NCT02056223 (PARIDA) is a Phase 2, PHASE3 clinical trial of Intravenous paracetamol in Ductus Arteriosus Patent, sponsored by University of Padova.

Who is sponsoring NCT02056223?

NCT02056223 is sponsored by University of Padova.

What drugs are being tested in NCT02056223?

Interventions in NCT02056223: Intravenous paracetamol, Intravenous ibuprofen.

What condition does NCT02056223 study?

NCT02056223 studies Ductus Arteriosus Patent, Respiratory Distress Syndrome.

Is NCT02056223 still recruiting?

NCT02056223 is currently suspended. Last updated 4 November 2019.

Last reviewed 2019-11-04 · How we verify

NCT02056223: PARIDA

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

Paracetamol vs Ibuprofen for PDA Closure in Preterm Infants.

Suspended Phase 2, PHASE3 Last updated 4 November 2019

What this trial tests

Phase 2, PHASE3 trial testing Intravenous paracetamol in Ductus Arteriosus Patent in 120 participants. Suspended.

Timeline

9 January 2017

Primary endpoint
31 October 2019

31 October 2019

Quick facts

Lead sponsor	University of Padova
Phase	Phase 2, PHASE3
Status	Suspended
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	120
Start date	9 January 2017
Primary completion	31 October 2019
Estimated completion	31 October 2019
Sites	1 location across Italy

Drugs / interventions tested

Intravenous paracetamol — full drug profile →
Intravenous ibuprofen — full drug profile →

Conditions studied

Ductus Arteriosus Patent — all drugs for Ductus Arteriosus Patent →
Respiratory Distress Syndrome — all drugs for Respiratory Distress Syndrome →

Sponsor

University of Padova

Who can join

Adults 36 Hours to 72 Hours, any sex, with Ductus Arteriosus Patent or Respiratory Distress Syndrome. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Current pharmacological options to treat an hemodynamically significant PDA (HsPDA) in preterm infants are limited to non-selective cyclo-oxygenase (COX) inhibitors, indomethacin or ibuprofen. Recently paracetamol exposure has been reported to successful closure of PDA. Aim of this randomized double-blind controlled study is to compare the efficacy and the safety of standard PDA treatment ibuprofen versus paracetamol-experimental treatment . We hypothesize that paracetamol is more effective than ibuprofen in closing PDA, perhaps ameliorating the safety profile of the pharmacological treatment.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low birth weight infants.
Ohlsson A, Shah PS. · · 2018 · cited 64× · PMID 29624206 · DOI 10.1002/14651858.cd010061.pub3
Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low birth weight infants.
Ohlsson A, Shah PS. · · 2020 · cited 59× · PMID 31985831 · DOI 10.1002/14651858.cd010061.pub4
Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low birth weight infants.
Jasani B, Mitra S, Shah PS. · · 2022 · cited 22× · PMID 36519620 · DOI 10.1002/14651858.cd010061.pub5
Ibuprofen enantiomers in premature neonates with patent ductus arteriosus: Preliminary data on an unexpected pharmacokinetic profile of S(+)-ibuprofen.
Padrini R, Ancora C, Nardo D, De Rosa G, et al · · 2021 · cited 4× · PMID 33779002 · DOI 10.1002/chir.23308

Verify or expand the search:

Other trials of Intravenous paracetamol

Trials testing the same drug.

NCT06731556 — Analgesic Effects of Intranasal Diclofenac Sodium, Ibuprofen, and Paracetamol in Pediatric Tonsillectomy Cases · Phase 3 · completed
NCT04691856 — Efficacy of Intravenous Paracetamol and Ibuprofen on Postoperative Pain and Morphine Consumption in Hysterectomy · NA · completed
NCT03437707 — Efficacy of Intravenous Ibuprofen and Paracetamol on Postoperative Pain and Morphine Consumption in Lumbar Disc Surgery · NA · completed

Other University of Padova trials

Trials by the same sponsor.

NCT07435064 — NURsing-led FRAILty Prevention and Care · NA · not yet recruiting
NCT07283354 — Comparison of Acceleromyography and Electromyography in Obese Patients Undergoing General Anesthesia · not yet recruiting
NCT07259460 — Effects of Dexmedetomidine Target Controlled Infusion on Patient State Index Values and Electroencephalographic Spectrum · recruiting
NCT07385118 — Daily Fluctuations in Brain-Derived Neurotrophic Factor and Cognition: Effects of Vigorous Exercise · NA · completed
NCT07259291 — Minto and Eleveld Remifentanil Target Controlled Infusion (TCI) Models: a Clinical Comparison · 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 NCT02056223 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
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 of Padova
Last refreshed: 4 November 2019

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/NCT02056223.

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