Gastroesophageal Reflux Disease (GERD)Phase 2OMEPRAZOLE-1NCT01657578
Optimal Dosing of Omeprazole in Neonates
A Phase 2 study testing Omeprazole in people with Gastroesophageal Reflux Disease (GERD), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
"The principal aim of this trial is to determine the minimum effective dose of omeprazole in neonates with GERD objectively diagnosed by a 24-h intra-oesophageal pH monitoring (pHmetry), to obtain a short-term efficacy in the pHmetry of control performed 72 hrs ± 24 after initiation of omeprazole. Read more about this study
- Who is it for?
- Ages 35 weeks and older
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- What is being tested?
- Omeprazole
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2007to Feb 2012
- Phase
- Phase 2
- 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 35 weeks and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Full-term neonates or preterm neonates with a postmenstrual age >/= 35 weeks
- Presenting abnormal pHmetry (= percentage of the entire record that intra-oesophageal pH is <4 is superior or equal to 5%)
- Patient must receive discontinuous oral feedings
- If proton pump inhibitors or other pharmacologic antireflux therapies had already commenced, these had to be withdrawn 7 days before baseline recordings
- In-patient in Neonatal Intensive Care Unit or Neonatology Unit of the Robert Debré University Hospital
- Both parents sign written informed consent form
- Affiliated to social security
Who cannot join
- Patients under proton pump inhibitors (PPI) treatment or that have discontinued PPI treatment less than 7 days before inclusion
- Patients with acute gastrointestinal disease (diarrhoea)
- Patients than present leucopenia or thrombocytopenia (value half the normal value for age)
- Patients that present aspartate and alanine aminotransferase values twice the upper limit of normal
- Patients that present renal and hepatic failure
- Newborns presenting galactosemia, glucose-galactose malabsorption, deficiency in lactase enzymes
- Co-administration of atazanavir and ritonavir
- Patients allergic to omeprazole or to any other ingredients in the medicine
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimal Dose and Population Pharmacokinetics of Omeprazole in Neonates With Gastroesophageal Reflux Disease (GERD)
"The principal aim of this trial is to determine the minimum effective dose of omeprazole in neonates with GERD objectively diagnosed by a 24-h intra-oesophageal pH monitoring (pHmetry), to obtain a short-term efficacy in the pHmetry of control performed 72 hrs ± 24 after initiation of omeprazole.
The secondary objectives of the study were: (1) to assess the efficacy of omeprazole upon other pHmetry parameters, (2) to characterize the population pharmacokinetics and pharmacogenetics of omeprazole, (3) to evaluate the effect of omeprazole upon oro-pharyngeal pH monitoring and (4) to assess the short-term safety of use of omeprazole in neonates."
Read the detailed description
"Omeprazole is a proton pump inhibitor increasingly prescribed in the neonatal population for gastroesophageal reflux disease (GERD) complicated or not by the presence of esophagitis. Although extensively evaluated in adults, optimal dosing schemas, efficacy and safety have not been determined in the neonatal population where its prescription remains off-label. The study is a double blind trial that was designed using a Bayesian sequential analysis approach. The principle of this approach is to identify the adequate drug dosage to obtain a level of efficacy as close as possible to a predetermined target level of efficacy in the population. In this study, five different dosages of omeprazole are tested (1, 1,5, 2, 2,5, 3 mg/kg/day) and a target probability of successful treatment of 95% has been chosen. To assess the influence of gestational age on omeprazole's efficacy, analysis was stratified on 3 groups: (1) neonates of less than 32 weeks gestational age (GA), (2) neonates born between 32 and 35 weeks of GA, (3) neonates of more than 36 weeks of GA.
A total maximum number of 90 neonates is expected to be included (30 neonates per group).
Patients' participation in the study ends after completion of the pHmetry of control that is 72 ±24 hours after omeprazole initiation.
Patients in the study will all benefit for the management of their GERD from non-pharmacological therapies such as adequate positioning and use of available thickening agents for formula The only pharmacologic agent authorised during study for treating GERD is omeprazole. All other available GERD treatments will not be prescribed."
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Being tested
- Omeprazole
- Keywords
- neonates, reflux disease, population pharmacokinetics, omeprazole
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmeprazoleDrug
Also called administration of Omeprazole
administration of Omeprazole
| Study group | Role | What they receive |
|---|---|---|
| neonates of less than 32 weeks gestational age | Experimental | omeprazole Receives: Drug: Omeprazole |
| neonates born between 32 and 35 weeks of GA | Experimental | omeprazole Receives: Drug: Omeprazole |
| neonates of more than 36 weeks of GA | Experimental | omeprazole Receives: Drug: Omeprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a normalised control pHmetry Presence of a normalised control pHmetry Presence of a normalised control pHmetry
Normalised control pHmetry is defined by a reflux index (duration that the recorded intra-oesophageal pH is less than 4.0, expressed as a percentage of the total duration of pH monitoring) of less than 5%
Measured: 72±24 hours after initiation of omeprazole treatment
Secondary outcomes (5)
mean number of reflux episodes per hour
mean number of reflux episodes per hour
Measured: 72±24 hours after initiation of omeprazole treatment
duration of the longest reflux episode
duration of the longest reflux episode
Measured: 72±24 hours after initiation of omeprazole treatment
plasma concentrations of omeprazole and its metabolite, hydroxyl-omeprazole
Plasma concentrations of omeprazole and its metabolite, hydroxyl-omeprazole, After the first administration of omeprazole, blood will be collected either between H0.5 and H4 or between H4 and H12 or both
Measured: H0.5 and H4 or between H4 and H12 after the first administration of omeprazole
changes in salivary pH monitoring
changes in salivary pH monitoring Without treatment period: just before and 3 hours after a meal Under treatment period: just before and just after the insertion of the pHmetry catheter
Measured: just before and 3 hours after a meal Under treatment period
changes in biological parameters
changes in biological parameters
Measured: 96±24 hours after initiation of omeprazole treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2012 (estimated)
- Study startJun 2007
- Primary completionDec 2010
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evelyne Jacqz-Aigrain, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01657578
- Sponsor's protocol ID
- P 051043
- Other IDs
- 2006-005335-16
- Acronym
- OMEPRAZOLE-1
- Status last verified
- Jul 2012
- First submitted
- 2 Aug 2012
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimal Dose and Population Pharmacokinetics of Omeprazole in Neonates With Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT01657578
- Acronym / sponsor ID
- OMEPRAZOLE-1 / P 051043
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- neonates, reflux disease, population pharmacokinetics, omeprazole
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Dec 2010 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 6 Aug 2012 (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 principal aim of this trial is to determine the minimum effective dose of omeprazole in neonates with GERD objectively diagnosed by a 24-h intra-oesophageal pH monitoring (pHmetry), to obtain a short-term efficacy in the pHmetry of control performed 72 hrs ± 24 after initiation of omeprazole.
