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
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
-
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.