Efficiency and Usability of the Iontophoretic Patch Feeligreen Diclofenac in Treating Acute Osteoarthritic Knee Pain

February 5, 2024 updated by: Centre Hospitalier Universitaire de Nice
The aim of the study is to evaluate the antalgic efficacity of Feeligreen® patch on osteoarthritic knee pain acute. This patch work by diffusion controlled by iontophoresis allowing an improvement of transdermal diffusion of active (Diclofenac).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

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

  • France
      • Nice, France, 06000
        • CHU de Nice

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

70 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with age above 70 years,
  • Having a knee Arthritis (unilateral or bilateral) for at least 6 months,
  • Pain intensity ≥ 40 mm on a visual analog scale (VAS)
  • Lack of analgesic treatment or analgesic,

Exclusion Criteria:

  • Cognitive disorders : moderate to severe stage or not allowing an understanding of the VAS (as determined by the clinician)
  • A history of chronic inflammatory rheumatic disease,
  • Diagnosis of osteoarthritis of secondary origin,
  • Non-steroidal anti-inflammatory medication within 7 days prior to inclusion,
  • Diagnosis of severe hepatic and renal insufficiency, gastrointestinal bleeding, severe heart failure,
  • Allergy to diclofenac or similar activity substances such as other NSAIDs, aspirin, excipients,
  • Damaged skin

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients
Device: Feeligreen patch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity reduction of pain
Time Frame: 2 days
Measured by Visual Analog Scale
2 days

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Nice

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

October 1, 2016

Primary Completion (Estimated)

July 1, 2017

Study Completion (Estimated)

July 1, 2017

Study Registration Dates

First Submitted

May 20, 2016

First Submitted That Met QC Criteria

May 26, 2016

First Posted (Estimated)

May 27, 2016

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-PP-15

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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