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NCT02784691 Clinical Trial

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

Osteoarthritis Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT02784691
Other study ID # 15-PP-15
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date October 2016
Est. completion date July 2017

Study information
Verified date February 2024
Source Centre Hospitalier Universitaire de Nice
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 70 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Feeligreen patch

Locations
Country Name City State
France CHU de Nice Nice

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intensity reduction of pain Measured by Visual Analog Scale 2 days
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