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

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

This study has been completed.

Study NCT00647231. Last updated on August 11, 2008. Information provided by Hisamitsu Pharmaceutical Co., Inc.

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

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

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

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 ^†

Interventional

Study Design ^†

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

Primary Outcome Measure ^†

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

Secondary Outcome Measure ^†

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

Condition ^†

Osteoarthritis, Knee

Intervention ^†

Drug: HKT-500 Topical Patch

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

300

Start Date ^†

March 2008

Completion Date

August 2008

Eligibility Criteria ^†

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 ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00647231

Organization ID

HKT-500-US12

Secondary IDs ^††

Study Sponsor ^†

Hisamitsu Pharmaceutical Co., Inc.

Collaborators ^††

Investigators ^†

Study Director:

Kenichi Furuta

Hisamitsu

Information Provided By

Hisamitsu Pharmaceutical Co., Inc.

Verification Date

August 2008

First Received Date ^†

March 26, 2008

Last Updated Date

August 11, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.