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GUM Hydral Mouthwash vs Placebo in the Management of Hyposalivation.

NCT05103124 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-07-28

No results posted yet for this study

Summary

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.

Conditions

  • Xerostomia
  • Xerostomia Following Radiotherapy

Interventions

DEVICE

Hydral

The investigational product GUM Hydral will be administered for a 30-days treatment period

OTHER

Placebo

The placebo product will be administered for a 30-days treatment period

Sponsors & Collaborators

  • Sunstar Italiana SRL.

    collaborator UNKNOWN

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Carlo Lajolo, Prof. · CU Sacred Hearth

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-03
Primary Completion
2021-12-31
Completion
2022-07-26

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05103124 on ClinicalTrials.gov