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Exploratory Study in the Relief of Drug-induced Xerostomia Associated With Hyposialia

NCT02005328 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-04-15

No results posted yet for this study

Summary

The purpose of this study is to evaluate the clinical efficacy, the safety and acceptability of three new oral sprays with a reference oral spray in the relief of drug-induced xerostomia associated with hyposialia, i.e. dryness of the mouth induced by a decrease of salivation (hyposialia) induced by chronic drug intake.

Conditions

  • Drug-induced Xerostomia

Interventions

DEVICE

Tested product : DC161-DP0291

Application of product in the mouth twice daily

DEVICE

Tested product : DC161-DP0292

Application of product in the mouth twice daily

DEVICE

Tested product : DC161-DP0293

Application of product in the mouth twice daily

DEVICE

Reference product: solution for oromucosal sprays

Application of product in the mouth twice daily

Sponsors & Collaborators

  • Pierre Fabre Medicament

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • Germany

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 NCT02005328 on ClinicalTrials.gov