Chronic dry mouth MedDRA version: 7.0 Level: LLT Classification code 10013781
Conditions
Interventions
Product Name: Physostigmine
Product Code: Physostigmine
Pharmaceutical Form: Oromucosal solution
Pharmaceutical form of the placebo: Oromucosal solution
Route of administration of the placebo: Oromuco
Sponsors
Calabar AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects aged 20-70 years who are in good general health but have a history of chronic dry mouth that is corroborated by objective tests of salivation at screening. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Conditions that permanently diminish or block salivation, such as certain chronic illnesses, certain medication and radiotherapy of the head-and-neck region.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To find the optimal dose of physostigmine, providing subjective and objective effects on salivation. ;Secondary Objective: Secondary objectives: To establish the dose dependency of subjective effects on salivation of four different different doses of physostigmine. To assess safety of oromucosal application of physostigmine. ;Primary end point(s): Phase A: Subjective assessments of dryness of the mouth, taste and burning sensation in the mouth after different doses of physostigmine or placebo Phase B: Objective measurement of saliva volume output after an optimal dose of physostigmine or placebo. | — |
Countries
Sweden
Outcome results
None listed