HKT-500 in Adult Patients With Shoulder Pain
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
1 other identifier
interventional
368
1 country
35
Brief Summary
The objective of this study is to determine the efficacy of HKT-500 in subjects with acute shoulder pain
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 pain
Started Apr 2008
Shorter than P25 for phase_3 pain
35 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 16, 2008
CompletedFirst Posted
Study publicly available on registry
May 20, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedJune 4, 2015
May 1, 2015
6 months
May 16, 2008
May 12, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pain Assessment
2 Weeks
Secondary Outcomes (1)
Safety Assessment
2 weeks
Study Arms (2)
A,1 HKT-500 Ketoprofen Topical Patch
ACTIVE COMPARATORA Randomized, Multicenter, Double-Blind, Placebo-Controlled, Two-Week Study to Assess the Efficacy and Safety of HKT-500 in Subjects with Acute Shoulder Pain
A,2 Placebo Patch
PLACEBO COMPARATORTreatment with placebo patch
Interventions
HKT-500 Ketoprofen Topical Patch
Eligibility Criteria
You may qualify if:
- The subject has unilateral acute shoulder pain.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (35)
Hisamitsu Investigator Site
Birmingham, Alabama, 35209, United States
Hisamitsu Investigator Site
Tempe, Arizona, 85283, United States
Hisamitsu Investigator Site
Fullerton, California, 92835, United States
Hisamitsu Investigator Site
Denver, Colorado, 80204, United States
Hisamitsu Investigator Site
Washington D.C., District of Columbia, 20003, United States
Hisamitsu Investigator Site
Bradenton, Florida, 34209, United States
Hisamitsu Investigator Site
Chiefland, Florida, 32626, United States
Hisamitsu Investigator Site
DeLand, Florida, 32720, United States
Hisamitsu Investigator Site
Delray Beach, Florida, 33484, United States
Hisamitsu Investigator Site
Dunedin, Florida, 34698, United States
Hisamitsu Investigator Site
Longwood, Florida, 32779, United States
Hisamitsu Investigator Site
Oldsmar, Florida, 34677, United States
Hisamitsu Pharmaceutical Co., Inc.
Orange City, Florida, 32763, United States
Hisamitsu Investigator Site
Plantation, Florida, 33324, United States
Hisamitsu Investigator Site
Tampa, Florida, 33603, United States
Hisamitsu Investigator Site
Tampa, Florida, 33609, United States
Hisamitsu Investigator Site
Blue Ridge, Georgia, 30513, United States
Hisamitsu Investigator Site
Boise, Idaho, 83702, United States
Hisamitsu Investigator Site
Wichita, Kansas, 67205, United States
Hisamitsu Investigator Site
Paducah, Kentucky, 42003, United States
Hisamitsu Investigator Site
Bowie, Maryland, 20716, United States
Hisamitsu Investigator Site
Kalamazoo, Michigan, 49009, United States
Hisamitsu Investigator Site
Bridgewater, New Jersey, 08807, United States
Hisamitsu Investigator Site
Cary, North Carolina, 27513, United States
HIsamitsu Pharmaceutical Co., Inc.
Durham, North Carolina, 27704, United States
Hisamitsu Investigator Site
Raleigh, North Carolina, 27615, United States
Hisamitsu Investigator Site
Fargo, North Dakota, 58104, United States
Hisamitsu Investigator Site
Fargo, North Dakota, 58108, United States
HIsamitsu Pharmaceutical Co., Inc.
Perrysburg, Ohio, 43551, United States
Hisamitsu Investigator Site
Toledo, Ohio, 43623, United States
Hisamitsu Investigator Site
Zanesville, Ohio, 43701, United States
Hisamitsu Investigator Site
New Tazewell, Tennessee, 37825, United States
Hisamitsu Investigator Site
Bryan, Texas, 77802, United States
Hisamitsu Investigator Site
San Antonio, Texas, 78217, United States
Hisamitsu Investigator Site
Newport News, Virginia, 23606, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kenichi Furuta
Hisamitsu Pharmaceutical Co., Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2008
First Posted
May 20, 2008
Study Start
April 1, 2008
Primary Completion
October 1, 2008
Study Completion
October 1, 2008
Last Updated
June 4, 2015
Record last verified: 2015-05