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

Purpose

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

Condition	Intervention	Phase
Osteoarthritis of the Knee	Drug: ABT-652 Drug: Placebo Drug: Naproxen	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Further study details as provided by AbbVie:

Primary Outcome Measures:

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)

Secondary Outcome Measures:

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

Enrollment:	322
Study Start Date:	September 2010
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Eligibility

Ages Eligible for Study:	40 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01207115

Hide Study Locations

Locations

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

Sponsors and Collaborators

AbbVie (prior sponsor, Abbott)

Investigators

Study Director:

Rachel Duan, MD

AbbVie

More Information

No publications provided

Responsible Party:	AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:	NCT01207115 History of Changes
Other Study ID Numbers:	M10-889
Study First Received:	September 21, 2010
Last Updated:	January 2, 2013
Health Authority:	Canada: Health Canada Chile: Instituto de Salud Publica de Chile Australia: Department of Health and Ageing Therapeutic Goods Administration United States: Food and Drug Administration

Additional relevant MeSH terms:

Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 22, 2013