Ketoprofen Topical Patch, 20% in the Treatment of Pain Associated With Osteoarthritis Flare of the Knee

February 17, 2020 updated by: APR Applied Pharma Research s.a.

A Phase III Study of the Efficacy, Tolerability and Safety of the Ketoprofen Topical Patch, 20% (KTP) in the Treatment of Pain Associated With Osteoarthritis Flare of the Knee, Including a Randomized, Double-Blind, Placebo-Controlled, Parallel Group Phase Followed by an Open-Label Treatment Phase

The purpose of this study is to evaluate the effect of a ketoprofen topical patch on the pain associated with Osteoarthritis Flare of the Knee.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This randomized, double-blind placebo-controlled parallel group study will be conducted with patients who have experienced a flare of osteoarthritis of the knee. At screening, patients whose pain is currently controlled by an analgesic will agree, after giving Informed Consent, to discontinue that analgesic. Eligible patients will be randomized (1:1 ratio) to receive double-blind treatment with either the ketoprofen topical patch or a matching placebo patch to be applied once daily for 28 days. Patients will return to the clinic on Days 7, 14, 21 and 28. At Day 28, patients may choose to open a 2 month open-label period.

Patients will rate their pain using the Knee Injury and Osteoarthritis Outcome Score (KOOS) which contains the WOMAC pain subscale. Patients will also complete an electronic diary in which pain intensity, pain relief, and quality of sleep ratings will be captured. In addition, rescue medication consumption data will be collected. Ibuprofen will be provided as prn rescue medication.

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Males or females 18 years of age or older
  • Diagnosis of osteoarthritis of the knee (unilateral or bilateral)
  • Meet pain entry criteria
  • Willing to discontinue use of all analgesic medications (including over-the-counter [OTC] analgesics) except those provided as the study treatment and rescue medication specifically for study purposes.

Exclusion Criteria:

  • Positive urine pregnancy test, pregnant or lactating.
  • Have fibromyalgia, inflammatory arthritis, gout, pseudo-gout or Paget's disease
  • Have any other type of clinically significant joint disease or have had joint replacement surgery at the index knee
  • Have received either a corticosteroid injection in the 4 weeks preceding the screening visit or hyaluronic acid within 6 months of the screening visit
  • Have a history or physical examination finding that is incompatible with safe participation in the study or study product use
  • Are taking medications or other substances contraindicated due to the nature of the study medication or the potential for drug interactions.
  • Have significant renal or hepatic impairment
  • Are taking a sleep medication at a dose that has not been stable for at least 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Pain as measured by the pain subscale of the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index at Week 2

Secondary Outcome Measures

Outcome Measure
Functional disability
Use of prn rescue medication
Quality of sleep
Patient's and physician's global assessments of study medication
Pain intensity, pain relief (diary)
Lost days of work

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

APR Applied Pharma Research s.a.

Investigators

  • Principal Investigator: PPD, PPD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

May 1, 2007

Study Registration Dates

First Submitted

August 16, 2006

First Submitted That Met QC Criteria

August 16, 2006

First Posted (Estimate)

August 17, 2006

Study Record Updates

Last Update Posted (Actual)

February 19, 2020

Last Update Submitted That Met QC Criteria

February 17, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EN3269-303

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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