NCT03063359 (FINDOL) is a Phase 3 clinical trial of Intranasal fentanyl + Oral Placebo in Pain, Acute, sponsored by University Hospital, Montpellier.

Who is sponsoring NCT03063359?

NCT03063359 is sponsored by University Hospital, Montpellier.

What drugs are being tested in NCT03063359?

Interventions in NCT03063359: Intranasal fentanyl + Oral Placebo, Oral Morphine + Intranasal Placebo.

What condition does NCT03063359 study?

NCT03063359 studies Pain, Acute.

Is NCT03063359 still recruiting?

NCT03063359 is currently terminated. Last updated 31 December 2020.

Last reviewed 2020-12-31 · How we verify

NCT03063359: FINDOL

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

Intranasal Fentanyl Versus Oral Morphine Sulfate in the Treatment of Pain in Pediatric Trauma

Terminated Phase 3 Last updated 31 December 2020

What this trial tests

Phase 3 trial testing Intranasal fentanyl + Oral Placebo in Pain, Acute in 22 participants. Terminated before completion.

Timeline

30 May 2017

Primary endpoint
18 July 2018

12 March 2019

Quick facts

Lead sponsor	University Hospital, Montpellier
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	22
Start date	30 May 2017
Primary completion	18 July 2018
Estimated completion	12 March 2019
Sites	1 location across France

Drugs / interventions tested

Intranasal fentanyl + Oral Placebo — full drug profile →
Oral Morphine + Intranasal Placebo — full drug profile →

Conditions studied

Pain, Acute — all drugs for Pain, Acute →

Sponsor

University Hospital, Montpellier

Who can join

Adults 4 to 15, any sex, with Pain, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Acute tramatic pain is one of main reasons for consultation in pediatric emergency departments. To manage pain quickly and effectively must be a primary outcome of the emergency department. However, pediatric emergency department are sometimes criticized for inadequate and delayed initiation analgesia . Indeed, several studies have shown the inadequacy between the intensity of the pain evaluated by the care team and the therapeutic management of it. The ideal analgesic must have a rapid onset of action, have a powerful analgesic effect, have few side effects and can be administered quickly and painlessly. That's why, the main outcome of this study is to assess the non inferiority of a treatment by intranasal Fentanyl vs morphine sulfate (oral use) in children with traumatic pain on arrival to pediatric emergency department.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other recruiting trials for Pain, Acute

Currently open trials in the same condition.

NCT07249827 — A Randomized Comparison Between 0.67 mcg/kg, 1 mcg/kg, and 1.33 mcg/kg of Perineural Dexmedetomidine for Ultrasound-Guid · Phase 2 · recruiting
NCT07053774 — Intranasal and Intravenous Oxytocin for Analgesia to Noxious Heat Pain · Phase 2 · recruiting
NCT07009951 — Impact of Virtual Reality in Cardiac Electrophysiology · recruiting
NCT06960317 — Empathy Through Pain Control: Lidocaine Paracervical Block for IUD Placements · NA · recruiting
NCT06754657 — CORA-Q15: Continuous vs. Single-injection Interscalene Block on QoR-15 in Outpatient Rotator Cuff Surgery · Phase 4 · recruiting

Other University Hospital, Montpellier trials

Trials by the same sponsor.

NCT07524127 — Phenotyping of Type 2 Inflammation Profile by Rheology of Nasal Secretions and Tissue Quantification of Eosinophilic Pol · NA · not yet recruiting
NCT07255495 — Effects of Neuromuscular Scoliosis Surgery on Nutritional Metabolism · NA · not yet recruiting
NCT07534189 — Prospective Cohort Study Evaluating a Thermal Spa Programme in Symptomatic Knee Osteoarthritis · NA · not yet recruiting
NCT07515638 — Immun4Cure Cohort of Autoimmune Diseases · not yet recruiting
NCT07406516 — Identification of Kinematic Variables Specific of Patellar Tendinopathy in Athletes at Risk · NA · not yet recruiting

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 NCT03063359 (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 University Hospital, Montpellier
Last refreshed: 31 December 2020

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/NCT03063359.

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