We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02005328
First Posted: December 9, 2013
Last Update Posted: April 15, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Pierre Fabre Medicament
  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
Intervention Model: Crossover Assignment
Masking: None (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 ]
    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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005328


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

Responsible Party: Pierre Fabre Medicament
ClinicalTrials.gov Identifier: NCT02005328     History of Changes
Other Study ID Numbers: DC0161 BS 0 01
CIV-13-10-011648 ( Other Identifier: EUDAMED )
First Submitted: December 3, 2013
First Posted: December 9, 2013
Last Update Posted: April 15, 2014
Last Verified: April 2014

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