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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Medicament
ClinicalTrials.gov Identifier:
NCT02005328
First received: December 3, 2013
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Drug-induced Xerostomia
Device: Tested product : DC161-DP0291
Device: Tested product : DC161-DP0292
Device: Tested product : DC161-DP0293
Device: Reference product: solution for oromucosal sprays

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
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.

Resource links provided by NLM:


Further study details as provided by Pierre Fabre Medicament:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Dry mouth will be self-rated using item "Rate the dryness of your mouth" of the Dry Mouth Visual Analogue Scale questions.


Enrollment: 40
Study Start Date: December 2013
Study Completion Date: February 2014
Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: cross-over
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.
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005328

Locations
Germany
Erfurt, Germany
Sponsors and Collaborators
Pierre Fabre Medicament
  More Information

No publications provided

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT02005328     History of Changes
Other Study ID Numbers: DC0161 BS 0 01, CIV-13-10-011648
Study First Received: December 3, 2013
Last Updated: April 14, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission

Keywords provided by Pierre Fabre Medicament:
Xerostomia
hyposialia
hyposalivation
saliva substitute
Salivary Gland
Mouth Diseases
Dry mouth

Additional relevant MeSH terms:
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 26, 2014