Gastroesophageal RefluxNCT02783378
48 Hours Esophagal pH-monitoring With and Without Gaviscon
A study testing Gaviscon Syrup in people with Gastroesophageal Reflux, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 6 years
- Conditions the study is for
- Gastroesophageal Reflux
- What is being tested?
- Gaviscon Syrup
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 24 Feb 2016to 31 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 6 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- children in whom a pH-monitoring was asked
- pre school-age children
- hospitalized children
- parents have the informed consent signed.
Who cannot join
- children over 6 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 48 Hoursesophagal pH-monitoring With and Without Gaviscon
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.
Read the detailed description
This is an interventional, with questionnaires. 25 participants will be included.
Parents and children must be willing to have the esophagal pH-monitoring for 48 hours instead of 24 hours.
The restrictions are (like any other esophagal pH-monitoring) :
Do not detach the probe, no bath or shower, no bouncy castle, no swimming pool, ....
Give your child time to get used to the probe. Give your child no carbonated beverages, limit sweets, avoid chewing gum!
Not study specific procedures : there will be placed a probe for the oesophagal pH-monitoring and this will be checked on children's radiology.
study specific procedures : questionnaires at specific times : Before start : SF 36 Every 6 hours during 48hours : FLACC Satisfaction scale at the start, after 1 day and after 2 days
Flowchart time 0: obtaining ICF, signed by both parents, placing of probe, explanation of questionnaires, completing SF36 and satisfaction scale time 6: FLACC time 12: FLACC time 18: FLACC time 24: FLACC, satisfaction scale, reading out pH monitoring from the first 24 hours, then starting of Gaviscon in function of the result. The Gaviscon is supplied by the service, at no cost to the patient time 30: FLACC time 36: FLACC time 42: FLACC time 48: FLACC, satisfaction scale, remove pH monitoring
Calculation of the number of participants :
since there is never such a study was carried out, we started this pilot study. An analysis will be carried out after 15 patients.
Analysis of the results :
the results of the first and second 24 hour data will be compared (automatically by computer analysis).
- Conditions
- Gastroesophageal Reflux
- Being tested
- Gaviscon Syrup
- Keywords
- impedance metry, gaviscon
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gaviscon SyrupDrug
Also called natriumalginaat and natriumbicarbonaat, BE386802.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Gaviscon Syrup |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of pathological GERD
change in pathological GERD from baseline at 24 and 48 hours
Measured: 24 and 48 hours
Secondary outcomes (2)
Effect of Gaviscon on pain in infants with GERD
Pain assessed via FLACC scale
Measured: 24 and 48 hours
Effect of Gaviscon on parental concern for parents of infants with GERD
Parental concern assessed via 10 point Likert scale
Measured: 24 hours and 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2016 (estimated)
- Study start24 Feb 2016
- Primary completion1 Aug 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yvan Vandenplas, Universitair Ziekenhuis Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02783378
- Sponsor's protocol ID
- B.U.N. 143201627026
- Status last verified
- May 2018
- First submitted
- 13 May 2016
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 48 Hoursesophagal pH-monitoring With and Without Gaviscon
- ClinicalTrials.gov ID
- NCT02783378
- Acronym / sponsor ID
- B.U.N. 143201627026
- Conditions
- Gastroesophageal Reflux
- Keywords
- impedance metry, gaviscon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 24 Feb 2016 (actual)
- Primary completion
- 1 Aug 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 26 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an interventional, with questionnaires. 25 participants will be included.
Parents and children must be willing to have the esophagal pH-monitoring for 48 hours instead of 24 hours.
The restrictions are (like any other esophagal pH-monitoring) :
Do not detach the probe, no bath or shower, no bouncy castle, no swimming pool, ....
Give your child time to get used to the probe. Give your child no carbonated beverages, limit sweets, avoid chewing gum!
Not study specific procedures : there will be placed a probe for the oesophagal pH-monitoring and this will be checked on children's radiology.
study specific procedures : questionnaires at specific times : Before start : SF 36 Every 6 hours during 48hours : FLACC Satisfaction scale at the start, after 1 day and after 2 days
Flowchart time 0: obtaining ICF, signed by both parents, placing of probe, explanation of questionnaires, completing SF36 and satisfaction scale time 6: FLACC time 12: FLACC time 18: FLACC time 24: FLACC, satisfaction scale, reading out pH monitoring from the first 24 hours, then starting of Gaviscon in function of the result. The Gaviscon is supplied by the service, at no cost to the patient time 30: FLACC time 36: FLACC time 42: FLACC time 48: FLACC, satisfaction scale, remove pH monitoring
Calculation of the number of participants :
since there is never such a study was carried out, we started this pilot study. An analysis will be carried out after 15 patients.
Analysis of the results :
the results of the first and second 24 hour data will be compared (automatically by computer analysis).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gaviscon syrup | Other | Drug: Gaviscon SyrupGaviscon 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 |
Who may qualify
- Ages
- Up to 6 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- children in whom a pH-monitoring was asked
- pre school-age children
- hospitalized children
- parents have the informed consent signed.
Key exclusion criteria (1 listed)
- children over 6 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Gaviscon SyrupAlso: natriumalginaat and natriumbicarbonaat, BE386802. | Drug | Gaviscon syrup |
Primary outcome
Incidence of pathological GERD
Time frame: 24 and 48 hours
change in pathological GERD from baseline at 24 and 48 hours
2 secondary outcomes
Effect of Gaviscon on pain in infants with GERD
Time frame: 24 and 48 hours
Effect of Gaviscon on parental concern for parents of infants with GERD
Time frame: 24 hours and 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gaviscon Syrup in people with Gastroesophageal Reflux, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of pathological GERD (time frame: 24 and 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.