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

NCT ID: NCT00647231

Last Updated: 2015-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-08-31

Brief Summary

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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

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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

Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A, 2, II, HKT-500 Topical Patch

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

Group Type EXPERIMENTAL

HKT-500 Topical Patch

Intervention Type DRUG

Treatment with Ketoprofen Topical Patch

Placebo Patch

Treatment with placebo patch

Group Type PLACEBO_COMPARATOR

Placebo Patch

Intervention Type OTHER

Treatment with placebo patch

Interventions

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HKT-500 Topical Patch

Treatment with Ketoprofen Topical Patch

Intervention Type DRUG

Placebo Patch

Treatment with placebo patch

Intervention Type OTHER

Other Intervention Names

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Sham tratment HKT-500 Ketoprofen

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hisamitsu Pharmaceutical Co., Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenichi Furuta

Role: STUDY_DIRECTOR

Hisamitsu

Locations

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Hisamitsu Investigator Site

Birmingham, Alabama, United States

Site Status

Hisamitsu Investigator Site

Phoenix, Arizona, United States

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Hisamitsu Investigator Site

Little Rock, Arkansas, United States

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Hisamitsu Investigator Site

Little Rock, Arkansas, United States

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Hisamitsu Investigator Site

Burbank, California, United States

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Hisamitsu Investigator Site

Escondido, California, United States

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Hisamitsu Investigator Site

Northridge, California, United States

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Hisamitsu Investigator Site

Colorado Springs, Colorado, United States

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Hisamitsu Investigator Site

DeLand, Florida, United States

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Hisamitsu Investigator Site

Hallandale, Florida, United States

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Hisamitsu Investigator Site

Ocala, Florida, United States

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Hisamitsu Investigator Site

Ormond Beach, Florida, United States

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Hisamitsu Investigator Site

Austell, Georgia, United States

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Hisamitsu Investigator Site

Savannah, Georgia, United States

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Hisamitsu Investigator Site

Stockbridge, Georgia, United States

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Hisamitsu Investigator Site

Chicago, Illinois, United States

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Hisamitsu Investigator Site

Madisonville, Kentucky, United States

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Hisamitsu Investigator Site

Baton Rouge, Louisiana, United States

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Hisamitsu Investigator Site

Lake Charles, Louisiana, United States

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Hisamitsu Investigator Site

Flint, Michigan, United States

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Hisamitsu Investigator Site

Omaha, Nebraska, United States

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Hisamitsu Investigator Site

Berlin, New Jersey, United States

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Hisamitsu Investigator Site

Raleigh, North Carolina, United States

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Hisamitsu Investigator Site

Cincinnati, Ohio, United States

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Hisamitsu Investigator Site

Zanesville, Ohio, United States

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Hisamitsu Investigator Site

Oklahoma City, Oklahoma, United States

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Hisamitsu Investigator Site

Duncansville, Pennsylvania, United States

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Hisamitsu Investigator Site

Houston, Texas, United States

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Hisamitsu Investigator Site

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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HKT-500-US12

Identifier Type: -

Identifier Source: org_study_id

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