- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02005328
Exploratory Study in the Relief of Drug-induced Xerostomia Associated With Hyposialia
April 14, 2014 updated by: Pierre Fabre Medicament
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.
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Erfurt, Germany
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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Application of product in the mouth twice daily
Application of product in the mouth twice daily
Application of product in the mouth twice daily
Application of product in the mouth twice daily
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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Dry mouth will be self-rated using item "Rate the dryness of your mouth" of the Dry Mouth Visual Analogue Scale questions.
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11 points : from baseline (before application) and up to 4 hours after the first product application
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2013
Primary Completion (Actual)
February 1, 2014
Study Completion (Actual)
February 1, 2014
Study Registration Dates
First Submitted
December 3, 2013
First Submitted That Met QC Criteria
December 3, 2013
First Posted (Estimate)
December 9, 2013
Study Record Updates
Last Update Posted (Estimate)
April 15, 2014
Last Update Submitted That Met QC Criteria
April 14, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- DC0161 BS 0 01
- CIV-13-10-011648 (Other Identifier: EUDAMED)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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