HKT-500 in Adult Patients With Shoulder Pain (Pain)

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

Protocol HKT-500-US08: A Randomized, Multicenter, Double-blind, Placebo-controlled, Two-week Study to Assess the Efficacy and Safety of HKT-500 in Subjects With Acute Shoulder Pain

The objective of this study is to determine the efficacy of HKT-500 in subjects with acute shoulder pain

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or greater who have acute shoulder pain requiring analgesic treatment daily for at least 2 weeks.

Study Type

Interventional

Enrollment (Actual)

368

Phase

  • Phase 3

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
      • Tempe, Arizona, United States, 85283
        • Hisamitsu Investigator Site
    • California
      • Fullerton, California, United States, 92835
        • Hisamitsu Investigator Site
    • Colorado
      • Denver, Colorado, United States, 80204
        • Hisamitsu Investigator Site
    • District of Columbia
      • Washington, District of Columbia, United States, 20003
        • Hisamitsu Investigator Site
    • Florida
      • Bradenton, Florida, United States, 34209
        • Hisamitsu Investigator Site
      • Chiefland, Florida, United States, 32626
        • Hisamitsu Investigator Site
      • DeLand, Florida, United States, 32720
        • Hisamitsu Investigator Site
      • Delray Beach, Florida, United States, 33484
        • Hisamitsu Investigator Site
      • Dunedin, Florida, United States, 34698
        • Hisamitsu Investigator Site
      • Longwood, Florida, United States, 32779
        • Hisamitsu Investigator Site
      • Oldsmar, Florida, United States, 34677
        • Hisamitsu Investigator Site
      • Orange City, Florida, United States, 32763
        • Hisamitsu Pharmaceutical Co., Inc.
      • Plantation, Florida, United States, 33324
        • Hisamitsu Investigator Site
      • Tampa, Florida, United States, 33603
        • Hisamitsu Investigator Site
      • Tampa, Florida, United States, 33609
        • Hisamitsu Investigator Site
    • Georgia
      • Blue Ridge, Georgia, United States, 30513
        • Hisamitsu Investigator Site
    • Idaho
      • Boise, Idaho, United States, 83702
        • Hisamitsu Investigator Site
    • Kansas
      • Wichita, Kansas, United States, 67205
        • Hisamitsu Investigator Site
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Hisamitsu Investigator Site
    • Maryland
      • Bowie, Maryland, United States, 20716
        • Hisamitsu Investigator Site
    • Michigan
      • Kalamazoo, Michigan, United States, 49009
        • Hisamitsu Investigator Site
    • New Jersey
      • Bridgewater, New Jersey, United States, 08807
        • Hisamitsu Investigator Site
    • North Carolina
      • Cary, North Carolina, United States, 27513
        • Hisamitsu Investigator Site
      • Durham, North Carolina, United States, 27704
        • Hisamitsu Pharmaceutical Co., Inc.
      • Raleigh, North Carolina, United States, 27615
        • Hisamitsu Investigator Site
    • North Dakota
      • Fargo, North Dakota, United States, 58104
        • Hisamitsu Investigator Site
      • Fargo, North Dakota, United States, 58108
        • Hisamitsu Investigator Site
    • Ohio
      • Perrysburg, Ohio, United States, 43551
        • Hisamitsu Pharmaceutical Co., Inc.
      • Toledo, Ohio, United States, 43623
        • Hisamitsu Investigator Site
      • Zanesville, Ohio, United States, 43701
        • Hisamitsu Investigator Site
    • Tennessee
      • New Tazewell, Tennessee, United States, 37825
        • Hisamitsu Investigator Site
    • Texas
      • Bryan, Texas, United States, 77802
        • Hisamitsu Investigator Site
      • San Antonio, Texas, United States, 78217
        • Hisamitsu Investigator Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • 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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • The subject has unilateral acute shoulder pain.

Exclusion Criteria:

  • The subject is a women of childbearing potential who has a positive urine pregnancy test, or who is lactating, or who is not surgically sterile (by tubal ligation or hysterectomy), or at least 2 years postmenopausal, and has not practiced an acceptable form of birth control (defined as the use of an intrauterine device with spermicide, a barrier method with spermicide, condoms with spermicide, subdermal implant, oral contraceptives, or abstinence) for at least 2 months prior to Visit 1.

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

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A,1 HKT-500 Ketoprofen Topical Patch
A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Two-Week Study to Assess the Efficacy and Safety of HKT-500 in Subjects with Acute Shoulder Pain
Drug: HKT-500 Ketoprofen Topical Patch
HKT-500 Ketoprofen Topical Patch
Other Names:
  • Ketoprofen Topical Patch
PLACEBO_COMPARATOR: A,2 Placebo Patch
Treatment with placebo patch
Other: Placebo Patch
Treatment with Placebo Patch
Other Names:
  • Sham treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain Assessment
Time Frame: 2 Weeks
2 Weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Safety Assessment
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

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

Sponsor

Hisamitsu Pharmaceutical Co., Inc.

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

April 1, 2008

Primary Completion (ACTUAL)

October 1, 2008

Study Completion (ACTUAL)

October 1, 2008

Study Registration Dates

First Submitted

May 16, 2008

First Submitted That Met QC Criteria

May 19, 2008

First Posted (ESTIMATE)

May 20, 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-US08

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.

Clinical Trials on Pain

Clinical Trials on HKT-500 Ketoprofen Topical Patch

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe