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

May 12, 2015 updated by: Hisamitsu Pharmaceutical Co., Inc.

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Hisamitsu Investigator Site
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Hisamitsu Investigator Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Hisamitsu Investigator Site
      • Little Rock, Arkansas, United States, 72211
        • Hisamitsu Investigator Site
    • California
      • Burbank, California, United States, 91505
        • Hisamitsu Investigator Site
      • Escondido, California, United States, 92025
        • Hisamitsu Investigator Site
      • Northridge, California, United States, 91325
        • Hisamitsu Investigator Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Hisamitsu Investigator Site
    • Florida
      • Deland, Florida, United States, 32720
        • Hisamitsu Investigator Site
      • Hallandale Beach, Florida, United States, 33009
        • Hisamitsu Investigator Site
      • Ocala, Florida, United States, 34474
        • Hisamitsu Investigator Site
      • Ormond Beach, Florida, United States, 32174
        • Hisamitsu Investigator Site
    • Georgia
      • Austell, Georgia, United States, 30106
        • Hisamitsu Investigator Site
      • Savannah, Georgia, United States, 31405
        • Hisamitsu Investigator Site
      • Stockbridge, Georgia, United States, 30281
        • Hisamitsu Investigator Site
    • Illinois
      • Chicago, Illinois, United States, 60616
        • Hisamitsu Investigator Site
    • Kentucky
      • Madisonville, Kentucky, United States, 42431
        • Hisamitsu Investigator Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Hisamitsu Investigator Site
      • Lake Charles, Louisiana, United States, 70601
        • Hisamitsu Investigator Site
    • Michigan
      • Flint, Michigan, United States, 48504
        • Hisamitsu Investigator Site
    • Nebraska
      • Omaha, Nebraska, United States, 68114
        • Hisamitsu Investigator Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Hisamitsu Investigator Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Hisamitsu Investigator Site
    • Ohio
      • Cincinnati, Ohio, United States, 45206
        • Hisamitsu Investigator Site
      • Zanesville, Ohio, United States, 43701
        • Hisamitsu Investigator Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Hisamitsu Investigator Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Hisamitsu Investigator Site
    • Texas
      • Houston, Texas, United States, 77074
        • Hisamitsu Investigator Site
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Hisamitsu Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: FACTORIAL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Drug: HKT-500 Topical Patch
Treatment with Ketoprofen Topical Patch
Other Names:
  • HKT-500
  • Ketoprofen
PLACEBO_COMPARATOR: Placebo Patch
Treatment with placebo patch
Other: Placebo Patch
Treatment with placebo patch
Other Names:
  • Sham tratment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Onset and Duration
Time Frame: 36 hours
36 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Outcome Time Frame
Time Frame: 36 hours
36 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hisamitsu Pharmaceutical Co., Inc.

Investigators

  • Study Director: Kenichi Furuta, Hisamitsu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

August 1, 2008

Study Completion (ACTUAL)

August 1, 2008

Study Registration Dates

First Submitted

March 26, 2008

First Submitted That Met QC Criteria

March 28, 2008

First Posted (ESTIMATE)

March 31, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2015

Last Update Submitted That Met QC Criteria

May 12, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HKT-500-US12

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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