EUCTR2013-000863-94-GBActive, not recruitingPhase 1
A single blind study comparing the efficacy of Glycopyrronium and Hyoscine on drooling in children with neurodisability - DRI Trial (Drooling Reduction Intervention) - Trial of Glycopyrronium versus Hyoscine to treat drooling in children
ewcastle upon Tyne Hospitals NHS Foundation Trust0 sites90 target enrollmentStarted: September 2, 2013Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 90
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •- Treatment naive children, with non-progressive neurodisability, who require Glycopyrronium or Hyoscine to reduce drooling
- •- No contra-indication to either medication
- •- Age between 36 months and below 16 years
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 90
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 0
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 0
Exclusion Criteria
- •- Children who have received medical or surgical interventions for drooling
- •- Children with medical conditions for which either medication is contraindicated
- •- Children whose parents are considered unable to follow the study protocol
- •- Parents without mobile or home telephone (required for communication with research registrar and assistant)
- •- Parents whose use of English would not allow them to understand the issues in the Consent form or be able to take part in the phone calls with the Trial Research Paediatrician and Trial Outcome Assessor.
Investigators
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