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

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ClinicalTrials.gov Identifier: NCT00680472
Recruitment Status : Completed
First Posted : May 20, 2008
Last Update Posted : June 4, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The objective of this study is to determine the efficacy of HKT-500 in subjects with acute shoulder pain

Condition or disease Intervention/treatment Phase
Pain Drug: HKT-500 Ketoprofen Topical Patch Other: Placebo Patch Phase 3

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 368 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : April 2008
Primary Completion Date : October 2008
Study Completion Date : October 2008

Resource links provided by the National Library of Medicine

Drug Information available for: Ketoprofen
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: A,1 HKT-500 Ketoprofen Topical Patch
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
Drug: HKT-500 Ketoprofen Topical Patch
HKT-500 Ketoprofen Topical Patch
Other Name: Ketoprofen Topical Patch
Placebo Comparator: A,2 Placebo Patch
Treatment with placebo patch
Other: Placebo Patch
Treatment with Placebo Patch
Other Name: Sham treatment


Outcome Measures

Primary Outcome Measures :
  1. Pain Assessment [ Time Frame: 2 Weeks ]

Secondary Outcome Measures :
  1. Safety Assessment [ Time Frame: 2 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00680472


  Show 35 Study Locations
Sponsors and Collaborators
Hisamitsu Pharmaceutical Co., Inc.
Investigators
Study Director: Kenichi Furuta Hisamitsu Pharmaceutical Co., Inc.
More Information

Responsible Party: Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier: NCT00680472     History of Changes
Other Study ID Numbers: HKT-500-US08
First Posted: May 20, 2008    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: May 2015

Keywords provided by Hisamitsu Pharmaceutical Co., Inc.:
Shoulder pain
Pain
Ketoprofen
Topical Patch

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Ketoprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action