Trial of Glycopyrronium versus Hyoscine to treat drooling in children - DRI Trial (Drooling Reduction Intervention)
| ISRCTN | ISRCTN75287237 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN75287237 |
| EudraCT/CTIS number | 2013-000863-94 |
| Secondary identifying numbers | 14956 |
- Submission date
- 22/07/2013
- Registration date
- 22/07/2013
- Last edited
- 15/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Mrs Joanne Morrison
Scientific
Scientific
4th Floor William Leech Building
Framlington Place
Newcastle Upon Tyne
NE2 4HH
United Kingdom
| joanne.morrison@newcastle.ac.uk |
Study information
| Study design | Randomised interventional trial; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | A single blind study comparing the efficacy of Glycopyrronium and Hyoscine on drooling in children with neurodisability - DRI Trial (Drooling Reduction Intervention) |
| Study acronym | DRI |
| Study objectives | 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. |
| Ethics approval(s) | 13/NE/0078 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Glycopyrronium, Hyoscine |
| Primary outcome measure | Drooling Impact Scale score at 4 weeks |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/2013 |
| Completion date | 30/09/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 36 Months |
| Upper age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 90; UK Sample Size: 90 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/09/2013 |
| Date of final enrolment | 30/09/2014 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
4th Floor William Leech Building
Newcastle Upon Tyne
NE2 4HH
United Kingdom
NE2 4HH
United Kingdom
Sponsor information
Newcastle upon Tyne Hospitals NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
New Victoria Wing
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
England
United Kingdom
| Website | http://www.newcastle-hospitals.org.uk/ |
|---|---|
"ROR" |
https://ror.org/05p40t847 |
Funders
Funder type
Charity
Castang Foundation (UK)
No information available
Royal College of Paediatrics and Child Health (UK)
Private sector organisation / Associations and societies (private and public)
Private sector organisation / Associations and societies (private and public)
- Alternative name(s)
- RCPCH
- Location
- United Kingdom
WellChild Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 17/02/2014 | Yes | No | |
| Results article | results | 01/04/2018 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
15/02/2018: Publication reference added.
