HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain

Completed · Phase 3 · Has a placebo group

Conditions studied: Osteoarthritis of the Knee

In brief

Ketoprofen in a topical patch formulation has been demonstrated to be effective for treating mild to moderate pain caused by various musculoskeletal disorders.

Key facts

Study ID

NCT00792727

Run by

Hisamitsu Pharmaceutical Co., Inc.

People needed

380

Starts

2007-09-01

Expected to finish

2008-05-01

Last updated by the study team

2015-06-04

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• man or woman ≥45 years of age.
• clinical diagnosis of unilateral or bilateral OA of the knee
• taking an NSAID or acetaminophen on a regular basis and has a history of knee pain amelioration with NSAID or acetaminophen use.
• mild to moderate OA of the knee at the screening visit
• subject exhibits an arthritis "flare" in the target knee within 7 days day of withdrawing from a NSAID or acetaminophen.
• subject understands that treatment will be administered on an inpatient basis.
• subject is capable of understanding and complying with the protocol and has signed the informed consent document.

You may not qualify if…

• subject is a woman of childbearing potential who has a positive urine pregnancy test, is lactating, or who is not surgically sterile
• subject has symptoms that are attributable to primary inflammatory diseases of the joint
• subject has unstable knees including a history of the knee catching or giving way or physical examination evidence of instability
• subject has arthropathies that occur in conjunction with systemic diseases
• subject has a chronic pain condition
• subject is grossly obese
• subject has a history of knee surgery within the past 12 months or arthroscopy within the past 6 months.
• subject has a history of osteotomies.
• subject is not willing to discontinue the use of NSAIDs, acetaminophen or other prohibited treatments
• subject used opioids for OA pain within 1 month

Where it is running

• Hisamitsu Investigator Site — Birmingham, Alabama, United States
• Hisamitsu Investigator Site — Chandler, Arizona, United States
• Hisamitsu Investigator Site — Peoria, Arizona, United States
• Hisamitsu Investigator Site — San Diego, California, United States
• Hisamitsu Investigator Site — Colorado Springs, Colorado, United States
• Hisamitsu Investigator Site — Denver, Colorado, United States
• Hisamitsu Investigator Site — Denver, Colorado, United States
• Hisamitsu Investigator Site — Daytona Beach, Florida, United States
• Hisamitsu Investigator Site — Delray Beach, Florida, United States
• Hisamitsu Investigator Site — Fort Myers, Florida, United States
• Hisamitsu Investigator Site — Pembroke Pines, Florida, United States
• Hisamitsu Investigator Site — Evansville, Indiana, United States
• Hisamitsu Investigator Site — Crestview Hills, Kentucky, United States
• Hisamitsu Investigator Site — Fall River, Massachusetts, United States
• Hisamitsu Investigator Site — Omaha, Nebraska, United States
• Hisamitsu Investigator Site — Las Vegas, Nevada, United States
• Hisamitsu Investigator Site — Reno, Nevada, United States
• Hisamitsu Investigator Site — Albuquerque, New Mexico, United States
• Hisamitsu Investigator Site — Greensboro, North Carolina, United States
• Hisamitsu Investigator Site — Bismarck, North Dakota, United States
• Hisamitsu Investigator Site — Cincinnati, Ohio, United States
• Hisamitsu Investigator Site — Columbus, Ohio, United States
• Hisamitsu Investigator Site — Mogadore, Ohio, United States
• Hisamitsu Investigator Site — Zanesville, Ohio, United States
• Hisamitsu Investigator Site — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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