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HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain

NCT ID: NCT00792727

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

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

380 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2008-05-31

Brief Summary

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Ketoprofen in a topical patch formulation has been demonstrated to be effective for treating mild to moderate pain caused by various musculoskeletal disorders.

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Detailed Description

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The objective of this study is to demonstrate the short-term multiple dose efficacy and safety of HKT-500 in subjects with pain caused by mild to moderate osteoarthritis of the knee. The goal of the study is to gather additional information about the analgesic efficacy and safety of repeated, 24-hour applications of 2 HKT-500 patches per knee for a total of 28 days in subjects with pain caused by mild to moderate osteoarthritis of the knee.

Conditions

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Osteoarthritis of the Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Ketoprofen Patch

Treatment with experimental drug

Group Type EXPERIMENTAL

ketoprofen Patch

Intervention Type DRUG

2 topical patches applied once daily for 28 days

Placebo Patch

Treatment with placebo drug

Group Type PLACEBO_COMPARATOR

Placebo Patch

Intervention Type OTHER

2 topical placebo patches applied once daily for 28 days

Interventions

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ketoprofen Patch

2 topical patches applied once daily for 28 days

Intervention Type DRUG

Placebo Patch

2 topical placebo patches applied once daily for 28 days

Intervention Type OTHER

Other Intervention Names

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Ketoprofen topical patch Sham Treatment

Eligibility Criteria

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Inclusion Criteria

* man or woman ≥45 years of age.
* clinical diagnosis of unilateral or bilateral OA of the knee
* taking an NSAID or acetaminophen on a regular basis and has a history of knee pain amelioration with NSAID or acetaminophen use.
* mild to moderate OA of the knee at the screening visit
* subject exhibits an arthritis "flare" in the target knee within 7 days day of withdrawing from a NSAID or acetaminophen.
* subject understands that treatment will be administered on an inpatient basis.
* subject is capable of understanding and complying with the protocol and has signed the informed consent document.

Exclusion Criteria

* subject is a woman of childbearing potential who has a positive urine pregnancy test, is lactating, or who is not surgically sterile
* subject has symptoms that are attributable to primary inflammatory diseases of the joint
* subject has unstable knees including a history of the knee catching or giving way or physical examination evidence of instability
* subject has arthropathies that occur in conjunction with systemic diseases
* subject has a chronic pain condition
* subject is grossly obese
* subject has a history of knee surgery within the past 12 months or arthroscopy within the past 6 months.
* subject has a history of osteotomies.
* subject is not willing to discontinue the use of NSAIDs, acetaminophen or other prohibited treatments
* subject used opioids for OA pain within 1 month
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hisamitsu Pharmaceutical Co., Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mr. Kenichi Furuta

Role: STUDY_DIRECTOR

Hisamitsu Pharmaceutical Co., Inc.

Locations

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Hisamitsu Investigator Site

Birmingham, Alabama, United States

Site Status

Hisamitsu Investigator Site

Chandler, Arizona, United States

Site Status

Hisamitsu Investigator Site

Peoria, Arizona, United States

Site Status

Hisamitsu Investigator Site

San Diego, California, United States

Site Status

Hisamitsu Investigator Site

Colorado Springs, Colorado, United States

Site Status

Hisamitsu Investigator Site

Denver, Colorado, United States

Site Status

Hisamitsu Investigator Site

Denver, Colorado, United States

Site Status

Hisamitsu Investigator Site

Daytona Beach, Florida, United States

Site Status

Hisamitsu Investigator Site

Delray Beach, Florida, United States

Site Status

Hisamitsu Investigator Site

Fort Myers, Florida, United States

Site Status

Hisamitsu Investigator Site

Pembroke Pines, Florida, United States

Site Status

Hisamitsu Investigator Site

Evansville, Indiana, United States

Site Status

Hisamitsu Investigator Site

Crestview Hills, Kentucky, United States

Site Status

Hisamitsu Investigator Site

Fall River, Massachusetts, United States

Site Status

Hisamitsu Investigator Site

Omaha, Nebraska, United States

Site Status

Hisamitsu Investigator Site

Las Vegas, Nevada, United States

Site Status

Hisamitsu Investigator Site

Reno, Nevada, United States

Site Status

Hisamitsu Investigator Site

Albuquerque, New Mexico, United States

Site Status

Hisamitsu Investigator Site

Greensboro, North Carolina, United States

Site Status

Hisamitsu Investigator Site

Bismarck, North Dakota, United States

Site Status

Hisamitsu Investigator Site

Cincinnati, Ohio, United States

Site Status

Hisamitsu Investigator Site

Columbus, Ohio, United States

Site Status

Hisamitsu Investigator Site

Mogadore, Ohio, United States

Site Status

Hisamitsu Investigator Site

Zanesville, Ohio, United States

Site Status

Hisamitsu Investigator Site

Oklahoma City, Oklahoma, United States

Site Status

Hisamitsu Investigator Site

Tulsa, Oklahoma, United States

Site Status

Hisamitsu Investigator Site

Warwick, Rhode Island, United States

Site Status

Hisamitsu Investigator Site

Anderson, South Carolina, United States

Site Status

Hisamitsu Investigator Site

Austin, Texas, United States

Site Status

Hisamitsu Investigator Site

San Antonio, Texas, United States

Site Status

Hisamitsu Investigator Site

San Antonio, Texas, United States

Site Status

Hisamitsu Investigator Site

Salt Lake City, Utah, United States

Site Status

Hisamitsu Investigator Site

Arlington, Virginia, United States

Site Status

Hisamitsu Investigator Site

Charlottesville, Virginia, United States

Site Status

Hisamitsu Investigator Site

Newport News, Virginia, United States

Site Status

Hisamitsu Investigator Site

Yakima, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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HKT-500-US07

Identifier Type: -

Identifier Source: org_study_id

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