Status:
COMPLETED
HKT-500 in Adult Patients With Shoulder Pain
Lead Sponsor:
Hisamitsu Pharmaceutical Co., Inc.
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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
- The subject has unilateral acute shoulder pain.
Exclusion
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2008
Estimated Enrollment :
368 Patients enrolled
Trial Details
Trial ID
NCT00680472
Start Date
April 1 2008
End Date
October 1 2008
Last Update
June 4 2015
Active Locations (35)
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1
Hisamitsu Investigator Site
Birmingham, Alabama, United States, 35209
2
Hisamitsu Investigator Site
Tempe, Arizona, United States, 85283
3
Hisamitsu Investigator Site
Fullerton, California, United States, 92835
4
Hisamitsu Investigator Site
Denver, Colorado, United States, 80204