Skip to content

The effect of glycopyrroniumbromide on hypersalivation in patients with Parkinson's disease: a randomised, cross-over, doubleblind, placebocontrolled trial.

The effect of glycopyrroniumbromide on hypersalivation in patients with Parkinson's disease: a randomised, cross-over, doubleblind, placebocontrolled trial.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20228
Enrollment
24
Registered
2007-01-24
Start date
2007-02-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinsonian patients with hypersalivation

Interventions

Cross over design: In week 2 glycopyrroniumbromide (3 times 1mg=5ml daily) or placebo (3 times 5ml daily ). In week 4 cross-over glycopyrroniumbromide (3 times 1mg=5ml daily) or placebo (3 times 5ml d

Sponsors

M.E.L. Arbouw, Hospital Medisch Spectrum TwenteDepartment of clinical pharmacy P.O. Box 50.000 7500 KA Enschede The Netherlands
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients with Parkinson's disease; 2. Age >=18 years; 3. Hypersalivation score >=5 (on a scale from 1-9); 4. Patient or family is able to score the extent of hypersalivation.

Exclusion criteria

Exclusion criteria: 1. Hypersensitivity to glycopyrronium bromide, sorbic acid or saccharin sodium; 2. Myasthenia gravis; 3. Symptomatic tachycardia; 4. Coronary insufficiency; 5. Heart rythm disorders; 6. Glaucoma; 7. Pylorus stenosis; 8. Paralytic ileus; 9. Prostate hypertrophy; 10 Patients using potassiumchloride tablets, oral digoxin or oral corticosteroids; 11. Kidney function disorders; 12. Pregnancy or lactation.

Design outcomes

Primary

MeasureTime frame
Percentage of patients with a decrease of 3 points on the hypersalivation score (on a scale from 1-9).

Secondary

MeasureTime frame
The difference in mean improvement on the hypersalivation score between the two groups. Furthermore, the difference in reported adverse events will be analysed.

Contacts

Public ContactP.J.E. Poels

Hospital Medisch Spectrum Twente, Department of neurology P.O. Box 50.000

+31 53 4872000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)