HKT-500 in Adult Patients With Ankle Sprain

This study has been completed.
Information provided by (Responsible Party):
Hisamitsu Pharmaceutical Co., Inc. Identifier:
First received: May 16, 2008
Last updated: February 24, 2014
Last verified: February 2014

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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
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

Resource links provided by NLM:

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

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.


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

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 identifier: NCT00680784

  Show 30 Study Locations
Sponsors and Collaborators
Hisamitsu Pharmaceutical Co., Inc.
Study Director: Kenichi Furuta Hisamitsu Pharmaceutical Co., Inc.
  More Information

No publications provided

Responsible Party: Hisamitsu Pharmaceutical Co., Inc. Identifier: NCT00680784     History of Changes
Other Study ID Numbers: HKT-500-US10
Study First Received: May 16, 2008
Last Updated: February 24, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Hisamitsu Pharmaceutical Co., Inc.:

Additional relevant MeSH terms:
Sprains and Strains
Ankle Injuries
Wounds and Injuries
Leg Injuries
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents processed this record on April 17, 2014