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A Study of ABT-652 in Combination With a Nonsteroidal Anti-Inflammatory Drug (NSAID) in Adults With Osteoarthritis Pain of the Knee

NCT ID: NCT01444365

Last Updated: 2013-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

202 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2012-04-30

Brief Summary

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To evaluate the safety and efficacy of ABT-652 in combination with a Non-steroidal Anti-inflammatory Drug (NSAID) compared to NSAID alone in adults with osteoarthritis (OA) of the knee.

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Detailed Description

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This is a randomized withdrawal design study, containing a 4 week open-label period followed by a 6 week double-blind period. The total treatment period will be 10 weeks.

Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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ABT-652 NSAID

ABT-652 capsules -2 ABT-652 capsules twice daily (add-on) NSAID - as prescribed

Group Type EXPERIMENTAL

ABT-652 NSAID

Intervention Type DRUG

ABT-652 capsules - 2 ABT-652 capsules twice daily (add-on) NSAID- as prescribed

Placebo NSAID

Placebo - 2 placebo capsules twice daily NSAID - as prescribed

Group Type PLACEBO_COMPARATOR

Placebo NSAID

Intervention Type DRUG

Placebo - 2 placebo capsules twice daily NSAID- as prescribed

Interventions

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ABT-652 NSAID

ABT-652 capsules - 2 ABT-652 capsules twice daily (add-on) NSAID- as prescribed

Intervention Type DRUG

Placebo NSAID

Placebo - 2 placebo capsules twice daily NSAID- as prescribed

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* History of osteoarthritis (OA) of the knee joint and meeting American College of Rheumatology (ACR) Clinical and Radiographic criteria,
* Currently taking nonsteroidal anti-inflammatory drugs (NSAIDs) and still experiencing pain as per the protocol requirements.
* Willing to washout of analgesics and to follow treatment plan, visit schedules and study procedures.

Exclusion Criteria

* 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, psychiatric disorder or any other medical condition or illness that is not well controlled with treatment
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Wolfram Nothaft, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 61226

Phoenix, Arizona, United States

Site Status

Site Reference ID/Investigator# 61221

Phoenix, Arizona, United States

Site Status

Site Reference ID/Investigator# 61241

Tucson, Arizona, United States

Site Status

Site Reference ID/Investigator# 61257

Anaheim, California, United States

Site Status

Site Reference ID/Investigator# 61246

Fresno, California, United States

Site Status

Site Reference ID/Investigator# 61242

La Mesa, California, United States

Site Status

Site Reference ID/Investigator# 61204

Long Beach, California, United States

Site Status

Site Reference ID/Investigator# 61258

North Hollywood, California, United States

Site Status

Site Reference ID/Investigator# 61265

Milford, Connecticut, United States

Site Status

Site Reference ID/Investigator# 61234

DeLand, Florida, United States

Site Status

Site Reference ID/Investigator# 61213

Ocala, Florida, United States

Site Status

Site Reference ID/Investigator# 61211

Oldsmar, Florida, United States

Site Status

Site Reference ID/Investigator# 61217

Orlando, Florida, United States

Site Status

Site Reference ID/Investigator# 61231

Plantation, Florida, United States

Site Status

Site Reference ID/Investigator# 61245

Tampa, Florida, United States

Site Status

Site Reference ID/Investigator# 61263

Marietta, Georgia, United States

Site Status

Site Reference ID/Investigator# 61210

Brockton, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 61260

Watertown, Massachusetts, United States

Site Status

Site Reference ID/Investigator# 61244

Florissant, Missouri, United States

Site Status

Site Reference ID/Investigator# 61266

St Louis, Missouri, United States

Site Status

Site Reference ID/Investigator# 61206

Omaha, Nebraska, United States

Site Status

Site Reference ID/Investigator# 61223

Salisbury, North Carolina, United States

Site Status

Site Reference ID/Investigator# 61273

Cincinnati, Ohio, United States

Site Status

Site Reference ID/Investigator# 61228

Oklahoma City, Oklahoma, United States

Site Status

Site Reference ID/Investigator# 61264

Portland, Oregon, United States

Site Status

Site Reference ID/Investigator# 61238

Duncansville, Pennsylvania, United States

Site Status

Site Reference ID/Investigator# 61205

Beaumont, Texas, United States

Site Status

Site Reference ID/Investigator# 61218

Bryan, Texas, United States

Site Status

Site Reference ID/Investigator# 61235

San Antonio, Texas, United States

Site Status

Site Reference ID/Investigator# 61232

Draper, Utah, United States

Site Status

Site Reference ID/Investigator# 61269

Franklin, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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M13-237

Identifier Type: -

Identifier Source: org_study_id

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