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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Page 1 of 9 (35 locations)

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