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HKT-500 in Adult Patients With Shoulder Pain

NCT ID: NCT00680472

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

PHASE3

Total Enrollment

368 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

HKT-500 Ketoprofen Topical Patch

Intervention Type DRUG

HKT-500 Ketoprofen Topical Patch

A,2 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 Ketoprofen Topical Patch

HKT-500 Ketoprofen Topical Patch

Intervention Type DRUG

Placebo Patch

Treatment with Placebo Patch

Intervention Type OTHER

Other Intervention Names

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Ketoprofen Topical Patch Sham treatment

Eligibility Criteria

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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.
Minimum Eligible Age

18 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 Pharmaceutical Co., Inc.

Locations

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Hisamitsu Investigator Site

Birmingham, Alabama, United States

Site Status

Hisamitsu Investigator Site

Tempe, Arizona, United States

Site Status

Hisamitsu Investigator Site

Fullerton, California, United States

Site Status

Hisamitsu Investigator Site

Denver, Colorado, United States

Site Status

Hisamitsu Investigator Site

Washington D.C., District of Columbia, United States

Site Status

Hisamitsu Investigator Site

Bradenton, Florida, United States

Site Status

Hisamitsu Investigator Site

Chiefland, Florida, United States

Site Status

Hisamitsu Investigator Site

DeLand, Florida, United States

Site Status

Hisamitsu Investigator Site

Delray Beach, Florida, United States

Site Status

Hisamitsu Investigator Site

Dunedin, Florida, United States

Site Status

Hisamitsu Investigator Site

Longwood, Florida, United States

Site Status

Hisamitsu Investigator Site

Oldsmar, Florida, United States

Site Status

Hisamitsu Pharmaceutical Co., Inc.

Orange City, Florida, United States

Site Status

Hisamitsu Investigator Site

Plantation, Florida, United States

Site Status

Hisamitsu Investigator Site

Tampa, Florida, United States

Site Status

Hisamitsu Investigator Site

Tampa, Florida, United States

Site Status

Hisamitsu Investigator Site

Blue Ridge, Georgia, United States

Site Status

Hisamitsu Investigator Site

Boise, Idaho, United States

Site Status

Hisamitsu Investigator Site

Wichita, Kansas, United States

Site Status

Hisamitsu Investigator Site

Paducah, Kentucky, United States

Site Status

Hisamitsu Investigator Site

Bowie, Maryland, United States

Site Status

Hisamitsu Investigator Site

Kalamazoo, Michigan, United States

Site Status

Hisamitsu Investigator Site

Bridgewater, New Jersey, United States

Site Status

Hisamitsu Investigator Site

Cary, North Carolina, United States

Site Status

HIsamitsu Pharmaceutical Co., Inc.

Durham, North Carolina, United States

Site Status

Hisamitsu Investigator Site

Raleigh, North Carolina, United States

Site Status

Hisamitsu Investigator Site

Fargo, North Dakota, United States

Site Status

Hisamitsu Investigator Site

Fargo, North Dakota, United States

Site Status

HIsamitsu Pharmaceutical Co., Inc.

Perrysburg, Ohio, United States

Site Status

Hisamitsu Investigator Site

Toledo, Ohio, United States

Site Status

Hisamitsu Investigator Site

Zanesville, Ohio, United States

Site Status

Hisamitsu Investigator Site

New Tazewell, Tennessee, United States

Site Status

Hisamitsu Investigator Site

Bryan, Texas, United States

Site Status

Hisamitsu Investigator Site

San Antonio, Texas, United States

Site Status

Hisamitsu Investigator Site

Newport News, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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HKT-500-US08

Identifier Type: -

Identifier Source: org_study_id

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