Who is sponsoring NCT04976088?

NCT04976088 is sponsored by Fidia Farmaceutici s.p.a..

What drugs are being tested in NCT04976088?

Interventions in NCT04976088: Diclofenac Sodium 140 mg medicated plaster, Diclofenac epolamine (DIEP) 180mg medicated plaster, Flector, Placebo.

What condition does NCT04976088 study?

NCT04976088 studies Trauma Injury, Inflammation.

Is NCT04976088 still recruiting?

NCT04976088 is currently completed. Last updated 2 October 2023.

Last reviewed 2023-10-02 · How we verify

NCT04976088

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Clinical Trial With Diclofenac Sodium Medicated Plaster in Patients With Impact Injuries of the Limbs

Completed Phase 3 Last updated 2 October 2023

What this trial tests

Phase 3 trial testing Diclofenac Sodium 140 mg medicated plaster in Trauma Injury in 214 participants. Completed in 27 October 2018.

Timeline

25 May 2018

Primary endpoint
27 October 2018

27 October 2018

Quick facts

Lead sponsor	Fidia Farmaceutici s.p.a.
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	214
Start date	25 May 2018
Primary completion	27 October 2018
Estimated completion	27 October 2018
Sites	16 locations across Hungary, Germany, Italy

Drugs / interventions tested

Diclofenac Sodium 140 mg medicated plaster — full drug profile →
Diclofenac epolamine (DIEP) 180mg medicated plaster, Flector — full drug profile →
Placebo

Conditions studied

Trauma Injury — all drugs for Trauma Injury →
Inflammation — all drugs for Inflammation →

Sponsor

Fidia Farmaceutici s.p.a. — full company profile →

Who can join

Adults 18 to 65, any sex, with Trauma Injury or Inflammation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Phase III, multinational, multicentre, randomized, prospective, double blind, parallel groups, placebo-controlled study to evaluate the analgesic effects of Test Diclofenac Sodium 140mg medicated plaster, Reference DIEP 180 mg medicated plaster, Flector® and Placebo plaster in patients with painful and phlogistic disease due to acute traumatic events of the limbs.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Trauma Injury

Currently open trials in the same condition.

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NCT06606119 — The Role of Brain-Bone Marrow-Gut Interaction Following Major Trauma · recruiting
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NCT07072286 — RELIEVED (REgionaL anesthesIa PElVic fracturEs stuDy) Study. Regional Anesthesia (RA) Techniques for Pain Management in · recruiting
NCT05721378 — Permissive Weight Bearing in Displaced Intra-articular Calcaneal Fractures · NA · recruiting

Other Fidia Farmaceutici s.p.a. trials

Trials by the same sponsor.

NCT06190028 — Evaluation of Performance and Safety of Carbopol 980 NF 0.2%- Based Medical Device in the Management of Patients With Gl · NA · terminated
NCT06108999 — Management of Acute and Chronic Wounds With Hyaluronic Acid · NA · recruiting
NCT06062771 — Efficacy and Safety of the Use of Ophthalmic Viscosurgical Devices (OVD) FIDIAL PLUS vs IAL®-F During Cataract Surgery · NA · completed
NCT06103812 — Evaluate Performance and Safety of Hyalo4 Skin in Acute and Chronic Wounds · unknown
NCT04757038 — An Open Label, Randomized-controlled Trial to Assess Efficacy Safety of HYALODISC With Physical Exercise Program · NA · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04976088 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Fidia Farmaceutici s.p.a.
Last refreshed: 2 October 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04976088.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing