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

Tracking Information

First Received Date ^ICMJE

March 26, 2008

Last Updated Date

August 11, 2008

Start Date ^ICMJE

March 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Time to Onset and Duration [ Time Frame: 36 hours ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00647231 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Outcome Time Frame [ Time Frame: 36 hours ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Other, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment

Condition ^ICMJE

Osteoarthritis, Knee

Intervention ^ICMJE

Drug: HKT-500 Topical Patch

Study Arms / Comparison Groups

Experimental: A Randomized,Multi-Center, Double-Blind, Single Dose,

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

300

Completion Date

August 2008

Primary Completion Date

August 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

45 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00647231

Responsible Party

Mr. Kenichi Furuta, General Manager, International Development Dept., Hisamitsu Pharmaceutical Co., Inc.

Study ID Numbers ^ICMJE

HKT-500-US12

Study Sponsor ^ICMJE

Hisamitsu Pharmaceutical Co., Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Kenichi Furuta

Hisamitsu

Information Provided By

Hisamitsu Pharmaceutical Co., Inc.

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP