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NCT00647231 Clinical Trial

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

Osteoarthritis, Knee Clinical Trial

Official title:
Protocol HKT-500-US12: 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00647231
Other study ID # HKT-500-US12
Secondary ID
Status Completed
Phase Phase 2
First received March 26, 2008
Last updated May 12, 2015
Start date March 2008
Est. completion date August 2008

Study information
Verified date May 2015
Source Hisamitsu Pharmaceutical Co., Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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

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 information / eligibility
Status Completed
Enrollment 300
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 45 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

Intervention

Drug:
• HKT-500 Topical Patch
Treatment with Ketoprofen Topical Patch
Other:
• Placebo Patch
Treatment with placebo patch

Locations
Country Name City State
United States Hisamitsu Investigator Site Austell Georgia
United States Hisamitsu Investigator Site Baton Rouge Louisiana
United States Hisamitsu Investigator Site Berlin New Jersey
United States Hisamitsu Investigator Site Birmingham Alabama
United States Hisamitsu Investigator Site Burbank California
United States Hisamitsu Investigator Site Chicago Illinois
United States Hisamitsu Investigator Site Cincinnati Ohio
United States Hisamitsu Investigator Site Colorado Springs Colorado
United States Hisamitsu Investigator Site Deland Florida
United States Hisamitsu Investigator Site Duncansville Pennsylvania
United States Hisamitsu Investigator Site Escondido California
United States Hisamitsu Investigator Site Flint Michigan
United States Hisamitsu Investigator Site Hallandale Beach Florida
United States Hisamitsu Investigator Site Houston Texas
United States Hisamitsu Investigator Site Lake Charles Louisiana
United States Hisamitsu Investigator Site Little Rock Arkansas
United States Hisamitsu Investigator Site Little Rock Arkansas
United States Hisamitsu Investigator Site Madisonville Kentucky
United States Hisamitsu Investigator Site Northridge California
United States Hisamitsu Investigator Site Ocala Florida
United States Hisamitsu Investigator Site Oklahoma City Oklahoma
United States Hisamitsu Investigator Site Omaha Nebraska
United States Hisamitsu Investigator Site Ormond Beach Florida
United States Hisamitsu Investigator Site Phoenix Arizona
United States Hisamitsu Investigator Site Raleigh North Carolina
United States Hisamitsu Investigator Site Salt Lake City Utah
United States Hisamitsu Investigator Site Savannah Georgia
United States Hisamitsu Investigator Site Stockbridge Georgia
United States Hisamitsu Investigator Site Zanesville Ohio

Sponsors (1)
Lead Sponsor Collaborator
Hisamitsu Pharmaceutical Co., Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time to Onset and Duration 36 hours No
Secondary Outcome Time Frame 36 hours No
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