Clinical trial NCT00680472: HKT-500 in Adult Patients With Shoulder Pain
Official title: Protocol HKT-500-US08: A Randomized, Multicenter, Double-blind, Placebo-controlled, Two-week Study to Assess the Efficacy and Safety of HKT-500 in Subjects With Acute Shoulder Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Shoulder pain
Pain
Ketoprofen
Topical Patch
Lead sponsor: Hisamitsu Pharmaceutical Co., Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-20
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine the efficacy of HKT-500 in subjects with acute shoulder pain

Detailed description: Randomized, double-blind, placebo-controlled, multicenter study in men and women 18 years of age or greater who have acute shoulder pain requiring analgesic treatment daily for at least 2 weeks.

Eligibility criteria: Inclusion Criteria:

* The subject has unilateral acute shoulder pain.

Exclusion Criteria:

* The subject is a women of childbearing potential who has a positive urine pregnancy test, or who is lactating, or who is not surgically sterile (by tubal ligation or hysterectomy), or at least 2 years postmenopausal, and has not practiced an acceptable form of birth control (defined as the use of an intrauterine device with spermicide, a barrier method with spermicide, condoms with spermicide, subdermal implant, oral contraceptives, or abstinence) for at least 2 months prior to Visit 1.

Primary outcomes:
measure: Pain Assessment
timeFrame: 2 Weeks
Secondary outcomes:
measure: Safety Assessment
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Hisamitsu Investigator Site
state: Alabama
city: Tempe
country: United States
facility: Hisamitsu Investigator Site
state: Arizona
city: Fullerton
country: United States
facility: Hisamitsu Investigator Site
state: California
city: Denver
country: United States
facility: Hisamitsu Investigator Site
state: Colorado
city: Washington
country: United States
facility: Hisamitsu Investigator Site
state: District of Columbia
city: Bradenton
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Chiefland
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: DeLand
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Delray Beach
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Dunedin
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Longwood
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Oldsmar
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Orange City
country: United States
facility: Hisamitsu Pharmaceutical Co., Inc.
state: Florida
city: Plantation
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Tampa
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Tampa
country: United States
facility: Hisamitsu Investigator Site
state: Florida
city: Blue Ridge
country: United States
facility: Hisamitsu Investigator Site
state: Georgia
city: Boise
country: United States
facility: Hisamitsu Investigator Site
state: Idaho
city: Wichita
country: United States
facility: Hisamitsu Investigator Site
state: Kansas
city: Paducah
country: United States
facility: Hisamitsu Investigator Site
state: Kentucky
city: Bowie
country: United States
facility: Hisamitsu Investigator Site
state: Maryland
city: Kalamazoo
country: United States
facility: Hisamitsu Investigator Site
state: Michigan
city: Bridgewater
country: United States
facility: Hisamitsu Investigator Site
state: New Jersey
city: Cary
country: United States
facility: Hisamitsu Investigator Site
state: North Carolina
city: Durham
country: United States
facility: HIsamitsu Pharmaceutical Co., Inc.
state: North Carolina
city: Raleigh
country: United States
facility: Hisamitsu Investigator Site
state: North Carolina
city: Fargo
country: United States
facility: Hisamitsu Investigator Site
state: North Dakota
city: Fargo
country: United States
facility: Hisamitsu Investigator Site
state: North Dakota
city: Perrysburg
country: United States
facility: HIsamitsu Pharmaceutical Co., Inc.
state: Ohio
city: Toledo
country: United States
facility: Hisamitsu Investigator Site
state: Ohio
city: Zanesville
country: United States
facility: Hisamitsu Investigator Site
state: Ohio
city: New Tazewell
country: United States
facility: Hisamitsu Investigator Site
state: Tennessee
city: Bryan
country: United States
facility: Hisamitsu Investigator Site
state: Texas
city: San Antonio
country: United States
facility: Hisamitsu Investigator Site
state: Texas
city: Newport News
country: United States
facility: Hisamitsu Investigator Site
state: Virginia
Study officials:
affiliation: Hisamitsu Pharmaceutical Co., Inc.
name: Kenichi Furuta
role: STUDY_DIRECTOR
References: