The effect of glycopyrroniumbromide oral solution for nocturnal drooling due to the use of clozapine

• Conditions: octurnal sialorrhea caused by the use of clozapine; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2012-002299-15-NL
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-04
• Last Update Posted: 14 September 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

-patients using clozapine who are diagnosed with schizophrenia, a schizoaffective disorder or other psychiatric condition meeting DSM-IV criteria;
-a clozapine dosage that remained unchanged for three months prior to inclusion;
-age between 18 and 65 years;
-nocturnal sialorrhea defined as a score = 2 on the PGI-S (Patient Global Impression of Severity Questionnaire)
-no change in dosages of specific comedication (clonidine, sulpride, moclobemide) that potentially reduces salivary flow for 1 month prior to inclusion
-the patients is able to answer questionnaires during a weekly consultation (by telephone) with the researcher
-the patient is willing and according to the treating physician, able to give informed consent

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 33
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

-known hypersensitivity to glycopyroniumbromide, sorbic acid or saccharine sodium;
-a comorbidity associated with sialorrhea (Parkinsons disease, cerebral palsy);
-one of the following comorbidities: inadequately treated constipation, urine retention, bladder obstruction
-concurrent use of anticholinergic agents: tricyclic antidepressants or anticholinergics (atropine, ipratropiumbromide, trihexyfenidyl,
biperiden, scopolamine, oxybutinine);
-concurrent use of medications that potentially interact with glycopyrroniumbromide
(potassium chloride retard tablets, digoxine, corticosteroids)
-pregnancy or lactation
-a history of myasthenia gravis, cardiac arrhythmia, symptomatic coronary insufficiency, glaucoma, pyloris stenosis, paralytic ileus, prostate hypertrophy, renal failure
-unable to autonomic medication intake

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified