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Completed

NCT Number: NCT00680784

HKT-500 in Adult Patients With Ankle Sprain

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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Key information

Conditions

Ankle Sprain Ankle Injuries Leg Injuries Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hisamitsu Investigator Site., Birmingham, Alabama, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HKT-500 Ketoprofen Topical Patch

Drug

HKT-500 Ketoprofen Topical Patch

Other names: Ketoprofen Topical Patch

Placebo patch

Other

Placebo Patch

Other names: Sham treatment

Primary outcomes

  1. Pain Assessment

    Time frame: 2 Weeks

Secondary outcomes

  1. Safety Assessment

    Time frame: 2 Weeks

Sponsors and collaborators

Lead sponsor

Hisamitsu Pharmaceutical Co., Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 20, 2008
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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