HKT-500-US12 In Adult Patients With OA Knee Pain

Hisamitsu Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Osteoarthritis, Knee

Treatments: Other: Placebo Patch; Drug: HKT-500 Topical Patch

Study type: Interventional

Funder types: Industry

Identifiers

NCT00647231

HKT-500-US12

Details and patient eligibility

About

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

Full 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

Enrollment: 300 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 2 patient groups, including a placebo group

A, 2, II, HKT-500 Topical Patch

Experimental group

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

Treatment:

Drug: HKT-500 Topical Patch

Placebo Patch

Placebo Comparator group

Description:

Treatment with placebo patch

Treatment:

Other: Placebo Patch