NCT02005328

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

Study of the Effect and Safety of Three New Oral Sprays and a Reference Marketed Oral Spray in the Relief of Drug-induced Xerostomia Associated With Hyposialia.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Pierre Fabre Medicament · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2013-12-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2013-12-09
• Last updated: 2014-04-15

Locations

1 site across 1 country: Germany