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

• Status: Completed
• Trial end date: 2008-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hisamitsu Pharmaceutical Co., Inc.
• Treatments: Ketoprofen

Criteria

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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