Osteoarthritis of the Knee Clinical Trial
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
To compare the analgesic efficacy and safety of ABT-652 administered twice daily (BID) to placebo in subjects with osteoarthritis (OA) of the knee.
Status | Completed |
Enrollment | 322 |
Est. completion date | May 2011 |
Est. primary completion date | May 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 75 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Site Reference ID/Investigator# 41782 | Brisbane | |
Australia | Site Reference ID/Investigator# 41779 | Campsie, Sydney | |
Australia | Site Reference ID/Investigator# 41778 | Clayton | |
Australia | Site Reference ID/Investigator# 41785 | Fitzroy | |
Australia | Site Reference ID/Investigator# 41582 | Kogarah | |
Australia | Site Reference ID/Investigator# 41776 | Malvern East | |
Canada | Site Reference ID/Investigator# 41563 | Montreal | |
Canada | Site Reference ID/Investigator# 41566 | Newmarket | |
Canada | Site Reference ID/Investigator# 41565 | Pointe-Claire | |
Canada | Site Reference ID/Investigator# 41562 | Sainte-Foy, Quebec | |
Chile | Site Reference ID/Investigator# 41951 | Santiago | |
Puerto Rico | Site Reference ID/Investigator# 37183 | Caguas | |
Puerto Rico | Site Reference ID/Investigator# 37622 | Ponce | |
Puerto Rico | Site Reference ID/Investigator# 35966 | San Juan | |
Puerto Rico | Site Reference ID/Investigator# 37184 | Trujillo Alto | |
United States | Site Reference ID/Investigator# 37221 | Anaheim | California |
United States | Site Reference ID/Investigator# 37208 | Austin | Texas |
United States | Site Reference ID/Investigator# 37229 | Boynton Beach | Florida |
United States | Site Reference ID/Investigator# 37217 | Brooklyn Center | Minnesota |
United States | Site Reference ID/Investigator# 37222 | Burbank | California |
United States | Site Reference ID/Investigator# 37220 | Chandler | Arizona |
United States | Site Reference ID/Investigator# 35956 | Chino | California |
United States | Site Reference ID/Investigator# 37214 | Duncansville | Pennsylvania |
United States | Site Reference ID/Investigator# 37053 | La Mesa | California |
United States | Site Reference ID/Investigator# 37218 | Lomita | California |
United States | Site Reference ID/Investigator# 37227 | Milford | Connecticut |
United States | Site Reference ID/Investigator# 35959 | New York | New York |
United States | Site Reference ID/Investigator# 37209 | Ocala | Florida |
United States | Site Reference ID/Investigator# 37212 | Plantation | Florida |
United States | Site Reference ID/Investigator# 35953 | Richmond | Virginia |
United States | Site Reference ID/Investigator# 37211 | Salisbury | North Carolina |
United States | Site Reference ID/Investigator# 37213 | San Antonio | Texas |
United States | Site Reference ID/Investigator# 35961 | South Miami | Florida |
United States | Site Reference ID/Investigator# 37228 | St. Louis | Missouri |
United States | Site Reference ID/Investigator# 37223 | Tempe | Arizona |
United States | Site Reference ID/Investigator# 37215 | Tucson | Arizona |
United States | Site Reference ID/Investigator# 37207 | Valparaiso | Indiana |
United States | Site Reference ID/Investigator# 37205 | Wyomissing | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
AbbVie (prior sponsor, Abbott) |
United States, Australia, Canada, Chile, Puerto Rico,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 24-hour average pain score measured by Visual Analog Scale | Subject reported pain intensity measured by Visual Analog Scale (0-100) | 8 weeks | No |
Secondary | Western Ontario and McMaster (WOMAC™ ) Osteoarthritis subscales, Pain, Physical Function and Stiffness scores | Self administered, patient-centered, health status questionnaire | 8 weeks | No |
Secondary | Subject's Global Assessment of Arthritis Status | Subject reported assessment of arthritis status measured by Visual Analogue Scale (0-100) | 8 weeks | No |
Secondary | Brief Pain Inventory | Subject reported pain intensity and intereference (scale 0-10) | 8 weeks | No |
Secondary | SF-36v2™ Health Status Survey | 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 | No |
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