Home » Trials » SLCTR/2012/008
A study to determine the therapeutic value of the prokinetic drug- domperidone to improve gastric motility in children with abdominal pain predominant functional gastrointestinal disorders (FGD)
-
SLCTR Registration Number
SLCTR/2012/008
Date of Registration
The date of last modification
Mar 03, 2019
Trial Status
Scientific Title of Trial
A study to determine the therapeutic value of the prokinetic drug- domperidone to improve gastric motility in children with abdominal pain predominant functional gastrointestinal disorders (FGD)
Public Title of Trial
Use of domperidone in children with abdominal pain
Disease or Health Condition(s) Studied
Abdominal pain predominant functional gastrointestinal disorders in children
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
None
Any other number(s) assigned to the trial and issuing authority
P014/03/2011 (Ethics Review Committee of the Faculty of Medicine, University of Kelaniya)
What is the research question being addressed?
Does the prokinetic drug - domperidone improve abdominal pain predominant functional gastrointestinal disorders (FGD) in children by normalizing gastric motility?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Double blinded
Control
Placebo
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
The intervention group will receive domperidone 10mg as oral tablets (brand name Motilium®) 3 times per day 15 minutes before meals, while control group receives a placebo 3 times per day 15 minutes before meals for 8 weeks. A diary will be provided to document severity, frequency and duration of symptoms and interruption of activities. Gastric motility studies will be repeated at 8th week
Inclusion criteria
Age between 5-12 years Children who fulfil the Rome III criteria for abdominal pain related FGD Children with abdominal pain at least once per week for at least 2 months prior to diagnosis Pain severity more than 25% on visual analogue scale pain interrupt the activities of the child (e.g. sleep, play, schooling etc) Written informed consent from parents or legally-accepted guardians
Exclusion criteria
Clinical or laboratory evidence suggesting organic pathology Chronic medical or surgical disease other than FGD Long-term medication for any illness other than FGD Previous abdominal surgery except appendectomy Use of prokinetic drugs or any other drugs that can alter gastrointestinal motility during the within 30 days prior to the diagnosis
Primary outcome(s)
|
1.
Cure i.Less than 4 episodes of abdominal pain per month ii.Severity of abdominal pain less than 25mm in the visual analogue scale iii.No interruption of activities due to abdominal pain |
[ 8 weeks after the intervention ] |
|
2.
Improvement : based on responses to 2 questions i.Overall how do you feel your problem is? Answer will be better, same or worse. “Better” will be regarded as positive result. “Same” or “worse” will be regarded as negative result ii.How did the medication relieve your pain? Sense of improvement will be expressed as excellent, good, fair and poor. Excellent and good will be considered as positive result. fair and poor will be considered as negative result. |
[ 8 weeks after the intervention ] |
Secondary outcome(s)
|
1.
Improvement of quality of life using the PredsQL Paediatric Quality of Life Inventory - version 4 for young child report (ages 5 - 7 years) and child report (ages 8 -12 years) |
[ At baseline and at 8 weeks after commencement ] |
|
2.
Decrease impact on the family using the PredsQL Family Impact Module - version 2, parent report will be used |
[ At baseline and at 8 weeks after commencement ] |
|
3.
Improvement of gastric motility using gastric emptying rate and antral motility index. An increase of 25% or more from baseline in the above motility parameters will be considered as improvement |
[ At baseline and at 8 weeks after commencement ] |
|
4.
Tolerability of intervention: any specified, severe or unexpected adverse reactions among all those allocated study treatment compared to placebo |
[ At baseline and at 8 weeks after commencement ] |
Target number/sample size
100 Children
Countries of recruitment
Sri Lanka
Anticipated start date
2012-09-01
Anticipated end date
2012-12-31
Date of first enrollment
2012-09-13
Date of study completion
Recruitment status
Recruiting
Funding source
None
Regulatory approvals
Status
Approved
Date of Approval
2011-09-14
Approval number
P014/03/2011
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medicine, University of Kelaniya |
| Institutional Address: | PO Box 6, Thalagolla Road, Ragama Sri Lanka |
| Telephone: | +94-11-2961267 |
| Email: | erckelaniya@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. Shaman Rajindrajith
Senior Lecturer and Consultant Paediatrician
Department of Paediatrics ,
Faculty of Medicine University of Kelaniya
Thalagolla road Ragama Sri Lanka
94-11-2961116, 94-11- 295833
94-777-955606
Office – rajindrajith@mfac.kln.ac.lk Personal – shamanr0@lycos.com
Contact Person for Public Queries
Prof. Asitha de Silva
Professor
Department of Pharmacology,
Faculty of Medicine University of Kelaniya
94 11 2959261 +94 11 2856263 94-11- 2958337
+94 77 7377227
asita@sltnet.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
