Clinical trial NCT00792727: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Osteoarthritis of the Knee
Keywords: Pain
Knee
Arthritis
Knee pain
Lead sponsor: Hisamitsu Pharmaceutical Co., Inc.
Sponsor class: INDUSTRY
First posted: 2008-11-18
Enrollment: 380
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change from the baseline of the WOMAC pain subscale score at Visit 6 (Day 14 ± 2 days)
timeFrame: 14 days ± 2 days
Secondary outcomes:
measure: 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)
timeFrame: 28 days (±3 days)
measure: WOMAC: Change from the baseline of the subscale scores for stiffness and physical function at Visit 5, Visit 6, Visit 7 and Visit 8
timeFrame: 28 days (±3 days)
measure: WOMAC: Change from the baseline of the composite score at Visit 5, Visit 6, Visit 7 and Visit 8
timeFrame: 28 days (±3 days)
measure: 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.
timeFrame: 28 days
measure: Subject's Global Assessment at Visit 6 and Visit 8
timeFrame: 28 days (±3 days)
measure: Investigator's Global Assessment at Visit 6 and Visit 8
timeFrame: 28 days (±3 days)
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Hisamitsu Investigator Site
state: Alabama
city: Chandler
country: United States
facility: Hisamitsu Investigator Site
state: Arizona
city: Peoria
country: United States
facility: Hisamitsu Investigator Site
state: Arizona
city: San Diego
country: United States
facility: Hisamitsu Investigator Site
state: California
city: Colorado Springs
country: United States
facility: Hisamitsu Investigator Site
state: Colorado
city: Denver
country: United States
facility: Hisamitsu Investigator Site
state: Colorado
city: Denver
country: United States
facility: Hisamitsu Investigator Site
state: Colorado
city: Daytona Beach
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Delray Beach
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Fort Myers
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Pembroke Pines
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Evansville
country: United States
facility: Hisamitsu Investigator Site
state: Indiana
city: Crestview Hills
country: United States
facility: Hisamitsu Investigator Site
state: Kentucky
city: Fall River
country: United States
facility: Hisamitsu Investigator Site
state: Massachusetts
city: Omaha
country: United States
facility: Hisamitsu Investigator Site
state: Nebraska
city: Las Vegas
country: United States
facility: Hisamitsu Investigator Site
state: Nevada
city: Reno
country: United States
facility: Hisamitsu Investigator Site
state: Nevada
city: Albuquerque
country: United States
facility: Hisamitsu Investigator Site
state: New Mexico
city: Greensboro
country: United States
facility: Hisamitsu Investigator Site
state: North Carolina
city: Bismark
country: United States
facility: Hisamitsu Investigator Site
state: North Dakota
city: Cincinnati
country: United States
facility: Hisamitsu Investigator Site
state: Ohio
city: Columbus
country: United States
facility: Hisamitsu Investigator Site
state: Ohio
city: Mogadore
country: United States
facility: Hisamitsu Investigator Site
state: Ohio
city: Zanesville
country: United States
facility: Hisamitsu Investigator Site
state: Ohio
city: Oklahoma City
country: United States
facility: Hisamitsu Investigator Site
state: Oklahoma
city: Tulsa
country: United States
facility: Hisamitsu Investigator Site
state: Oklahoma
city: Warwick
country: United States
facility: Hisamitsu Investigator Site
state: Rhode Island
city: Anderson
country: United States
facility: Hisamitsu Investigator Site
state: South Carolina
city: Austin
country: United States
facility: Hisamitsu Investigator Site
state: Texas
city: San Antonio
country: United States
facility: Hisamitsu Investigator Site
state: Texas
city: San Antonio
country: United States
facility: Hisamitsu Investigator Site
state: Texas
city: Salt Lake City
country: United States
facility: Hisamitsu Investigator Site
state: Utah
city: Arlington
country: United States
facility: Hisamitsu Investigator Site
state: Virginia
city: Charlottesville
country: United States
facility: Hisamitsu Investigator Site
state: Virginia
city: Newport News
country: United States
facility: Hisamitsu Investigator Site
state: Virginia
city: Yakima
country: United States
facility: Hisamitsu Investigator Site
state: Washington
Study officials:
affiliation: Hisamitsu Pharmaceutical Co., Inc.
name: Mr. Kenichi Furuta
role: STUDY_DIRECTOR
References: