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Metoclopramide for Clozapine-induced Hypersalivation
NCT02222220Phase 3
Key facts
- Status
- Completed
- Start
- Jan 2012
- Primary completion
- May 2014
- Countries
- 1
- Sponsor
- Be'er Sheva Mental Health Center
- Modality
- Small Molecules
- Drugs
- metoclopramide
- Conditions
- clozapine-induced hypersalivation (CIS)
01
Overview
Phase 3, randomised, double-blind trial in clozapine-induced hypersalivation (CIS) comparing Metoclopramide with Placebo (2 arms). Primary endpoint: Nocturnal Hypersalivation Rating Scale at 4 weeks. Started Jan 2012; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Metoclopramide
Metoclopramide add-on to Clozapine
Placebo
Placebo add-on to Clozapine
03
Who it enrols
Patients with schizophrenia or schizoaffective disorder treated with clozapine for at least 2 months and suffering from hypersalivation (NHRS > 2).
04
Endpoints
Primary
Nocturnal Hypersalivation Rating Scale
Secondary
Drooling Severity Scale
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