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

Primary Purpose

Osteoarthritis of the Knee

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ketoprofen Patch
Placebo Patch
Sponsored by
Hisamitsu Pharmaceutical Co., Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis of the Knee focused on measuring Pain, Knee, Arthritis, Knee pain

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ketoprofen Patch

Placebo Patch

Arm Description

Treatment with experimental drug

Treatment with placebo drug

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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)
WOMAC: Change from the baseline of the subscale scores for stiffness and physical function at Visit 5, Visit 6, Visit 7 and Visit 8
WOMAC: Change from the baseline of the composite score at Visit 5, Visit 6, Visit 7 and Visit 8
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.
Subject's Global Assessment at Visit 6 and Visit 8
Investigator's Global Assessment at Visit 6 and Visit 8

Full Information

First Posted
November 14, 2008
Last Updated
May 12, 2015
Sponsor
Hisamitsu Pharmaceutical Co., Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00792727
Brief Title
HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hisamitsu Pharmaceutical Co., Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis of the Knee
Keywords
Pain, Knee, Arthritis, Knee pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
380 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ketoprofen Patch
Arm Type
Experimental
Arm Description
Treatment with experimental drug
Arm Title
Placebo Patch
Arm Type
Placebo Comparator
Arm Description
Treatment with placebo drug
Intervention Type
Drug
Intervention Name(s)
ketoprofen Patch
Other Intervention Name(s)
Ketoprofen topical patch
Intervention Description
2 topical patches applied once daily for 28 days
Intervention Type
Other
Intervention Name(s)
Placebo Patch
Other Intervention Name(s)
Sham Treatment
Intervention Description
2 topical placebo patches applied once daily for 28 days
Primary Outcome Measure Information:
Title
Change from the baseline of the WOMAC pain subscale score at Visit 6 (Day 14 ± 2 days)
Time Frame
14 days ± 2 days
Secondary Outcome Measure Information:
Title
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)
Time Frame
28 days (±3 days)
Title
WOMAC: Change from the baseline of the subscale scores for stiffness and physical function at Visit 5, Visit 6, Visit 7 and Visit 8
Time Frame
28 days (±3 days)
Title
WOMAC: Change from the baseline of the composite score at Visit 5, Visit 6, Visit 7 and Visit 8
Time Frame
28 days (±3 days)
Title
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.
Time Frame
28 days
Title
Subject's Global Assessment at Visit 6 and Visit 8
Time Frame
28 days (±3 days)
Title
Investigator's Global Assessment at Visit 6 and Visit 8
Time Frame
28 days (±3 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mr. Kenichi Furuta
Organizational Affiliation
Hisamitsu Pharmaceutical Co., Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Hisamitsu Investigator Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35242
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Hisamitsu Investigator Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80910
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80209
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Crestview Hills
State/Province
Kentucky
ZIP/Postal Code
41017
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Fall River
State/Province
Massachusetts
ZIP/Postal Code
02720
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Bismark
State/Province
North Dakota
ZIP/Postal Code
58503
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45227
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43212
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Mogadore
State/Province
Ohio
ZIP/Postal Code
44260
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73109
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78752
Country
United States
Facility Name
Hisamitsu Investigator Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Hisamitsu Investigator Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78232
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Arlington
State/Province
Virginia
ZIP/Postal Code
22205
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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