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Trial of Glycopyrronium versus Hyoscine to treat drooling in children - DRI Trial (Drooling Reduction Intervention)

A single blind study comparing the efficacy of Glycopyrronium and Hyoscine on drooling in children with neurodisability - DRI Trial (Drooling Reduction Intervention)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN75287237
Enrollment
90
Registered
2013-07-22
Start date
2013-09-01
Completion date
Unknown
Last updated
2018-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Medicines for Children Research Network

Interventions

Primary Intervention, Commencement of Glycopyrronium oral medication or Hyoscine patch. Secondary intervention, Adjustments to dosing of Glycopyrronium or Hyoscine. Tertiary Intervention, Appointment

Sponsors

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Treatment naive children, with nonprogressive neurodisability, who require Glycopyrronium or Hyoscine to reduce drooling 2. No contraindication to either medication 3. Age between 36 months and below 16 years; Target Gender: Male & Female

Exclusion criteria

Exclusion criteria: 1. Children who have received medical or surgical interventions for drooling 2. Children with medical conditions for which either medication is contraindicated 3. Children whose parents are considered unable to follow the study protocol 4. Parents without mobile or home telephone (required for communication with research registrar and assistant) 5. Parents whose use of English would not allow them to understand the issues in the 6. Consent form or be able to take part in the phone calls with the Trial Research Paediatrician and Trial Outcome Assessor

Design outcomes

Primary

MeasureTime frame
Drooling Impact Scale score at 4 weeks

Secondary

MeasureTime frame
Not provided at time of registration

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 8, 2026