HKT-500 in Adult Patients With Ankle Sprain

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00680784

Enrollment

260

Registered

2008-05-20

Start date

2008-04-30

Completion date

2008-11-30

Last updated

2015-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ankle Sprain

Keywords

sprain, ankle, pain

Brief summary

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

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.

Interventions

DRUGHKT-500 Ketoprofen Topical Patch

HKT-500 Ketoprofen Topical Patch

OTHERPlacebo Patch

Placebo Patch

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Pain Assessment	2 Weeks

Secondary

Measure	Time frame
Safety Assessment	2 Weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026