NCT02784691

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).

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Oct 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

February 7, 2024

Status Verified

February 1, 2024

Enrollment Period

9 months

First QC Date

May 20, 2016

Last Update Submit

February 5, 2024

Conditions

Osteoarthritis

Outcome Measures

Primary Outcomes (1)

  • Intensity reduction of pain

    Measured by Visual Analog Scale

    2 days

Study Arms (1)

Patients

EXPERIMENTAL
Device: Feeligreen patch

Interventions

Feeligreen patchDEVICE
Patients

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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,
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nice

Nice, 06000, France

Location

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2016

First Posted

May 27, 2016

Study Start

October 1, 2016

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

February 7, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)