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

Primary Purpose

Osteoarthritis

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Feeligreen patch
Sponsored by
Centre Hospitalier Universitaire de Nice
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis

Eligibility Criteria

70 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Nice

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients

Arm Description

Outcomes

Primary Outcome Measures

Intensity reduction of pain
Measured by Visual Analog Scale

Secondary Outcome Measures

Full Information

First Posted
May 20, 2016
Last Updated
July 29, 2016
Sponsor
Centre Hospitalier Universitaire de Nice
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1. Study Identification

Unique Protocol Identification Number
NCT02784691
Brief Title
Efficiency and Usability of the Iontophoretic Patch Feeligreen Diclofenac in Treating Acute Osteoarthritic Knee Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Feeligreen patch
Primary Outcome Measure Information:
Title
Intensity reduction of pain
Description
Measured by Visual Analog Scale
Time Frame
2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christine PINTARIC
Email
pintaric.c@chu-nice.fr
Facility Information:
Facility Name
CHU de Nice
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christine Pintaric
Email
pintaric.c@chu-nice.fr
First Name & Middle Initial & Last Name & Degree
Olivier GUERIN, Pr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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