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HKT-500 in Adult Patients With Shoulder Pain (Pain)

Primary Purpose

Pain

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
HKT-500 Ketoprofen Topical Patch
Placebo Patch
Sponsored by
Hisamitsu Pharmaceutical Co., Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain focused on measuring Shoulder pain, Pain, Ketoprofen, Topical Patch

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Pharmaceutical Co., Inc.
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • HIsamitsu Pharmaceutical Co., Inc.
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • HIsamitsu Pharmaceutical Co., Inc.
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site
  • Hisamitsu Investigator Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

A,1 HKT-500 Ketoprofen Topical Patch

A,2 Placebo Patch

Arm Description

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

Treatment with placebo patch

Outcomes

Primary Outcome Measures

Pain Assessment

Secondary Outcome Measures

Safety Assessment

Full Information

First Posted
May 16, 2008
Last Updated
May 12, 2015
Sponsor
Hisamitsu Pharmaceutical Co., Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00680472
Brief Title
HKT-500 in Adult Patients With Shoulder Pain
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
April 2008 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hisamitsu Pharmaceutical Co., Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain
Keywords
Shoulder pain, Pain, Ketoprofen, Topical Patch

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
368 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A,1 HKT-500 Ketoprofen Topical Patch
Arm Type
Active Comparator
Arm Description
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
Arm Title
A,2 Placebo Patch
Arm Type
Placebo Comparator
Arm Description
Treatment with placebo patch
Intervention Type
Drug
Intervention Name(s)
HKT-500 Ketoprofen Topical Patch
Other Intervention Name(s)
Ketoprofen Topical Patch
Intervention Description
HKT-500 Ketoprofen Topical Patch
Intervention Type
Other
Intervention Name(s)
Placebo Patch
Other Intervention Name(s)
Sham treatment
Intervention Description
Treatment with Placebo Patch
Primary Outcome Measure Information:
Title
Pain Assessment
Time Frame
2 Weeks
Secondary Outcome Measure Information:
Title
Safety Assessment
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenichi Furuta
Organizational Affiliation
Hisamitsu Pharmaceutical Co., Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Hisamitsu Investigator Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Denver
State/Province
Colorado
ZIP/Postal Code
80204
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20003
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Chiefland
State/Province
Florida
ZIP/Postal Code
32626
Country
United States
Facility Name
Hisamitsu Investigator Site
City
DeLand
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33484
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Dunedin
State/Province
Florida
ZIP/Postal Code
34698
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Longwood
State/Province
Florida
ZIP/Postal Code
32779
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Oldsmar
State/Province
Florida
ZIP/Postal Code
34677
Country
United States
Facility Name
Hisamitsu Pharmaceutical Co., Inc.
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33603
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Blue Ridge
State/Province
Georgia
ZIP/Postal Code
30513
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Boise
State/Province
Idaho
ZIP/Postal Code
83702
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Paducah
State/Province
Kentucky
ZIP/Postal Code
42003
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Bowie
State/Province
Maryland
ZIP/Postal Code
20716
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49009
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27513
Country
United States
Facility Name
HIsamitsu Pharmaceutical Co., Inc.
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27615
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58108
Country
United States
Facility Name
HIsamitsu Pharmaceutical Co., Inc.
City
Perrysburg
State/Province
Ohio
ZIP/Postal Code
43551
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Hisamitsu Investigator Site
City
New Tazewell
State/Province
Tennessee
ZIP/Postal Code
37825
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Bryan
State/Province
Texas
ZIP/Postal Code
77802
Country
United States
Facility Name
Hisamitsu Investigator Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Hisamitsu Investigator Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States

12. IPD Sharing Statement

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HKT-500 in Adult Patients With Shoulder Pain

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