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

Osteoarthritis of the Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00792727
• Other study ID #: HKT-500-US07
• Status: Completed
• Phase: Phase 3
• First received: November 14, 2008
• Last updated: May 12, 2015
• Start date: September 2007
• Est. completion date: May 2008

Study information

• Verified date: May 2015
• Source: Hisamitsu Pharmaceutical Co., Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 380
• Est. completion date: May 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis of the Knee
• Osteoarthritis, Knee

Intervention

Drug:
• ketoprofen Patch
2 topical patches applied once daily for 28 days

Other:
• Placebo Patch
2 topical placebo patches applied once daily for 28 days

Locations

Country	Name	City	State
United States	Hisamitsu Investigator Site	Albuquerque	New Mexico
United States	Hisamitsu Investigator Site	Anderson	South Carolina
United States	Hisamitsu Investigator Site	Arlington	Virginia
United States	Hisamitsu Investigator Site	Austin	Texas
United States	Hisamitsu Investigator Site	Birmingham	Alabama
United States	Hisamitsu Investigator Site	Bismark	North Dakota
United States	Hisamitsu Investigator Site	Chandler	Arizona
United States	Hisamitsu Investigator Site	Charlottesville	Virginia
United States	Hisamitsu Investigator Site	Cincinnati	Ohio
United States	Hisamitsu Investigator Site	Colorado Springs	Colorado
United States	Hisamitsu Investigator Site	Columbus	Ohio
United States	Hisamitsu Investigator Site	Crestview Hills	Kentucky
United States	Hisamitsu Investigator Site	Daytona Beach	Florida
United States	Hisamitsu Investigator Site	Delray Beach	Florida
United States	Hisamitsu Investigator Site	Denver	Colorado
United States	Hisamitsu Investigator Site	Denver	Colorado
United States	Hisamitsu Investigator Site	Evansville	Indiana
United States	Hisamitsu Investigator Site	Fall River	Massachusetts
United States	Hisamitsu Investigator Site	Fort Myers	Florida
United States	Hisamitsu Investigator Site	Greensboro	North Carolina
United States	Hisamitsu Investigator Site	Las Vegas	Nevada
United States	Hisamitsu Investigator Site	Mogadore	Ohio
United States	Hisamitsu Investigator Site	Newport News	Virginia
United States	Hisamitsu Investigator Site	Oklahoma City	Oklahoma
United States	Hisamitsu Investigator Site	Omaha	Nebraska
United States	Hisamitsu Investigator Site	Pembroke Pines	Florida
United States	Hisamitsu Investigator Site	Peoria	Arizona
United States	Hisamitsu Investigator Site	Reno	Nevada
United States	Hisamitsu Investigator Site	Salt Lake City	Utah
United States	Hisamitsu Investigator Site	San Antonio	Texas
United States	Hisamitsu Investigator Site	San Antonio	Texas
United States	Hisamitsu Investigator Site	San Diego	California
United States	Hisamitsu Investigator Site	Tulsa	Oklahoma
United States	Hisamitsu Investigator Site	Warwick	Rhode Island
United States	Hisamitsu Investigator Site	Yakima	Washington
United States	Hisamitsu Investigator Site	Zanesville	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Hisamitsu Pharmaceutical Co., Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from the baseline of the WOMAC pain subscale score at Visit 6 (Day 14 ± 2 days)		14 days ± 2 days	No
Secondary	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)	No
Secondary	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)	No
Secondary	WOMAC: Change from the baseline of the composite score at Visit 5, Visit 6, Visit 7 and Visit 8		28 days (±3 days)	No
Secondary	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	No
Secondary	Subject's Global Assessment at Visit 6 and Visit 8		28 days (±3 days)	No
Secondary	Investigator's Global Assessment at Visit 6 and Visit 8		28 days (±3 days)	No