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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
322

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 7, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 2, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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