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HKT-500 in Adult Patients With Ankle Sprain

NCT ID: NCT00680784

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

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2008-11-30

Brief Summary

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The objective of this study is to demonstrate the multiple-dose efficacy and safety of HKT-500 for the treatment of ankle sprain.

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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 older who have a painful, acute, benign, ankle sprain of the lateral ligament(s) within the previous 48 hours.

Conditions

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Ankle Sprain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HKT-500 Ketoprofen Topical Patch

Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or older who have a painful, acute, benign, ankle sprain of the lateral ligament(s) within the previous 48 hours.

Group Type EXPERIMENTAL

HKT-500 Ketoprofen Topical Patch

Intervention Type DRUG

HKT-500 Ketoprofen Topical Patch

Placebo Patch

Treatment with placebo patch

Group Type PLACEBO_COMPARATOR

Placebo Patch

Intervention Type OTHER

Placebo Patch

Interventions

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HKT-500 Ketoprofen Topical Patch

HKT-500 Ketoprofen Topical Patch

Intervention Type DRUG

Placebo Patch

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

* Grade I or Grade II Ankle Sprain.

Exclusion Criteria

* The subject is a women of childbearing potential who has a positive urine pregnancy test, who is lactating, who is not surgically sterile (by tubal ligation or hysterectomy), or at least 2 years postmenopausal, and has not practice 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.

Birmingham, Alabama, United States

Site Status

Hisamitsu Investigator Site.

Montgomery, Alabama, United States

Site Status

Hisamitsu Investigator Site.

Anaheim, California, United States

Site Status

Hisamitsu Investigator Site.

San Luis Obispo, California, United States

Site Status

Hisamitsu Investigator Site.

Colorado Springs, Colorado, United States

Site Status

Hisamitsu Investigator Site.

Kissimmee, Florida, United States

Site Status

Hisamitsu Investigator Site.

Oldsmar, Florida, United States

Site Status

Hisamitsu Investigator Site.

Pembroke Pines, Florida, United States

Site Status

Hisamitsu Investigator Site.

South Miami, Florida, United States

Site Status

Hisamitsu Investigator Site.

Blue Ridge, Georgia, United States

Site Status

Hisamitsu Investigator Site.

Chicago, Illinois, United States

Site Status

Hisamitsu Investigator Site.

Paducah, Kentucky, United States

Site Status

Hisamitsu Investigator Site.

Pasadena, Maryland, United States

Site Status

Hisamitsu Investigator Site.

Benzonia, Michigan, United States

Site Status

Hisamitsu Investigator Site.

Cadillac, Michigan, United States

Site Status

Hisamitsu Investigator Site.

Interlochen, Michigan, United States

Site Status

Hisamitsu Investigator Site.

Kalamazoo, Michigan, United States

Site Status

Hisamitsu Investigator Site.

Omaha, Nebraska, United States

Site Status

Hisamitsu Investigator Site.

South Bound Brook, New Jersey, United States

Site Status

Hisamitsu Investigator Site.

Albuquerque, New Mexico, United States

Site Status

Hisamitsu Investigator Site.

New York, New York, United States

Site Status

Hisamitsu Investigator Site.

Fargo, North Dakota, United States

Site Status

Hisamitsu Investigator Site.

Zanesville, Ohio, United States

Site Status

Hisamitsu Investigator Site.

Altoona, Pennsylvania, United States

Site Status

Hisamitsu Investigator Site.

Feasterville, Pennsylvania, United States

Site Status

Hisamitsu Investigator Site.

Morrisville, Pennsylvania, United States

Site Status

Hisamitsu Investigator Site.

Norristown, Pennsylvania, United States

Site Status

Hisamitsu Investigator Site.

Houston, Texas, United States

Site Status

Hisamitsu Investigator Site.

Bellevue, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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HKT-500-US10

Identifier Type: -

Identifier Source: org_study_id

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