The secondary objectives of the study were: (1) to assess the efficacy of omeprazole upon other pHmetry parameters, (2) to characterize the population pharmacokinetics and pharmacogenetics of omeprazole, (3) to evaluate the effect of omeprazole upon oro-pharyngeal pH monitoring and (4) to assess the short-term safety of use of omeprazole in neonates."
Detailed description
"Omeprazole is a proton pump inhibitor increasingly prescribed in the neonatal population for gastroesophageal reflux disease (GERD) complicated or not by the presence of esophagitis. Although extensively evaluated in adults, optimal dosing schemas, efficacy and safety have not been determined in the neonatal population where its prescription remains off-label. The study is a double blind trial that was designed using a Bayesian sequential analysis approach. The principle of this approach is to identify the adequate drug dosage to obtain a level of efficacy as close as possible to a predetermined target level of efficacy in the population. In this study, five different dosages of omeprazole are tested (1, 1,5, 2, 2,5, 3 mg/kg/day) and a target probability of successful treatment of 95% has been chosen. To assess the influence of gestational age on omeprazole's efficacy, analysis was stratified on 3 groups: (1) neonates of less than 32 weeks gestational age (GA), (2) neonates born between 32 and 35 weeks of GA, (3) neonates of more than 36 weeks of GA.
A total maximum number of 90 neonates is expected to be included (30 neonates per group).
Patients' participation in the study ends after completion of the pHmetry of control that is 72 ±24 hours after omeprazole initiation.
Patients in the study will all benefit for the management of their GERD from non-pharmacological therapies such as adequate positioning and use of available thickening agents for formula The only pharmacologic agent authorised during study for treating GERD is omeprazole. All other available GERD treatments will not be prescribed."
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| neonates of less than 32 weeks gestational age | Experimental | Drug: Omeprazoleomeprazole |
| neonates born between 32 and 35 weeks of GA | Experimental | Drug: Omeprazoleomeprazole |
| neonates of more than 36 weeks of GA | Experimental | Drug: Omeprazoleomeprazole |
Who may qualify
- Ages
- 35 weeks and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Full-term neonates or preterm neonates with a postmenstrual age >/= 35 weeks
- Presenting abnormal pHmetry (= percentage of the entire record that intra-oesophageal pH is <4 is superior or equal to 5%)
- Patient must receive discontinuous oral feedings
- If proton pump inhibitors or other pharmacologic antireflux therapies had already commenced, these had to be withdrawn 7 days before baseline recordings
- In-patient in Neonatal Intensive Care Unit or Neonatology Unit of the Robert Debré University Hospital
Key exclusion criteria (8 listed)
- Patients under proton pump inhibitors (PPI) treatment or that have discontinued PPI treatment less than 7 days before inclusion
- Patients with acute gastrointestinal disease (diarrhoea)
- Patients than present leucopenia or thrombocytopenia (value half the normal value for age)
- Patients that present aspartate and alanine aminotransferase values twice the upper limit of normal
- Patients that present renal and hepatic failure
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 |
|---|---|---|
| OmeprazoleAlso: administration of Omeprazoleadministration of Omeprazole | Drug | neonates born between 32 and 35 weeks of GA, neonates of less than 32 weeks gestational age, neonates of more than 36 weeks of GA |
Primary outcome
Presence of a normalised control pHmetry Presence of a normalised control pHmetry Presence of a normalised control pHmetry
Time frame: 72±24 hours after initiation of omeprazole treatment
Normalised control pHmetry is defined by a reflux index (duration that the recorded intra-oesophageal pH is less than 4.0, expressed as a percentage of the total duration of pH monitoring) of less than 5%
5 secondary outcomes
mean number of reflux episodes per hour
Time frame: 72±24 hours after initiation of omeprazole treatment
duration of the longest reflux episode
Time frame: 72±24 hours after initiation of omeprazole treatment
plasma concentrations of omeprazole and its metabolite, hydroxyl-omeprazole
Time frame: H0.5 and H4 or between H4 and H12 after the first administration of omeprazole
changes in salivary pH monitoring
Time frame: just before and 3 hours after a meal Under treatment period
changes in biological parameters
Time frame: 96±24 hours after initiation of omeprazole treatment
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 11 Oct 2012.
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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.
Evelyne Jacqz-Aigrain, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Omeprazole in people with Gastroesophageal Reflux Disease (GERD), run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 7 inclusion and 8 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 11 Oct 2012. 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 France. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Presence of a normalised control pHmetry Presence of a normalised control pHmetry Presence of a normalised control pHmetry (time frame: 72±24 hours after initiation of omeprazole treatment). 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 11 Oct 2012.