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Ipratropium Bromide Spray for Sialorrhea in Parkinson's Disease
NCT00296946Phase 2
Key facts
- Status
- Completed
- Start
- Nov 2004
- Countries
- 1
- Sponsor
- University Health Network
- Modality
- Small Molecules
- Drugs
- ipratropium bromide
- Conditions
- sialorrhea
01
Overview
Phase 2, randomised, double-blind trial of ipratropium bromide in sialorrhea (2 arms), sponsored by University Health Network. Primary endpoint: Objective measure of saliva production at 2 weeks. Started Nov 2004; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Ipratropium then Placebo
Patients receive Ipratropium Bromide spray in Period 1 and Placebo spray in Period 2.
Placebo then Ipratropium
Patients receive Placebo spray in Period 1 and Ipratropium Bromide spray in Period 2.
03
Who it enrols
Patients with idiopathic Parkinson's disease and bothersome drooling (UPDRS item 6 >= 2), on stable medication for 1 month. Excludes those on cholinergic/anticholinergic drugs, or with glaucoma, urinary retention, psychosis, or peanut/soy allergy.
04
Endpoints
Primary
Objective measure of saliva production
Secondary
Subjective measure of saliva using diaries
United Parkinson's Disease Rating Scale parts I - IV
Adverse events
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