Gastroesophageal RefluxPhase 3NCT00226044
Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
A Phase 3 study testing Omeprazole rectally 1mg/kg in people with Gastroesophageal Reflux and Esophageal Atresia, run by Rijnstate Hospital at 1 site in Netherlands.
Trial summary
The purpose of this study is to compare the efficacy of oral and rectal omeprazole treatment in infants with gastroesophageal reflux due to esophageal atresia or congenital diaphragmatic hernia. Read more about this study
- Who is it for?
- Ages 6 weeks to 3 months
- Conditions the study is for
- Gastroesophageal Reflux, Esophageal Atresia, Hernia, Diaphragmatic
- What is being tested?
- Omeprazole rectally 1mg/kg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteNetherlands
- Study dates
- Sep 2005to Sep 2017
- Phase
- Phase 3
- 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 6 weeks to 3 months
- All sexes
- No healthy volunteers
- Child
Infants were eligible for the study if they were:
- 6-12 weeks postnatal age
- weighed more than 3 kg
- were after surgical repair for EA or CDH
- showed clinical GERD
- were to undergo the 48 hour pH measurements.
Infants were excluded if they were:
- allergic to omeprazole
- participated in other interventional trials
- used medications known to interact with omeprazole.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Rectal and Oral Omeprazole Treatment of Gastroesophageal Reflux in Infants With Esophageal Atresia or Congenital Diaphragmatic Hernia; A Pharmacodynamic and Pharmacokinetic Study.
The purpose of this study is to compare the efficacy of oral and rectal omeprazole treatment in infants with gastroesophageal reflux due to esophageal atresia or congenital diaphragmatic hernia.
Read the detailed description
Omeprazole is a highly effective drug for the treatment of gastroesophageal reflux disease (GERD) in infants. Infants, aged 0-12 months, require a non-standard dose of omeprazole. Due to this fact extemporaneous formulations of omeprazole are administered to these infants. The oral bioavailability of omeprazole in nonproprietary formulations may be unpredictable and produce variable degrees of drug exposure. The dose range for GERD management in pediatric studies using omeprazole is 0.3 - 3.5 mg/kg/day.
Dosing information, aged-specific pharmacodynamic and pharmacokinetic data are not available in infants, aged 0-12 months. Two adult studies at healthy volunteers suggest that an omeprazole suppository is an effective dosage form.This study is designed to evaluate and to compare the efficacy, the pharmacodynamics and the pharmacokinetics of oral and rectal omeprazole treatment in infants with gastroesophageal reflux disease.
- Being tested
- Omeprazole rectally 1mg/kg
- Keywords
- Omeprazole, suppository, infants
- Medical subject headings
- Gastroesophageal Reflux, Esophageal Atresia, Hernia, Diaphragmatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omeprazole rectally 1mg/kgDrug
A single dose of 1 mg/kg rectally administered omeprazole.
| Study group | Role | What they receive |
|---|---|---|
| Oral omeprazole | No intervention | Standard of care: A single dose of 1 mg/kg orally administered omeprazole. |
| Rectal omeprazole | Active comparator | A single dose of 1 mg/kg rectally administered omeprazole. Receives: Drug: Omeprazole rectally 1mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic efficacy
Primary: percentage of infants for which omeprazole was effective according to predefined criteria for 24 hour intraesophageal pH.
Measured: 24 hour
Secondary outcomes (4)
Intragastric pH
Secondary: outcomes were the percentage of time gastric pH was <3 and <4
Measured: 24 hours
Maximum plasma concentration (Cmax)
The maximal concentration of OME, OH-OME and OME-S in plasma (Cmax)
Measured: 8 hours
Time to reach Cmax (Tmax)
time to reach Cmax (Tmax)
Measured: 8 hours
Area under the curve (AUC)
The AUC from time zero to the last sampling time point (AUC0-t)
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2005 (estimated)
- Study startSep 2005
- Primary completionSep 2016
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal RefluxStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study was an open-label randomized intervention trial to study the efficacy of a single oral or rectal administered omeprazole dose of 1 mg/kg in infants with GERD due to EA or CDH.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- S.N. de Wildt, Prof. Dr., Study director, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00226044
- Sponsor's protocol ID
- LTC-001
- Status last verified
- Oct 2019
- First submitted
- 22 Sep 2005
- Last updated
- 7 Oct 2019
- Results posted
- No
Publications
Bestebreurtje P, de Koning BAE, Roeleveld N, Knibbe CAJ, Tibboel D, van Groen B, van de Ven CP, Plotz FB, de Wildt SN. Rectal Omeprazole in Infants With Gastroesophageal Reflux Disease: A Randomized Pilot Trial. Eur J Drug Metab Pharmacokinet. 2020 Oct;45(5):635-643. doi: 10.1007/s13318-020-00630-8.
