HKT-500-US12 In Adult Patients With OA Knee Pain
Phase 2
Completed
- Conditions
- Osteoarthritis, Knee
- Interventions
- Drug: HKT-500 Topical PatchOther: Placebo Patch
- Registration Number
- NCT00647231
- Lead Sponsor
- Hisamitsu Pharmaceutical Co., Inc.
- Brief Summary
The objective of this study is to characterize the analgesic properties of single dose study of HKT-500 in subjects with pain caused by mild to moderate OA of the knee
- Detailed Description
A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects with Pain Caused by Mild to Moderate Osteoarthritis of the Knee
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
Inclusion Criteria
- male or female 45 years of age or older
- with osteoarthritis of the knee
Exclusion Criteria
- subject is a woman of childbearing potential
- who has a positive urine pregnancy test,
- is lactating, or who is not surgically sterile
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description A, 2, II, HKT-500 Topical Patch HKT-500 Topical Patch A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee Placebo Patch Placebo Patch Treatment with placebo patch
- Primary Outcome Measures
Name Time Method Time to Onset and Duration 36 hours
- Secondary Outcome Measures
Name Time Method Outcome Time Frame 36 hours
Trial Locations
- Locations (1)
Hisamitsu Investigator Site
🇺🇸Salt Lake City, Utah, United States