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

Primary Purpose

Drug-induced Xerostomia

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Tested product : DC161-DP0291
Tested product : DC161-DP0292
Tested product : DC161-DP0293
Reference product: solution for oromucosal sprays
Sponsored by
Pierre Fabre Medicament
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Drug-induced Xerostomia focused on measuring Xerostomia, hyposialia, hyposalivation, saliva substitute, Salivary Gland, Mouth Diseases, Dry mouth

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

cross-over

Arm 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.

Outcomes

Primary Outcome Measures

Observed area under the curve of dry mouth evaluations
Dry mouth will be self-rated using item "Rate the dryness of your mouth" of the Dry Mouth Visual Analogue Scale questions.

Secondary Outcome Measures

Full Information

First Posted
December 3, 2013
Last Updated
April 14, 2014
Sponsor
Pierre Fabre Medicament
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1. Study Identification

Unique Protocol Identification Number
NCT02005328
Brief Title
Exploratory Study in the Relief of Drug-induced Xerostomia Associated With Hyposialia
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
February 2014 (Actual)
Study Completion Date
February 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pierre Fabre Medicament

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drug-induced Xerostomia
Keywords
Xerostomia, hyposialia, hyposalivation, saliva substitute, Salivary Gland, Mouth Diseases, Dry mouth

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cross-over
Arm Type
Experimental
Arm 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.
Intervention Type
Device
Intervention Name(s)
Tested product : DC161-DP0291
Intervention Description
Application of product in the mouth twice daily
Intervention Type
Device
Intervention Name(s)
Tested product : DC161-DP0292
Intervention Description
Application of product in the mouth twice daily
Intervention Type
Device
Intervention Name(s)
Tested product : DC161-DP0293
Intervention Description
Application of product in the mouth twice daily
Intervention Type
Device
Intervention Name(s)
Reference product: solution for oromucosal sprays
Intervention Description
Application of product in the mouth twice daily
Primary Outcome Measure Information:
Title
Observed area under the curve of dry mouth evaluations
Description
Dry mouth will be self-rated using item "Rate the dryness of your mouth" of the Dry Mouth Visual Analogue Scale questions.
Time Frame
11 points : from baseline (before application) and up to 4 hours after the first product application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Erfurt
Country
Germany

12. IPD Sharing Statement

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

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