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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00647231

Enrollment

300

Registered

2008-03-31

Start date

2008-03-31

Completion date

2008-08-31

Last updated

2015-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis, Knee

Keywords

Osteoarthritis,Knee,Ketoprofen,Pain,Patch,Analgesic

Brief summary

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

Detailed description

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

Interventions

DRUGHKT-500 Topical Patch

Treatment with Ketoprofen Topical Patch

OTHERPlacebo Patch

Treatment with placebo patch

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

45 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to Onset and Duration	36 hours

Secondary

Measure	Time frame
Outcome Time Frame	36 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026