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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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Netherlands Trial Register |
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Last refreshed on:
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27 May 2013 |
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Main ID: |
NTR862 |
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Date of registration:
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24/01/2007 |
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Primary sponsor: |
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Public title:
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The effect of glycopyrroniumbromide on hypersalivation in patients with Parkinson's disease: a randomised, cross-over, doubleblind, placebocontrolled trial.
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Scientific title:
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The effect of glycopyrroniumbromide on hypersalivation in patients with Parkinson's disease: a randomised, cross-over, doubleblind, placebocontrolled trial. - Glyspar study |
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Date of first enrolment:
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1/2/2007 |
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Target sample size:
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24 |
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Recruitment status: |
complete |
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URL:
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http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=862 |
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Study type:
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intervention |
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Study design:
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Randomised: Yes; Masking: Triple; Control: Placebo; Group: Crossover; Type: 2 or more arms, randomized
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Countries of recruitment
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The Netherlands
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Contacts
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Name:
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P.J.E.
Poels |
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Address:
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Hospital Medisch Spectrum Twente,
Department of neurology
P.O. Box 50.000
7500 KA
Enschede
The Netherlands |
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Telephone:
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+31 53 4872000 |
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Email:
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Affiliation:
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Name:
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M.E.L.
Arbouw |
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Address:
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Hospital Medisch Spectrum Twente, Department of clinical pharmacy
P.O. Box 50.000
7500 KA
Enschede
The Netherlands |
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Telephone:
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+31 53 4872000 |
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Email:
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m.arbouw@ziekenhuis-mst.nl |
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Affiliation:
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Key inclusion & exclusion criteria
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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: 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.
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Hypersalivation, Parkinson patient
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Intervention(s)
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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 daily).
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Primary Outcome(s)
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Percentage of patients with a decrease of 3 points on the hypersalivation score (on a scale from 1-9).
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Secondary Outcome(s)
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The difference in mean improvement on the hypersalivation score between the two groups. Furthermore, the difference in
reported adverse events will be analysed.
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Secondary ID(s)
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APOMST001
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ISRCTN28592111
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Source(s) of Monetary Support
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Hospital Medisch Spectrum Twente, Department of clinical pharmacy
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