Efficacy and Safety of Impracor (Ketoprofen 10% Cream) Compared With Placebo in the Treatment of Acute Pain (Flare) Associated With Osteoarthritis of the Knee

Study Overview
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Brief Summary
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The primary objective of the study is to assess analgesic efficacy of Impracor (Ketoprofen 10% Cream) compared to placebo for acute pain associated with OA flare of the knee.

Official Title
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A Randomized, Multicenter, Double-Blind, Parallel-Group Study to Assess the Efficacy and Safety of Impracor (Ketoprofen 10% Cream) Compared With Placebo in the Treatment of Acute Pain (Flare) Associated With Osteoarthritis of the Knee

Conditions
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Acute Pain (Flare) Associated With Osteoarthritis (OA) of the Knee

Intervention / Treatment
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* Drug: Ketoprofen 10% Cream
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of OA of the knee according to the ACR criteria. Kellgren-Lawrence grade 2-3 disease Be willing to stop taking all analgesics including NSAIDs and opioids for the duration of the study, with exception of study-specified rescue medication. Exclusion Criteria: Total knee replacement surgery tentatively scheduled within next 6 months. Palpable knee effusion. Significant pain outside the target knee, including significant hip, back, or contralateral knee pain. Any type of orthopedic and/or prosthetic device or any skin abnormalities on the target knee that would prevent evaluations of local tolerability. History of asthma, rheumatoid arthritis, chronic inflammatory disease (e.g., colitis), or fibromyalgia. History of gastrointestinal bleeding or peptic ulcer disease within the past 3 years. Have a positive urine drug test for illegal drug substances, non-prescribed controlled substances, or alcohol at screening. Acute or chronic illness that in the opinion of the investigator could compromise the integrity of study data or place the subject at risk by participating in the study.

Ages Eligible for Study
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Minimum Age: 35 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Impracor (Ketoprofen 10% Cream)<br>Topical Cream over a period of 14 days | Drug: Ketoprofen 10% Cream<br> <br> * Other names: IPI-110;|
| Placebo Comparator: Placebo Cream:<br>Topical Cream over a period of 14 days | Drug: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary endpoint will be measured by changes in WOMAC pain subscale scores calculated by comparing baseline WOMAC pain subscale scores on Day 1 to the average WOMAC Pain Subscale scores on Day 4, 6, and 8. |  | Day 4, 6 and 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient Global Assessment of knee arthritis using the modified Patient Overall Health Assessment from Day 1 to Day 8. |  | Day 8 |