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

Completed · Phase 2 · Has a placebo group

Conditions studied: Osteoarthritis of the Knee

In brief

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

Key facts

Study ID

NCT01207115

Run by

AbbVie (prior sponsor, Abbott)

People needed

322

Starts

2010-09-01

Expected to finish

2011-05-01

Last updated by the study team

2013-01-07

Who can join

Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Site Reference ID/Investigator# 37220 — Chandler, Arizona, United States
• Site Reference ID/Investigator# 37223 — Tempe, Arizona, United States
• Site Reference ID/Investigator# 37215 — Tucson, Arizona, United States
• Site Reference ID/Investigator# 37221 — Anaheim, California, United States
• Site Reference ID/Investigator# 37222 — Burbank, California, United States
• Site Reference ID/Investigator# 35956 — Chino, California, 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# 37229 — Boynton Beach, Florida, United States
• Site Reference ID/Investigator# 37209 — Ocala, Florida, United States
• Site Reference ID/Investigator# 37212 — Plantation, Florida, United States
• Site Reference ID/Investigator# 35961 — South Miami, Florida, United States
• Site Reference ID/Investigator# 37207 — Valparaiso, Indiana, United States
• Site Reference ID/Investigator# 37217 — Brooklyn Center, Minnesota, United States
• Site Reference ID/Investigator# 37228 — St Louis, Missouri, United States
• Site Reference ID/Investigator# 35959 — New York, New York, United States
• Site Reference ID/Investigator# 37211 — Salisbury, North Carolina, United States
• Site Reference ID/Investigator# 37214 — Duncansville, Pennsylvania, United States
• Site Reference ID/Investigator# 37205 — Wyomissing, Pennsylvania, United States
• Site Reference ID/Investigator# 37208 — Austin, Texas, United States
• Site Reference ID/Investigator# 37213 — San Antonio, Texas, United States
• Site Reference ID/Investigator# 35953 — Richmond, Virginia, United States
• Site Reference ID/Investigator# 41782 — Brisbane, Australia
• Site Reference ID/Investigator# 41779 — Campsie, Sydney, Australia

Full record on ClinicalTrials.gov

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