, 2013 updated by: AbbVie (prior sponsor, Abbott)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

322

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Brisbane, Australia, 4102
        • Site Reference ID/Investigator# 41782
      • Campsie, Sydney, Australia, 2194
        • Site Reference ID/Investigator# 41779
      • Clayton, Australia, 3168
        • Site Reference ID/Investigator# 41778
      • Fitzroy, Australia, VIC 3065
        • Site Reference ID/Investigator# 41785
      • Kogarah, Australia, 2217
        • Site Reference ID/Investigator# 41582
      • Malvern East, Australia, 3145
        • Site Reference ID/Investigator# 41776
  • Canada
      • Montreal, Canada, H2L 1S6
        • Site Reference ID/Investigator# 41563
      • Newmarket, Canada, L3Y 3R7
        • Site Reference ID/Investigator# 41566
      • Pointe-Claire, Canada, H9J 3W3
        • Site Reference ID/Investigator# 41565
      • Sainte-Foy, Quebec, Canada, G1W 4R4
        • Site Reference ID/Investigator# 41562
  • Chile
      • Santiago, Chile
        • Site Reference ID/Investigator# 41951
  • Puerto Rico
      • Caguas, Puerto Rico, 00725
        • Site Reference ID/Investigator# 37183
      • Ponce, Puerto Rico, 00716
        • Site Reference ID/Investigator# 37622
      • San Juan, Puerto Rico, 00936-8344
        • Site Reference ID/Investigator# 35966
      • Trujillo Alto, Puerto Rico, 00976
        • Site Reference ID/Investigator# 37184
  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Site Reference ID/Investigator# 37220
      • Tempe, Arizona, United States, 85282
        • Site Reference ID/Investigator# 37223
      • Tucson, Arizona, United States, 85704
        • Site Reference ID/Investigator# 37215
    • California
      • Anaheim, California, United States, 92801
        • Site Reference ID/Investigator# 37221
      • Burbank, California, United States, 91505
        • Site Reference ID/Investigator# 37222
      • Chino, California, United States, 91710
        • Site Reference ID/Investigator# 35956
      • La Mesa, California, United States, 91942
        • Site Reference ID/Investigator# 37053
      • Lomita, California, United States, 90717
        • Site Reference ID/Investigator# 37218
    • Connecticut
      • Milford, Connecticut, United States, 06460
        • Site Reference ID/Investigator# 37227
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Site Reference ID/Investigator# 37229
      • Ocala, Florida, United States, 34471
        • Site Reference ID/Investigator# 37209
      • Plantation, Florida, United States, 33317
        • Site Reference ID/Investigator# 37212
      • South Miami, Florida, United States, 33143
        • Site Reference ID/Investigator# 35961
    • Indiana
      • Valparaiso, Indiana, United States, 46383
        • Site Reference ID/Investigator# 37207
    • Minnesota
      • Brooklyn Center, Minnesota, United States, 55430
        • Site Reference ID/Investigator# 37217
    • Missouri
      • St. Louis, Missouri, United States, 63141
        • Site Reference ID/Investigator# 37228
    • New York
      • New York, New York, United States, 10004
        • Site Reference ID/Investigator# 35959
    • North Carolina
      • Salisbury, North Carolina, United States, 28144
        • Site Reference ID/Investigator# 37211
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Site Reference ID/Investigator# 37214
      • Wyomissing, Pennsylvania, United States, 19610
        • Site Reference ID/Investigator# 37205
    • Texas
      • Austin, Texas, United States, 78705
        • Site Reference ID/Investigator# 37208
      • San Antonio, Texas, United States, 78209-1744
        • Site Reference ID/Investigator# 37213
    • Virginia
      • Richmond, Virginia, United States, 23294
        • Site Reference ID/Investigator# 35953

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster (WOMAC™ ) Osteoarthritis subscales, Pain, Physical Function and Stiffness scores
Time Frame: 8 weeks
Self administered, patient-centered, health status questionnaire
8 weeks
Subject's Global Assessment of Arthritis Status
Time Frame: 8 weeks
Subject reported assessment of arthritis status measured by Visual Analogue Scale (0-100)
8 weeks
Brief Pain Inventory
Time Frame: 8 weeks
Subject reported pain intensity and intereference (scale 0-10)
8 weeks
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
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie (prior sponsor, Abbott)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

September 21, 2010

First Submitted That Met QC Criteria

September 21, 2010

First Posted (Estimate)

September 22, 2010

Study Record Updates

Last Update Posted (Estimate)

January 7, 2013

Last Update Submitted That Met QC Criteria

January 2, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M10-889

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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