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HKT-500 in Adult Patients With Shoulder Pain

This study has been completed.
Sponsor:
Information provided by:
Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier:
NCT00680472
First received: May 16, 2008
Last updated: October 28, 2008
Last verified: October 2008
History of Changes

May 16, 2008
October 28, 2008
April 2008
October 2008   (final data collection date for primary outcome measure)
Pain Assessment [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00680472 on ClinicalTrials.gov Archive Site
Safety Assessment [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
HKT-500 in Adult Patients With Shoulder Pain
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

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

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Pain
  • Drug: HKT-500 & Ketoprofen Topical Patch
    HKT-500 Topical Patch
    Other Names:
    • Ketoprofen Topical Patch
    • HKT-500
    • Ketoprofen
  • Drug: placebo
    placebo
    Other Name: HKT-500 Topical Patch
  • Placebo Comparator: A,1,
    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
    Intervention: Drug: placebo
  • Experimental: A,2
    Intervention: Drug: HKT-500 & Ketoprofen Topical Patch
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
368
October 2008
October 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00680472
HKT-500-US08
Yes
Mr. Kenichi Furuta, General Manager, International Development Dept., Hisamitsu Pharmaceutical Co., Inc
Hisamitsu Pharmaceutical Co., Inc.
Not Provided
Study Director: Kenichi Furuta Hisamitsu Pharmaceutical Co., Inc.
Hisamitsu Pharmaceutical Co., Inc.
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP