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

Phase 3

Withdrawn

• Conditions: Acute Pain (Flare) Associated With Osteoarthritis (OA) of the Knee
• Interventions: Drug: Ketoprofen 10% Cream; Drug: Placebo

• Registration Number: NCT01890902
• Lead Sponsor: Imprimis Pharmaceuticals, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-06-27
• Study First Submitted QC: 2013-07-01
• Study First Posted: 2013-07-02
• Study Start: 2013-08
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-08
• Last Update Posted: 2013-11-13
• Primary Completion: 2014-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Impracor (Ketoprofen 10% Cream)	Ketoprofen 10% Cream	Topical Cream over a period of 14 days
Placebo Cream:	Placebo	Topical Cream over a period of 14 days

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Change in Patient Global Assessment of knee arthritis using the modified Patient Overall Health Assessment from Day 1 to Day 8.	Day 8