PubMed 32594305
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rectal and Oral Omeprazole Treatment of Gastroesophageal Reflux in Infants With Esophageal Atresia or Congenital Diaphragmatic Hernia; A Pharmacodynamic and Pharmacokinetic Study.
- ClinicalTrials.gov ID
- NCT00226044
- Acronym / sponsor ID
- LTC-001
- Keywords
- Omeprazole, suppository, infants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Collaborators
- Erasmus Medical Center
- Study start
- Sep 2005 (actual)
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 26 Sep 2005 (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.
The purpose of this study is to compare the efficacy of oral and rectal omeprazole treatment in infants with gastroesophageal reflux due to esophageal atresia or congenital diaphragmatic hernia.
Detailed description
Omeprazole is a highly effective drug for the treatment of gastroesophageal reflux disease (GERD) in infants. Infants, aged 0-12 months, require a non-standard dose of omeprazole. Due to this fact extemporaneous formulations of omeprazole are administered to these infants. The oral bioavailability of omeprazole in nonproprietary formulations may be unpredictable and produce variable degrees of drug exposure. The dose range for GERD management in pediatric studies using omeprazole is 0.3 - 3.5 mg/kg/day.
Dosing information, aged-specific pharmacodynamic and pharmacokinetic data are not available in infants, aged 0-12 months. Two adult studies at healthy volunteers suggest that an omeprazole suppository is an effective dosage form.This study is designed to evaluate and to compare the efficacy, the pharmacodynamics and the pharmacokinetics of oral and rectal omeprazole treatment in infants with gastroesophageal reflux disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This study was an open-label randomized intervention trial to study the efficacy of a single oral or rectal administered omeprazole dose of 1 mg/kg in infants with GERD due to EA or CDH.
| Arm | Type | Receives |
|---|---|---|
| Oral omeprazole | No intervention | –Standard of care: A single dose of 1 mg/kg orally administered omeprazole. |
| Rectal omeprazole | Active comparator | Drug: Omeprazole rectally 1mg/kgA single dose of 1 mg/kg rectally administered omeprazole. |
Who may qualify
- Ages
- 6 weeks to 3 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
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 |
|---|---|---|
| Omeprazole rectally 1mg/kgA single dose of 1 mg/kg rectally administered omeprazole. | Drug | Rectal omeprazole |
Primary outcome
Therapeutic efficacy
Time frame: 24 hour
Primary: percentage of infants for which omeprazole was effective according to predefined criteria for 24 hour intraesophageal pH.
4 secondary outcomes
Intragastric pH
Time frame: 24 hours
Maximum plasma concentration (Cmax)
Time frame: 8 hours
Time to reach Cmax (Tmax)
Time frame: 8 hours
Area under the curve (AUC)
Time frame: 8 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 7 Oct 2019.
- Derived from this study: PubMed 32594305Bestebreurtje P, de Koning BAE, Roeleveld N, Knibbe CAJ, Tibboel D, van Groen B, van de Ven CP, Plotz FB, de Wildt SN. Rectal Omeprazole in Infants With Gastroesophageal Reflux Disease: A Randomized Pilot Trial. Eur J Drug Metab Pharmacokinet. 2020 Oct;45(5):635-643. doi: 10.1007/s13318-020-00630-8.
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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.
S.N. de Wildt, Prof. Dr. study director
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Omeprazole rectally 1mg/kg in people with Gastroesophageal Reflux and Esophageal Atresia, run by Rijnstate Hospital at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 7 Oct 2019. 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 Netherlands. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Therapeutic efficacy (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00226044, which also lists 1 linked publication.
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 7 Oct 2019.