Status:
COMPLETED
HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain
Lead Sponsor:
Hisamitsu Pharmaceutical Co., Inc.
Conditions:
Osteoarthritis of the Knee
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief Summary
Ketoprofen in a topical patch formulation has been demonstrated to be effective for treating mild to moderate pain caused by various musculoskeletal disorders.
Detailed Description
The objective of this study is to demonstrate the short-term multiple dose efficacy and safety of HKT-500 in subjects with pain caused by mild to moderate osteoarthritis of the knee. The goal of the s...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
380 Patients enrolled
Trial Details
Trial ID
NCT00792727
Start Date
September 1 2007
End Date
May 1 2008
Last Update
June 4 2015
Active Locations (36)
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1
Hisamitsu Investigator Site
Birmingham, Alabama, United States, 35242
2
Hisamitsu Investigator Site
Chandler, Arizona, United States, 85225
3
Hisamitsu Investigator Site
Peoria, Arizona, United States, 85381
4
Hisamitsu Investigator Site
San Diego, California, United States, 92108