NCT05103124 is a NA clinical trial of Hydral in Xerostomia, sponsored by Catholic University of the Sacred Heart.

Who is sponsoring NCT05103124?

NCT05103124 is sponsored by Catholic University of the Sacred Heart.

What drugs are being tested in NCT05103124?

Interventions in NCT05103124: Hydral, Placebo.

What condition does NCT05103124 study?

NCT05103124 studies Xerostomia, Xerostomia Following Radiotherapy.

Is NCT05103124 still recruiting?

NCT05103124 is currently completed. Last updated 28 July 2022.

Last reviewed 2022-07-28 · How we verify

NCT05103124

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

GUM Hydral Mouthwash vs Placebo in the Management of Hyposalivation.

Completed NA Last updated 28 July 2022

What this trial tests

NA trial testing Hydral in Xerostomia in 40 participants. Completed in 26 July 2022.

Timeline

3 November 2020

Primary endpoint
31 December 2021

26 July 2022

Quick facts

Lead sponsor	Catholic University of the Sacred Heart
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	treatment
Enrollment	40
Start date	3 November 2020
Primary completion	31 December 2021
Estimated completion	26 July 2022
Sites	1 location across Italy

Drugs / interventions tested

Hydral
Placebo

Conditions studied

Xerostomia — all drugs for Xerostomia →
Xerostomia Following Radiotherapy — all drugs for Xerostomia Following Radiotherapy →

Sponsor

Catholic University of the Sacred Heart

Who can join

18 and older, any sex, with Xerostomia or Xerostomia Following Radiotherapy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

There is currently little robust evidence to inform the management of hyposalivation and xerostomia in this population. Although the treatment of xerostomia is very individual, a first-line medication is needed to ameliorate the dehydration in the mouth by substituting for the secretion of saliva. The aim of this study is to describe the effect of the administration of Hydral on reducing patients' xerostomia symptoms due to radiotherapy. The study will be conducted as a double-blind randomized clinical trial (RCT) and foresees a crossover design, so the population will be divided into two groups, receiving both the medical device and the placebo.

Publications & conference data

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

Sodium-hyaluronate mouthwash on radiotherapy-induced xerostomia: a randomised clinical trial.
Rupe C, Basco A, Gioco G, Patini R, et al · · 2023 · cited 3× · PMID 37851095 · DOI 10.1007/s00520-023-08090-x
Sodium-hyaluronate Mouthwash on Radiotherapy-induced Xerostomia: a Randomized Clinical Trial
Rupe C, Basco A, Gioco G, Patini R, et al · · 2023 · DOI 10.21203/rs.3.rs-2583397/v1

Verify or expand the search:

Other recruiting trials for Xerostomia

Currently open trials in the same condition.

NCT07394842 — Longitudinal Oral Health Changes After Head and Neck Radiotherapy · active not recruiting
NCT06465628 — Acupressure on Xerostomia in Head and Neck Cancer Patients · NA · recruiting
NCT06365047 — Dry Mouth Toothpaste Study - Comparing Two Toothpastes With Arginine · Phase 3 · active not recruiting
NCT06194123 — Effect of Whitening Agent With Emulsion Gel in Saliva and Halitosis · NA · active not recruiting
NCT06287294 — An Investigation Into Taste Problems Associated With Xerostomia in Patients With Advanced Cancer · recruiting

Other Catholic University of the Sacred Heart trials

Trials by the same sponsor.

NCT07476599 — The OB-WELL Project, a Randomized Controlled Trial of an Internet-Based Self-Help System for Psychological Support in Ob · NA · not yet recruiting
NCT07516392 — Study of a Polygenic Risk Score to Predict the Risk of Pancreatic Ductal Adenocarcinoma · NA · not yet recruiting
NCT07140705 — Personalized Virtual Reality for Promoting Well-Being and Psychological Flexibility in General Practitioners · NA · completed
NCT06992453 — Multi-omics Dissection of Gut Microbiome Engraftment During FMT · NA · not yet recruiting
NCT06852183 — Restructuring Body Experience in Anorexia Nervosa: Virtual Reality Functionality-Focused Mirror Exposure · 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 NCT05103124 (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 Catholic University of the Sacred Heart
Last refreshed: 28 July 2022

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/NCT05103124.

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