MedDataX Logo

HKT-500 in the Treatment of Adult Patients With Ankle Sprain

NCT ID: NCT00927641

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

HKT-500 in Adult Patients With Ankle Sprain

NCT00680784

Ankle Sprain
COMPLETED PHASE3

HKT-500 in Adult Patients With Shoulder Pain

NCT00680472

Pain
COMPLETED PHASE3

Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Ankle Sprain or Strain

NCT00351104

Sprain Strain
COMPLETED PHASE3

FS-67 in the Treatment of Pediatric Patients With Ankle Sprain

NCT01037816

Ankle Sprain
COMPLETED PHASE4

Efficacy of Topical Indomethacin Patch Over Placebo in Ankle Sprain Pain Relief

NCT01957215

Ankle Sprain
COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Mild to Moderate Ankle Sprain

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ankle Sprain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ketoprofen Patch (HKT-500)

Two Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days

Group Type ACTIVE_COMPARATOR

Ketoprofen Patch

Intervention Type DRUG

Two Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days

Placebo Patch

Two placebo patches placed on target ankle once daily for 14 days

Group Type PLACEBO_COMPARATOR

Placebo Patch

Intervention Type OTHER

Two placebo patches placed on target ankle once daily for 14 days

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ketoprofen Patch

Two Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days

Intervention Type DRUG

Placebo Patch

Two placebo patches placed on target ankle once daily for 14 days

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Topical Patch Sham treatment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* mild to Moderate Ankle Sprain

Exclusion Criteria

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

Meet the organizations funding or collaborating on the study and learn about their roles.

Hisamitsu Pharmaceutical Co., Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hisamitsu Investigator Site

Birmingham, Alabama, United States

Site Status

Hisamitsu Investigator Site

Phoenix, Arizona, United States

Site Status

Hisamitsu Investigator Site

Tucson, Arizona, United States

Site Status

Hisamitsu Investigator Site

Hot Springs, Arkansas, United States

Site Status

Hisamitsu Investigator Site

Anaheim, California, United States

Site Status

Hisamitsu Investigator Site

Anaheim, California, United States

Site Status

Hisamitsu Investigator Site

Buena Park, California, United States

Site Status

Hisamitsu Investigator Site

Long Beach, California, United States

Site Status

Hisamitsu Investigator Site

San Diego, California, United States

Site Status

Hisamitsu Investigator Site

San Luis Obispo, California, United States

Site Status

Hisamitsu Investigator Site

Daytona Beach, Florida, United States

Site Status

Hisamitsu Investigator Site

Hialeah, Florida, United States

Site Status

Hisamitsu Investigator Site

Jacksonville, Florida, United States

Site Status

Hisamitsu Investigator Site

Lauderdale Lakes, Florida, United States

Site Status

Hisamitsu Investigator Site

Oldsmar, Florida, United States

Site Status

Hisamitsu Investigator Site

Ormond Beach, Florida, United States

Site Status

Hisamitsu Investigator Site

South Miami, Florida, United States

Site Status

Hisamitsu Investigator Site

Evansville, Indiana, United States

Site Status

Hisamitsu Investigator Site

Omaha, Nebraska, United States

Site Status

Hisamitsu Investigator Site

Blackwood, New Jersey, United States

Site Status

Hisamitsu Investigator Site

South Bound Brook, New Jersey, United States

Site Status

Hisamitsu Investigator Site

Johnson City, Tennessee, United States

Site Status

Hisamitsu Investigator Site

Dallas, Texas, United States

Site Status

Hisamitsu Investigator Site

West Valley City, Utah, United States

Site Status

Hisamitsu Investigator Site

Danville, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HKT-500-US17

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Proof-of-concept Study of NSAID Hydrogel Patch in Treatment of Acute Pain
NCT02729207 TERMINATED PHASE2
An Efficacy and Safety Study for the Treatment of Mild to Moderate Acute Pain Associated With Ankle Strain or Sprain.
NCT02089425 TERMINATED PHASE3
A Multicenter Efficacy Study of a Diclofenac+Menthol Gel in Subjects With Ankle Sprain
NCT02100670 COMPLETED PHASE3
Approach to Ankle Sprains in the Emergency Department
NCT06563271 COMPLETED PHASE4
Phase III Trial to Evaluate the Efficacy and Safety in Patients With Ankle Sprains.
NCT06866613 COMPLETED PHASE3
MRX-7EAT Etodolac-Lidocaine Topical Patch in the Treatment of Ankle Sprains
NCT01198834 COMPLETED PHASE3
Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel in Patients With Acute Ankle Sprain
NCT00573768 COMPLETED PHASE2
Efficacy and Safety of SST 0225, a Topical Ibuprofen Cream, in the Treatment of Pain Associated With Acute Ankle Sprain
NCT01874626 COMPLETED PHASE3
Safety and Efficacy of Generic Diclofenac Epolamine Acute Pain Due to Minor Ankle Sprain
NCT02324270 COMPLETED PHASE3
Use of Platelet Rich Plasma Therapy for Acute Ankle Sprains in the Emergency Department
NCT01518335 COMPLETED NA
Ketorolac Applied by Continuous IV Infusion for Treatment of Moderately Severe Postoperative Pain Following Bunionectomy
NCT05324358 COMPLETED PHASE3
Efficacy and Safety of Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis
NCT00426985 TERMINATED PHASE3
A Pilot Study on the Onset of Action of KTP, 20% in the Treatment of Acute Pain Associated With Tendonitis or Bursitis of the Shoulder, Elbow or Knee
NCT00903994 COMPLETED PHASE2
Ketoprofen Topical Patch 20% in the Treatment of Pain Associated With Shoulder, Elbow or Knee Tendonitis or Bursitis
NCT00352625 COMPLETED PHASE3
Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
NCT03295721 COMPLETED PHASE3
The Effect of Injection Site Cooling on Pain Experienced After the Administration of CNTX-4975-05 Into the Knee
NCT03472677 COMPLETED PHASE1
Efficacy and Safety of Etoricoxib in Acute Ankle Sprain: A Double-Blind Comparative Study Among 2 Treatments Protocols
NCT00525993 UNKNOWN PHASE4
Evaluate the Efficacy and Safety of Diclofenac Diethylamine 2.32% Gel Applied Twice or Three Times Daily in Patients With Acute Ankle Sprain
NCT00955513 COMPLETED PHASE3
Topical Ketoprofen Versus Placebo in Patients With Ankle Sprain
NCT02393846 COMPLETED PHASE4
A Phase 2, Two-Part Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
NCT02471898 COMPLETED PHASE2
Translating Metabolic Responses to Mechanical Insult Into Early Interventions to Prevent PTOA
NCT04589611 COMPLETED PHASE1/PHASE2
Investigation of Corticosteroid Versus Placebo Injection in Patients With Syndesmotic Ligament Injury or High Ankle Sprain
NCT02892500 TERMINATED PHASE2
A Study of TLC590 for Postsurgical Pain Following Bunionectomy
NCT07222748 RECRUITING PHASE3
A Study to Evaluate the Efficacy and Safety of K-285 Compared With Menthol Gel for the Treatment of Delayed Onset Muscle Soreness (DOMS) in the Lower Extremity
NCT04484428 TERMINATED PHASE2
Diclofenac Patch for Treatment of Acute Pain Due to Mild to Moderate Ankle Sprain
NCT00869180 COMPLETED PHASE3