Clinical trial NCT00647231: HKT-500-US12 In Adult Patients With OA Knee Pain
Official title: Protocol HKT-500-US12: A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteoarthritis, Knee
Keywords: Osteoarthritis,Knee,Ketoprofen,Pain,Patch,Analgesic
Lead sponsor: Hisamitsu Pharmaceutical Co., Inc.
Sponsor class: INDUSTRY
First posted: 2008-03-31
Enrollment: 300
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL

Brief summary: The objective of this study is to characterize the analgesic properties of single dose study of HKT-500 in subjects with pain caused by mild to moderate OA of the knee

Detailed description: A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects with Pain Caused by Mild to Moderate Osteoarthritis of the Knee

Eligibility criteria: Inclusion Criteria:

* male or female 45 years of age or older
* with osteoarthritis of the knee

Exclusion Criteria:

* subject is a woman of childbearing potential
* who has a positive urine pregnancy test,
* is lactating, or who is not surgically sterile

Primary outcomes:
measure: Time to Onset and Duration
timeFrame: 36 hours
Secondary outcomes:
measure: Outcome Time Frame
timeFrame: 36 hours
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Hisamitsu Investigator Site
state: Alabama
city: Phoenix
country: United States
facility: Hisamitsu Investigator Site
state: Arizona
city: Little Rock
country: United States
facility: Hisamitsu Investigator Site
state: Arkansas
city: Little Rock
country: United States
facility: Hisamitsu Investigator Site
state: Arkansas
city: Burbank
country: United States
facility: Hisamitsu Investigator Site
state: California
city: Escondido
country: United States
facility: Hisamitsu Investigator Site
state: California
city: Northridge
country: United States
facility: Hisamitsu Investigator Site
state: California
city: Colorado Springs
country: United States
facility: Hisamitsu Investigator Site
state: Colorado
city: Deland
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Hallandale Beach
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Ocala
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Ormond Beach
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Austell
country: United States
facility: Hisamitsu Investigator Site
state: Georgia
city: Savannah
country: United States
facility: Hisamitsu Investigator Site
state: Georgia
city: Stockbridge
country: United States
facility: Hisamitsu Investigator Site
state: Georgia
city: Chicago
country: United States
facility: Hisamitsu Investigator Site
state: Illinois
city: Madisonville
country: United States
facility: Hisamitsu Investigator Site
state: Kentucky
city: Baton Rouge
country: United States
facility: Hisamitsu Investigator Site
state: Louisiana
city: Lake Charles
country: United States
facility: Hisamitsu Investigator Site
state: Louisiana
city: Flint
country: United States
facility: Hisamitsu Investigator Site
state: Michigan
city: Omaha
country: United States
facility: Hisamitsu Investigator Site
state: Nebraska
city: Berlin
country: United States
facility: Hisamitsu Investigator Site
state: New Jersey
city: Raleigh
country: United States
facility: Hisamitsu Investigator Site
state: North Carolina
city: Cincinnati
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: Duncansville
country: United States
facility: Hisamitsu Investigator Site
state: Pennsylvania
city: Houston
country: United States
facility: Hisamitsu Investigator Site
state: Texas
city: Salt Lake City
country: United States
facility: Hisamitsu Investigator Site
state: Utah
Study officials:
affiliation: Hisamitsu
name: Kenichi Furuta
role: STUDY_DIRECTOR
References: