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

Pierre Fabre logo

Pierre Fabre

Status

Completed

Conditions

Drug-induced Xerostomia

Treatments

Device: Reference product: solution for oromucosal sprays
Device: Tested product : DC161-DP0293
Device: Tested product : DC161-DP0292
Device: Tested product : DC161-DP0291

Study type

Interventional

Funder types

Industry

Identifiers

NCT02005328
CIV-13-10-011648 (Other Identifier)
DC0161 BS 0 01

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

40 participants in 1 patient group

cross-over
Experimental group
Description:
Four periods separated by a wash out lasting up to 3 days at maximum. At each period, application of one product (twice). Duration of treatment period: From 4 to 13 days.
Treatment:
Device: Tested product : DC161-DP0292
Device: Tested product : DC161-DP0291
Device: Tested product : DC161-DP0293
Device: Reference product: solution for oromucosal sprays

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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