E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Sialorrhoea in patients treated with clozapine. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10059812 |
E.1.2 | Term | Sialorrhoea |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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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E.2.2 | Secondary objectives of the trial |
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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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Score on the Toronto Nocturnal Hypersalivation Scale each morning |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Completion of all trial procedures by the last participant. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |