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

NCT ID: NCT02784691

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-31

Study Completion Date

2017-07-31

Brief Summary

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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).

Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients

Group Type EXPERIMENTAL

Feeligreen patch

Intervention Type DEVICE

Interventions

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Feeligreen patch

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de Nice

Nice, , France

Site Status

Countries

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France

Other Identifiers

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15-PP-15

Identifier Type: -

Identifier Source: org_study_id

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