Research with human participants

Overview of medical research in the Netherlands

Effect of domperidone and omeprazole in gastro-oesophageal reflux disease in infants between 0 and 2 years.

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Last updated:

To measure the effect of domperidone and omeprazole on reflux-time, duration, and symptoms of GERD

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Ethical review
Approved WMO
Status
Recruitment stopped
Health condition type
Gastrointestinal signs and symptoms
Study type
Interventional

ID

NL-OMON37309

Source

ToetsingOnline

Brief title

Treatment with domperidone and omeprazole in GERD

Condition

  • Gastrointestinal signs and symptoms

Synonym

GERD (=gastro-esophageal reflux disease), reflux

Research involving

Human

Sponsors and support

Primary sponsor :
Flevoziekenhuis
Source(s) of monetary or material Support :
De ziektekostenverzekeraar van de kinderen;die worden gezien door de kinderartsen;het betreft een reguliere diagnostiek en behandeling van kinderen met gastroesofageale reflux.

Intervention

Keyword :
domperidone, Gastro oesophageal reflux disease, infants, omeprazole

Outcome measures

Primary outcome

Change in reflux time, reflux duration and symptoms before and after treatment

as measured by 24-h oesophageal pH monitoring, questionnairies, patient

controle

Secondary outcome

Physical examination, growth, laboratory results.

Background summary

Gastro-oesophageal reflux disease (GERD) is a common disease in infants between
0-2 years of age. GERD is diagnosed by a (golden standard). In case of GERD
these infants are treated with dompridone and omeprazole. Is is unclear however
if and to which degree these medicines and/or the combination of these
medicines have effect on the oesophageal refluxtime and duration (as measured
bij 24-h oesophageal pH monitoring). And what the effect is on the symptoms in
infants between 0-2 years of age with GERD. With this study we want to measure
the effect of medication on the symptoms of GERD in infants. Our hypothesis is
that the combination of omeprazole and domperidone has a positive effect on the
symptoms of GERD in infants between 0-2 years of age.

Study objective

To measure the effect of domperidone and omeprazole on reflux-time, duration,
and symptoms of GERD

Study design

Open randomised controlled trial

Intervention

One group uses 1 mg/kg domperidone suspension (4dd), one group uses 2-3 mg/kg
omeprazole mups (2dd) and one group with both domperidone and omeprazole.

Study burden and risks

Except for one extra 24-h oesophageal pH monitoring, this study results in no
extra burden to the patients. The burden of a 24-h oesophageal pH monitoring is
minimal, and there are no risks. We foresee no risks of the medicines that are
used in this study, because these are registered medicines that are used within
the indication range.

Public
Flevoziekenhuis

Hospitaalweg 1
1315 RA Almere
NL
Scientific
Flevoziekenhuis

Hospitaalweg 1
1315 RA Almere
NL

Listed location countries

Netherlands

Age

Children (2-11 years)

Inclusion criteria

Gastro-oesophageal reflux disease diagnosed by 24-h oesophageal pH monitoring

Exclusion criteria

1. Gastro-oesophageal reflux disease for which treatment has started. 2. Infants with gastro-oesophageal reflux disease presenting with an apparant life threatening event (ALTE)

Design

Study type :
Interventional
Intervention model
:
Parallel
Allocation :
Randomized controlled trial
Masking :
Open (masking not used)
Control :
Active
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruitment stopped
Start date (anticipated) :
Enrollment :
90
Type :
Actual

Medical products/devices used

Product type :
Medicine
Brand name :
losec-mups
Generic name :
omeprazole
Registration
:
Yes - NL intended use
Product type :
Medicine
Brand name :
motilium
Generic name :
domperidon
Registration
:
Yes - NL intended use

Approved WMO
Date :
Application type :
First submission
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
Application type :
First submission
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)
Approved WMO
Date :
Application type :
Amendment
Review commission :
MEC-U: Medical Research Ethics Committees United (Nieuwegein)

Followed up by the following (possibly more current) registration

No registrations found.

Other (possibly less up-to-date) registrations in this register

No registrations found.

In other registers

Register ID
EudraCT EUCTR2007-003067-46-NL
CCMO NL16923.067.07