NCT00792727

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

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Four-Week Study to Assess the Efficacy and Safety of HKT-500 in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 380 (actual)
• Sponsor: Hisamitsu Pharmaceutical Co., Inc. · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

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 study is to gather additional information about the analgesic efficacy and safety of repeated, 24-hour applications of 2 HKT-500 patches per knee for a total of 28 days in subjects with pain caused by mild to moderate osteoarthritis of the knee.

Conditions

• Osteoarthritis of the Knee

Interventions

Type	Name	Description
DRUG	ketoprofen Patch	2 topical patches applied once daily for 28 days
OTHER	Placebo Patch	2 topical placebo patches applied once daily for 28 days

Timeline

• Start date: 2007-09-01
• Primary completion: 2008-04-01
• Completion: 2008-05-01
• First posted: 2008-11-18
• Last updated: 2015-06-04

Locations

36 sites across 1 country: United States