Drug-induced Xerostomia Clinical Trial
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.
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | February 2014 |
| Est. primary completion date | February 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Pierre Fabre Medicament |
Germany,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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. | 11 points : from baseline (before application) and up to 4 hours after the first product application | No |