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

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Four-Week Study to Assess the Efficacy and Safety of HKT-500 in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee

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

Study Overview

• Status: Completed
• Conditions: Osteoarthritis of the Knee
• Intervention / Treatment: Drug: ketoprofen Patch; Other: Placebo Patch

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 380
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
      • Hisamitsu Investigator Site
  • Arizona
    • Chandler, Arizona, United States, 85225
      • Hisamitsu Investigator Site
    • Peoria, Arizona, United States, 85381
      • Hisamitsu Investigator Site
  • California
    • San Diego, California, United States, 92108
      • Hisamitsu Investigator Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • Hisamitsu Investigator Site
    • Denver, Colorado, United States, 80204
      • Hisamitsu Investigator Site
    • Denver, Colorado, United States, 80209
      • Hisamitsu Investigator Site
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • Hisamitsu Investigator Site
    • Delray Beach, Florida, United States, 33484
      • Hisamitsu Investigator Site
    • Fort Myers, Florida, United States, 33916
      • Hisamitsu Investigator Site
    • Pembroke Pines, Florida, United States, 33024
      • Hisamitsu Investigator Site
  • Indiana
    • Evansville, Indiana, United States, 47714
      • Hisamitsu Investigator Site
  • Kentucky
    • Crestview Hills, Kentucky, United States, 41017
      • Hisamitsu Investigator Site
  • Massachusetts
    • Fall River, Massachusetts, United States, 02720
      • Hisamitsu Investigator Site
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Hisamitsu Investigator Site
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • Hisamitsu Investigator Site
    • Reno, Nevada, United States, 89502
      • Hisamitsu Investigator Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87102
      • Hisamitsu Investigator Site
  • North Carolina
    • Greensboro, North Carolina, United States, 27401
      • Hisamitsu Investigator Site
  • North Dakota
    • Bismark, North Dakota, United States, 58503
      • Hisamitsu Investigator Site
  • Ohio
    • Cincinnati, Ohio, United States, 45227
      • Hisamitsu Investigator Site
    • Columbus, Ohio, United States, 43212
      • Hisamitsu Investigator Site
    • Mogadore, Ohio, United States, 44260
      • Hisamitsu Investigator Site
    • Zanesville, Ohio, United States, 43701
      • Hisamitsu Investigator Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73109
      • Hisamitsu Investigator Site
    • Tulsa, Oklahoma, United States, 74136
      • Hisamitsu Investigator Site
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • Hisamitsu Investigator Site
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Hisamitsu Investigator Site
  • Texas
    • Austin, Texas, United States, 78752
      • Hisamitsu Investigator Site
    • San Antonio, Texas, United States, 78217
      • Hisamitsu Investigator Site
    • San Antonio, Texas, United States, 78232
      • Hisamitsu Investigator Site
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Hisamitsu Investigator Site
  • Virginia
    • Arlington, Virginia, United States, 22205
      • Hisamitsu Investigator Site
    • Charlottesville, Virginia, United States, 22911
      • Hisamitsu Investigator Site
    • Newport News, Virginia, United States, 23606
      • Hisamitsu Investigator Site
  • Washington
    • Yakima, Washington, United States, 98902
      • Hisamitsu Investigator Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ketoprofen Patch; Treatment with experimental drug	Drug: ketoprofen Patch; 2 topical patches applied once daily for 28 days; Other Names: Ketoprofen topical patch
Placebo Comparator: Placebo Patch; Treatment with placebo drug	Other: Placebo Patch; 2 topical placebo patches applied once daily for 28 days; Other Names: Sham Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from the baseline of the WOMAC pain subscale score at Visit 6 (Day 14 ± 2 days)	14 days ± 2 days

Secondary Outcome Measures

Outcome Measure	Time Frame
WOMAC: Change from the baseline of the pain subscale score at Visit 5 (Day 7 ±1 day), Visit 7 (Day 21 ±3 days) and Visit 8 (Day 28 ±3 days)	28 days (±3 days)
WOMAC: Change from the baseline of the subscale scores for stiffness and physical function at Visit 5, Visit 6, Visit 7 and Visit 8	28 days (±3 days)
WOMAC: Change from the baseline of the composite score at Visit 5, Visit 6, Visit 7 and Visit 8	28 days (±3 days)
Pain Intensity differences at rest, on motion and of overall assessment using a VAS scale at each follow-up assessments time point through Day 28.	28 days
Subject's Global Assessment at Visit 6 and Visit 8	28 days (±3 days)
Investigator's Global Assessment at Visit 6 and Visit 8	28 days (±3 days)

Collaborators and Investigators

• Sponsor: Hisamitsu Pharmaceutical Co., Inc.
• Investigators: Study Director: Mr. Kenichi Furuta, Hisamitsu Pharmaceutical Co., Inc.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): April 1, 2008
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: November 14, 2008
• First Submitted That Met QC Criteria: November 17, 2008
• First Posted (Estimate): November 18, 2008

Study Record Updates

• Last Update Posted (Estimate): June 4, 2015
• Last Update Submitted That Met QC Criteria: May 12, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Keywords: Arthritis; Pain; Knee; Knee pain
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis; Osteoarthritis, Knee; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Ketoprofen
• Other Study ID Numbers: HKT-500-US07