The aim of this study is to prove the efficacy of 3 times daily 1 mg glycopyrronium bromide admixture versus placebo admixture in patients with PD with hypersalivation. Furthermore, the safety of glycopyrronium bromide used in the mentioned dosage…
ID
Bron
Verkorte titel
Aandoening
Parkinsonian patients with hypersalivation
Ondersteuning
Hospital Medisch Spectrum TwenteDepartment of clinical pharmacy
P.O. Box 50.000
7500 KA Enschede
The Netherlands
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Percentage of patients with a decrease of 3 points on the hypersalivation score (on a scale from 1-9).
Achtergrond van het onderzoek
The aim of this study is to prove the efficacy of 3 times daily 1 mg glycopyrronium bromide versus placebo in patients with PD with hypersalivation. In week 1 there are baseline measurements, in week 2 glycopyrroniumbromide or placebo will be taken, in week 3 there are new baseline measurements, in week 4 cross-over glycopyrroniumbromide or placebo will be taken. The final visit will be in week 5. Patients score the extent of hypersalivation three times a day on a daily basis (scale from 1-9).
Doel van het onderzoek
The aim of this study is to prove the efficacy of 3 times daily 1 mg glycopyrronium bromide admixture versus placebo admixture in patients with PD with hypersalivation. Furthermore, the safety of glycopyrronium bromide used in the
mentioned dosage will be further evaluated. In addition, the aim is to perform a pharmacogenetic analysis with these data within the purpose of this study.
Onderzoeksproduct en/of interventie
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).
Publiek
Department of neurology
P.O. Box 50.000
P.J.E. Poels
Enschede 7500 KA
The Netherlands
+31 53 4872000
Wetenschappelijk
Department of neurology
P.O. Box 50.000
P.J.E. Poels
Enschede 7500 KA
The Netherlands
+31 53 4872000
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL848 |
| NTR-old | NTR862 |
| Ander register | : APOMST001 |
| ISRCTN | ISRCTN28592111 |