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NCT00680472 Clinical Trial

HKT-500 in Adult Patients With Shoulder Pain

Pain Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00680472
Other study ID # HKT-500-US08
Secondary ID
Status Completed
Phase Phase 3
First received May 16, 2008
Last updated May 12, 2015
Start date April 2008
Est. completion date October 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

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 368
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

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

Related Conditions & MeSH terms

Intervention

Drug:
• HKT-500 Ketoprofen Topical Patch
HKT-500 Ketoprofen Topical Patch
Other:
• Placebo Patch
Treatment with Placebo Patch

Locations
Country Name City State
United States Hisamitsu Investigator Site Birmingham Alabama
United States Hisamitsu Investigator Site Blue Ridge Georgia
United States Hisamitsu Investigator Site Boise Idaho
United States Hisamitsu Investigator Site Bowie Maryland
United States Hisamitsu Investigator Site Bradenton Florida
United States Hisamitsu Investigator Site Bridgewater New Jersey
United States Hisamitsu Investigator Site Bryan Texas
United States Hisamitsu Investigator Site Cary North Carolina
United States Hisamitsu Investigator Site Chiefland Florida
United States Hisamitsu Investigator Site DeLand Florida
United States Hisamitsu Investigator Site Delray Beach Florida
United States Hisamitsu Investigator Site Denver Colorado
United States Hisamitsu Investigator Site Dunedin Florida
United States HIsamitsu Pharmaceutical Co., Inc. Durham North Carolina
United States Hisamitsu Investigator Site Fargo North Dakota
United States Hisamitsu Investigator Site Fargo North Dakota
United States Hisamitsu Investigator Site Fullerton California
United States Hisamitsu Investigator Site Kalamazoo Michigan
United States Hisamitsu Investigator Site Longwood Florida
United States Hisamitsu Investigator Site New Tazewell Tennessee
United States Hisamitsu Investigator Site Newport News Virginia
United States Hisamitsu Investigator Site Oldsmar Florida
United States Hisamitsu Pharmaceutical Co., Inc. Orange City Florida
United States Hisamitsu Investigator Site Paducah Kentucky
United States HIsamitsu Pharmaceutical Co., Inc. Perrysburg Ohio
United States Hisamitsu Investigator Site Plantation Florida
United States Hisamitsu Investigator Site Raleigh North Carolina
United States Hisamitsu Investigator Site San Antonio Texas
United States Hisamitsu Investigator Site Tampa Florida
United States Hisamitsu Investigator Site Tampa Florida
United States Hisamitsu Investigator Site Tempe Arizona
United States Hisamitsu Investigator Site Toledo Ohio
United States Hisamitsu Investigator Site Washington District of Columbia
United States Hisamitsu Investigator Site Wichita Kansas
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 Pain Assessment 2 Weeks No
Secondary Safety Assessment 2 weeks Yes
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