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Completed

NCT Number: NCT00680472

HKT-500 in Adult Patients With Shoulder Pain

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

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Key information

Conditions

Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Shoulder Pain Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hisamitsu Investigator Site, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

HKT-500 Ketoprofen Topical Patch

Drug

HKT-500 Ketoprofen Topical Patch

Other names: Ketoprofen Topical Patch

Placebo patch

Other

Treatment with Placebo Patch

Other names: Sham treatment

Primary outcomes

  1. Pain Assessment

    Time frame: 2 Weeks

Secondary outcomes

  1. Safety Assessment

    Time frame: 2 weeks

Sponsors and collaborators

Lead sponsor

Hisamitsu Pharmaceutical Co., Inc.

Industry

Registry information

Official study 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

Acronym: Pain

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
May 20, 2008
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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