OsteoarthritisNCT02784691
Efficiency and Usability of the Iontophoretic Patch Feeligreen Diclofenac in Treating Acute Osteoarthritic Knee Pain
A study testing Feeligreen patch in people with Osteoarthritis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Feeligreen patch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2016to Jul 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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,
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
- Conditions
- Osteoarthritis
- Being tested
- Feeligreen patch
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feeligreen patchDevice
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Not described Receives: Device: Feeligreen patch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity reduction of pain
Measured by Visual Analog Scale
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study startOct 2016
- Primary completionJul 2017 (estimated)
- Study completionJul 2017 (estimated)
Why it stopped: Because of logistical problems
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02784691
- Sponsor's protocol ID
- 15-PP-15
- Status last verified
- Feb 2024
- First submitted
- 20 May 2016
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency and Usability of the Iontophoretic Patch Feeligreen Diclofenac in Treating Acute Osteoarthritic Knee Pain
- ClinicalTrials.gov ID
- NCT02784691
- Acronym / sponsor ID
- 15-PP-15
- Conditions
- Osteoarthritis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Because of logistical problems
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 27 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: Feeligreen patch |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 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,
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feeligreen patch | Device | Patients |
Primary outcome
Intensity reduction of pain
Time frame: 2 days
Measured by Visual Analog Scale
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feeligreen patch in people with Osteoarthritis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity reduction of pain (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.