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

Not Applicable

Completed

• Conditions: Drug-induced Xerostomia

• Registration Number: NCT02005328
• Lead Sponsor: Pierre Fabre Medicament

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-09
• Primary Completion: 2014-02
• Study Completion: 2014-02
• Status Verified: 2014-04
• Last Update Submitted: 2014-04-14
• Last Update Posted: 2014-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Male and female subjects,
• Adult subjects (≥18 years) taking drug(s) causing salivary hypofunction / xerostomia, for at least 1 week prior to study initiation and expected to continue without change during study
• Subjects with a complaint of dry mouth as assessed by a response of 40mm or greater on item "Rate the dryness of your mouth" of the Dry Mouth Visual Analogue Scale (VAS) questions. (The VAS limits will be 0 representing normal [i.e. no dry mouth symptoms] and 100 representing "the worst imaginable" dry mouth symptoms). This score should also be met before the 1st product application, on P1 D1.
• Documented hyposalivation with test of resting saliva weight absorbed ≤ 0.5g/5 min at baseline

Exclusion Criteria

• Presence of disorders (bucco-dental disease, history of major medical/psychiatric illness or surgery, ... ) which, in the judgement of the investigator, may interfere with study implementation and/or study parameter assessment(s).
• Sjögren syndrome and related autoimmune diseases,
• Other medical causes of xerostomia (oral candidiasis).
• History of head and neck irradiation and cancer chemotherapy
• History of hypersensitivity to any of the components of the investigational products,
• History or current excessive use of alcohol,
• History of drug addiction,
• Presence of treatments for their dry mouth within 7 days prior to inclusion into the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Observed area under the curve of dry mouth evaluations	11 points : from baseline (before application) and up to 4 hours after the first product application	Dry mouth will be self-rated using item "Rate the dryness of your mouth" of the Dry Mouth Visual Analogue Scale questions.