HKT-500 in Adult Patients With Shoulder Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier:
NCT00680472
First received: May 16, 2008
Last updated: May 12, 2015
Last verified: May 2015
  Purpose

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


Condition Intervention Phase
Pain
Drug: HKT-500 Ketoprofen Topical Patch
Other: Placebo Patch
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Hisamitsu Pharmaceutical Co., Inc.:

Primary Outcome Measures:
  • Pain Assessment [ Time Frame: 2 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety Assessment [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 368
Study Start Date: April 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680472

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

No publications provided

Responsible Party: Hisamitsu Pharmaceutical Co., Inc.
ClinicalTrials.gov Identifier: NCT00680472     History of Changes
Other Study ID Numbers: HKT-500-US08
Study First Received: May 16, 2008
Last Updated: May 12, 2015
Health Authority: United States: Food and Drug Administration

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
Signs and Symptoms
Ketoprofen
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 01, 2015