HKT-500 in Adult Patients With Ankle Sprain - Full Text View

Sponsored by:	Hisamitsu Pharmaceutical Co., Inc.
Information provided by:	Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier:	NCT00680784

Purpose

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

Condition	Intervention	Phase
Ankle Sprain	Drug: HKT-500 & Ketoprofen Topical Patch Drug: placebo	Phase III

Drug Information available for: Ketoprofen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Protocol HKT-500-US10: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Grade I or Grade II Ankle Sprain

Further study details as provided by Hisamitsu Pharmaceutical Co., Inc.:

Primary Outcome Measures:

Pain Assessment [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety Assessment [ Time Frame: 2 Weeks ] [ Designated as safety issue: Yes ]

Enrollment:	260
Study Start Date:	April 2008
Study Completion Date:	November 2008
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental A Randomized, Multi-Center, Double-Blind	Drug: HKT-500 & Ketoprofen Topical Patch HKT-500 & Ketoprofen Topical Patch
2: Placebo Comparator	Drug: placebo placebo

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680784

Show 30 Study Locations

Sponsors and Collaborators

Hisamitsu Pharmaceutical Co., Inc.

Investigators

Study Director:

Kenichi Furuta

Hisamitsu Pharmaceutical Co., Inc.

More Information

Responsible Party:	Hisamitsu Pharmaceitical Co., Inc. ( Mr. Kenichi Furuta, General Manager, International Development Dept )
Study ID Numbers:	HKT-500-US10
Study First Received:	May 16, 2008
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00680784
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hisamitsu Pharmaceutical Co., Inc.:

sprain
ankle
pain

Study placed in the following topic categories:

Ketoprofen
Wounds and Injuries
Disorders of Environmental Origin
Pain
Sprains and Strains

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 14, 2009