Condition category
Nervous System Diseases
Date applied
22/07/2013
Date assigned
22/07/2013
Last edited
19/02/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Joanne Morrison

ORCID ID

Contact details

4th Floor William Leech Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
joanne.morrison@newcastle.ac.uk

Additional identifiers

EudraCT number

2013-000863-94

ClinicalTrials.gov number

Protocol/serial number

14956

Study information

Scientific title

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

Acronym

DRI

Study hypothesis

Drooling is a common problem in children with neurodisabilities such as cerebral palsy or Down Syndrome. Drooling leads to the facial skin becoming sore, frequent changes of clothes, damage to educational equipment, and often social embarrassment for the child and family. There is no evidence about the relative effectiveness of the two medications most commonly used to reduce drooling.

This study aims to identify:
- whether Glycopyrronium or Hyoscine is more effective and at what dose
- side-effects of the medications and how these relate to dose

Over 9 months paediatricians, with special interest in neurodisability working in 15 UK centres, will recruit 90 children from outpatient clinics; these children will not have received any medication for drooling. Children will have a non-progressive neurodisability and be less that 16 years old. They will have no contraindications to the medications. Children will be randomised for treatment and medication will be increased, as tolerated for 4 weeks; this will be under the guidance of the Trial Research Paediatrician, working to the study protocol.

The Trial Outcome Assessor will collect outcome data before the intervention and then at 4, 12 and 52 weeks. Well established scales of the impact of the medication on family and child will be used. Children of sufficient age and ability (identified with help of local paediatrician and the family) will be asked for their own views in an interview.

The results will lead to guidance on: drug doses, intervals for increasing medication, and monitoring of adverse effects. The results have the potential to be adopted immediately because the medications are already in use and surveys of parents and professionals, before the study started, indicates that this trial is needed and the results anticipated with interest.

The overall study duration will be 2 years.

More details can be found at: http://public.ukcrn.org.uk/search/StudyDetail.aspx?StudyID=14956

Ethics approval

13/NE/0078

Study design

Randomised interventional trial; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Medicines for Children Research Network; Subtopic: All Diagnoses; Disease: All Diseases

Intervention

Primary Intervention, Commencement of Glycopyrronium oral medication or Hyoscine patch.

Secondary intervention, Adjustments to dosing of Glycopyrronium or Hyoscine.

Tertiary Intervention, Appointment to decide on ongoing treatment after 12 weeks.

Intervention type

Drug

Phase

Phase IV

Drug names

Glycopyrronium, Hyoscine

Primary outcome measures

The primary clinical endpoint is the Drooling Impact Scale score at 4 weeks

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2013

Overall trial end date

30/09/2014

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Planned Sample Size: 90; UK Sample Size: 90

Participant 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.

Recruitment start date

01/09/2013

Recruitment end date

30/09/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

4th Floor William Leech Building
Newcastle Upon Tyne
NE2 4HH
United Kingdom

Sponsor information

Organisation

Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)

Sponsor details

New Victoria Wing
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.newcastle-hospitals.org.uk/

Funders

Funder type

Charity

Funder name

Castang Foundation (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Royal College of Paediatrics and Child Health (UK)

Alternative name(s)

RCPCH

Funding Body Type

private sector organisation

Funding Body Subtype

professional associations and societies

Location

United Kingdom

Funder name

WellChild Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24533890

Publication citations

  1. Results

    Parr JR, Weldon E, Pennington L, Steen N, Williams J, Fairhurst C, O'Hare A, Lodh R, Colver A, The drooling reduction intervention trial (DRI): a single blind trial comparing the efficacy of glycopyrronium and hyoscine on drooling in children with neurodisability., Trials, 2014, 15, 60, doi: 10.1186/1745-6215-15-60.

Additional files

Editorial Notes