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Completed

NCT Number: NCT02005328

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erfurt, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tested product : DC161-DP0291

Device

Application of product in the mouth twice daily

Tested product : DC161-DP0292

Device

Application of product in the mouth twice daily

Tested product : DC161-DP0293

Device

Application of product in the mouth twice daily

Reference product: solution for oromucosal sprays

Device

Application of product in the mouth twice daily

Primary outcomes

  1. Observed area under the curve of dry mouth evaluations

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Pierre Fabre Medicament

Industry

Registry information

Official study title

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.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 9, 2013
Registry last updated
Apr 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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