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Note: This record shows only 22 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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EUCTR |
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Last refreshed on:
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19 March 2012 |
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Main ID: |
EUCTR2009-016300-23-GB |
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Date of registration:
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09/11/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Pilot double blind randomised placebo controlled crossover trial of Hyoscine for the treatment of Clozapine induced nocturnal sialorrhoea. - Reducing Excess Salivation Trial (REST)
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Scientific title:
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Pilot double blind randomised placebo controlled crossover trial of Hyoscine for the treatment of Clozapine induced nocturnal sialorrhoea. - Reducing Excess Salivation Trial (REST) |
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Date of first enrolment:
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14/12/2009 |
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Target sample size:
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12 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2009-016300-23 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: yes
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
1. Diagnosis of Schizophrenia or Schizoaffective disorder as per DSM IV-TR criteria.
2. Receiving clozapine for at least two weeks
3. Clozapine dose in the range 200 – 900 mg per day.
4. Able to speak English.
5. Have a minimum score of 2 on the TNHS prior to inclusion in the trial.
6. Adults aged between 18 and 65 years of age
7. Capable of understanding the information given and giving fully informed consent prior to any study specific procedures.
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
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
1. Medical conditions that could influence hypersalivation (e.g. idiopathic Parkinson’s Disease).
2. History of an allergic reaction to hyoscine hydrobromide.
3. Any of the following contra-indications to hyoscine as stated in the British National Formulary and electronic Medicines Compendium:
Prostatic enlargement, myasthenia gravis, pyloric stenosis, paralytic ileus, glaucoma and pregnancy (see appendix C).
4. A woman of childbearing potential, who has tested negative for pregnancy, unable or unwilling to use appropriate contraception during the study.
5. Participation in another therapeutic study within the preceding 12 weeks or use of other investigational drugs or agents.
6. Lack of capacity to provide informed consent to the proposed intervention.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Sialorrhoea in patients treated with clozapine.
MedDRA version: 12.0
Level: LLT
Classification code 10059812
Term: Sialorrhoea
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Intervention(s)
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Trade Name: Kwells
Product Name: Kwells 300 microgram tablets
Pharmaceutical Form: Tablet
INN or Proposed INN: Scopolamine hydrobromide
CAS Number: 114-49-8
Other descriptive name: Hyoscine Hydrobromide
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceutical form of the placebo: Capsule, hard
Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Main Objective: This is a pilot study to obtain data on the efficacy of Hyoscine 0.3mg nocte in reducing salivation at night in patients treated with Clozapine.
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Secondary Objective: To monitor the safety of Hyoscine 0.3mg nocte in patients taking Clozapine with nocturnal sialorrhoea.
To investigate whether quality of life is enhanced by treatment with Hyoscine 0.3mg nocte in patients taking Clozapine with nocturnal sialorrhoea.
To pilot a two new methods of estimating the extent of nocturnal sialorrhoea, by measuring the diameter of the wet patch and the change in mass of the patient’s pillowcase overnight.
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Primary end point(s): Score on the Toronto Nocturnal Hypersalivation Scale each morning
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Secondary ID(s)
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RAA 2009-007
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Source(s) of Monetary Support
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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