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Completed

NCT Number: NCT00647231

HKT-500-US12 In Adult Patients With OA Knee Pain

The objective of this study is to characterize the analgesic properties of single dose study of HKT-500 in subjects with pain caused by mild to moderate OA of the knee

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hisamitsu Investigator Site, Birmingham, Alabama, United States

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About this study

A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects with Pain Caused by Mild to Moderate Osteoarthritis of the Knee

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • male or female 45 years of age or older
  • with osteoarthritis of the knee

Exclusion criteria

  • subject is a woman of childbearing potential
  • who has a positive urine pregnancy test,
  • is lactating, or who is not surgically sterile

Treatment and study plan

HKT-500 Topical Patch

Drug

Treatment with Ketoprofen Topical Patch

Other names: HKT-500, Ketoprofen

Placebo patch

Other

Treatment with placebo patch

Other names: Sham tratment

Primary outcomes

  1. Time to Onset and Duration

    Time frame: 36 hours

Secondary outcomes

  1. Outcome Time Frame

    Time frame: 36 hours

Sponsors and collaborators

Lead sponsor

Hisamitsu Pharmaceutical Co., Inc.

Industry

Registry information

Official study title

Protocol HKT-500-US12: A Randomized, Multicenter, Double-Blind, Single Dose Study of the Analgesic Properties of HKT-500 and Placebo in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Mar 31, 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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