Erfurt, Germany
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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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
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
DeviceApplication of product in the mouth twice daily
Tested product : DC161-DP0292
DeviceApplication of product in the mouth twice daily
Tested product : DC161-DP0293
DeviceApplication of product in the mouth twice daily
Reference product: solution for oromucosal sprays
DeviceApplication of product in the mouth twice daily
Primary outcomes
-
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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