HKT-500 in Adult Patients With Osteoarthritis (OA) Knee Pain

Study Overview
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Brief Summary
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Ketoprofen in a topical patch formulation has been demonstrated to be effective for treating mild to moderate pain caused by various musculoskeletal disorders.

Detailed Description
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The objective of this study is to demonstrate the short-term multiple dose efficacy and safety of HKT-500 in subjects with pain caused by mild to moderate osteoarthritis of the knee. The goal of the study is to gather additional information about the analgesic efficacy and safety of repeated, 24-hour applications of 2 HKT-500 patches per knee for a total of 28 days in subjects with pain caused by mild to moderate osteoarthritis of the knee.

Official Title
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A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Four-Week Study to Assess the Efficacy and Safety of HKT-500 in Subjects With Pain Caused by Mild to Moderate Osteoarthritis of the Knee

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: ketoprofen Patch
* Other: Placebo Patch


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: man or woman ≥45 years of age. clinical diagnosis of unilateral or bilateral OA of the knee taking an NSAID or acetaminophen on a regular basis and has a history of knee pain amelioration with NSAID or acetaminophen use. mild to moderate OA of the knee at the screening visit subject exhibits an arthritis flare in the target knee within 7 days day of withdrawing from a NSAID or acetaminophen. subject understands that treatment will be administered on an inpatient basis. subject is capable of understanding and complying with the protocol and has signed the informed consent document. Exclusion Criteria: subject is a woman of childbearing potential who has a positive urine pregnancy test, is lactating, or who is not surgically sterile subject has symptoms that are attributable to primary inflammatory diseases of the joint subject has unstable knees including a history of the knee catching or giving way or physical examination evidence of instability subject has arthropathies that occur in conjunction with systemic diseases subject has a chronic pain condition subject is grossly obese subject has a history of knee surgery within the past 12 months or arthroscopy within the past 6 months. subject has a history of osteotomies. subject is not willing to discontinue the use of NSAIDs, acetaminophen or other prohibited treatments subject used opioids for OA pain within 1 month

Ages Eligible for Study
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Minimum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ketoprofen Patch<br>Treatment with experimental drug | Drug: ketoprofen Patch<br>* 2 topical patches applied once daily for 28 days<br>* Other names: Ketoprofen topical patch;|
| Placebo Comparator: Placebo Patch<br>Treatment with placebo drug | Other: Placebo Patch<br>* 2 topical placebo patches applied once daily for 28 days<br>* Other names: Sham Treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from the baseline of the WOMAC pain subscale score at Visit 6 (Day 14 ± 2 days) |  | 14 days ± 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WOMAC: Change from the baseline of the pain subscale score at Visit 5 (Day 7 ±1 day), Visit 7 (Day 21 ±3 days) and Visit 8 (Day 28 ±3 days) |  | 28 days (±3 days) | 
| WOMAC: Change from the baseline of the subscale scores for stiffness and physical function at Visit 5, Visit 6, Visit 7 and Visit 8 |  | 28 days (±3 days) | 
| WOMAC: Change from the baseline of the composite score at Visit 5, Visit 6, Visit 7 and Visit 8 |  | 28 days (±3 days) | 
| Pain Intensity differences at rest, on motion and of overall assessment using a VAS scale at each follow-up assessments time point through Day 28. |  | 28 days | 
| Subject's Global Assessment at Visit 6 and Visit 8 |  | 28 days (±3 days) | 
| Investigator's Global Assessment at Visit 6 and Visit 8 |  | 28 days (±3 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pain, Knee, Arthritis, Knee pain