NCT02783378

Brief Summary

At a esophagal pH-monitoring will the classic 24-hour measurement be extended to 48 hours. During the first 24 hours are the measurements without medication. After 24 hours the treatment will be started with Gaviscon and will the next 24 hours the measurements under the medication happen. Normally is the medication required after the measurements. With this study the investigators will have multiple measurement points to compare.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 13, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

May 8, 2018

Status Verified

May 1, 2018

Enrollment Period

1.4 years

First QC Date

May 13, 2016

Last Update Submit

May 2, 2018

Conditions

Gastroesophageal Reflux

Keywords

impedance metrygaviscon

Outcome Measures

Primary Outcomes (1)

  • Incidence of pathological GERD

    change in pathological GERD from baseline at 24 and 48 hours

    24 and 48 hours

Secondary Outcomes (2)

  • Effect of Gaviscon on pain in infants with GERD

    24 and 48 hours

  • Effect of Gaviscon on parental concern for parents of infants with GERD

    24 hours and 48 hours

Study Arms (1)

Gaviscon syrup

OTHER

Gaviscon will be given to threat patients with reflux after first 24 hours of oesophagal pH-monitoring. This is a syrup and will be given after every meal. dosage depends from age between 1ml and 5ml after every meal

Drug: Gaviscon Syrup

Interventions

Gaviscon SyrupDRUG
Also known as: natriumalginaat and natriumbicarbonaat, BE386802.
Gaviscon syrup

Eligibility Criteria

AgeUp to 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children in whom a pH-monitoring was asked
  • pre school-age children
  • hospitalized children
  • parents have the informed consent signed.

You may not qualify if:

  • children over 6 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UZ Brussel

Brussels, 1090, Belgium

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr

Study Record Dates

First Submitted

May 13, 2016

First Posted

May 26, 2016

Study Start

February 24, 2016

Primary Completion

August 1, 2017

Study Completion

December 31, 2017

Last Updated

May 8, 2018

Record last verified: 2018-05

Locations

BE(1)