This prospective study will evaluate the efficacy and safety of esomeprazole for the treatment of GERD in neonatal patients. MedDRA version: 8.1 Level: LLT Classification code 10017885 Term: Gastrooesophageal reflux disease
Conditions
Interventions
Product Name: Esomeprazole (oral solution)
Product Code: NA
Pharmaceutical Form: Oral solution
INN or Proposed INN: esomeprazole sodium
CAS Number: 161796-78-7
Current Sponsor code: NA
Other descripti
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study, patients must fulfil all of the following criteria: 1. Patients’ parent/guardian must provide written informed consent prior to the execution of any study-related procedures. 2. Patients must be full term or have gestational age or post-conceptional age = 28 to 44 weeks (calculated from last menstruations or ultrasound). Patients that are less than 28 weeks gestation may be considered for the study if they fulfill all other criteria, in particular criteria #5. 3. Patient must be an inpatient in the Neonatal Intensive Care Unit (NICU), special care nursery, or equivalent hospital ward at the point of study entry and will be expected to remain an inpatient for the treatment period of the study. If the patient is discharged prior to completion of the treatment phase, parents may be given the option of having at home visits for study drug administration to their baby at the discretion of the investigator. These patients will need to be readmitted to the hospital or, if applicable, brought back to a day clinic for final study day procedures. A treatment period of less than 10 days (minimum 7 days) may be allowed, on a case-by-case basis, with prior approval from the sponsor, provided the patient is considered to be medically stable and considered for discharge from the hospital. 4. Patients must be suspected of having the following clinical findings: any two (either individually or in any combination) of (1) apnea +/- bradycardia +/- oxygen desaturations, (2) vomiting/gagging, (3) irritability/pain at least every second feed or at least twice every eight hours so as to be reproducible on video. Any symptom(s) of GERD that are present for at least 5 days or increasing in frequency or severity over 3 days will make a patient eligible. At least 2 of the occurrences of the above should be reproducible during the 8 hour video. Patients with clinically suspected GERD, based on parental reports or nursing observations may, at the discretion of the investigator, be eligible for enrollment if they fulfill the above criterion regarding the presence of the clinical findings. 5. Patient’s size and medical condition must allow for performance of all study related procedures and administration of investigational product as judged by the investigator. 6. Patients must, ideally, be on a stable mode of feeding or with minimal variations in feeding as judged by the investigator for at least 2 days prior to randomization. If a patient needs a change in feeds for a medical reason, the sponsor must be notified to determine if the patient remains eligible for the study or should be withdrawn. Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Any of the following is regarded as a criterion for exclusion from the study: 1. Patients who exhibit total resolution of all signs and symptoms of GERD during the initial 8 hour video assessment. 2. Use of any pharmacological antireflux therapy (other than study drug) within 72 hours prior to any pH/impedance monitoring. Antacids may be used if it is required during the study as “rescue therapy”, but are not allowed to be taken ± 1 hour to administration of the investigational product and also not 4 hours before and throughout the pH-impedance monitoring at baseline and the final study day. 3. Patients with a history or a current need for resectional or reconstructive surgery of the gastrointestinal tract (esophagus, stomach, duodenum or jejunum). 4. Patients with any condition that may require surgery during the course of the study. Once a patient is enrolled, if a medical condition develops or a pre-existing condition worsens necessitating surgery, then the patient will be allowed to remain in the study provided that there are no additional safety concerns. 5. Patients who must remain on any of the following concomitant medications during the course of the study: bismuth-containing products, barbiturates, anti-convulsants, warfarin, narcotics, antineoplastic agents, H2 receptor antagonists, sucralfate, anti-emetics, pro-motility drugs (eg, cisapride, metoclopramide, macrolide antibiotics such as erythromycin). Use of topical erythromycin is permissible. However, occasional use of restricted medications, when medically indicated after enrollment, is permissible at the discretion of the investigator. If any restricted medication is used, the name of the medication and the reason for taking it should be recorded on the eCRF. 6. Patients with the following diseases/conditions: active gastrointestinal bleed, allergic gastroenteropathies, eosinophilic gastroenteritis, bleeding disorders, active seizure disorder, on-going treatment for seizure disorder, acute pancreatitis or meningitis. 7. Patients with acute respiratory distress within 24 hours prior to enrollment or the likelihood of acute or worsening respiratory distress during the course of the study. A patient may be reconsidered for enrollment once stabilized. Patients with a chronic lung condition, suspected of having GERD as a contributor and who are candidates for acid-suppression therapy are eligible for the study. 8. Patients who are febrile per NICU standards on the day of randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms of GERD as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.;Secondary Objective: The secondary objectives of this study are: · to assess the difference between esomeprazole and placebo in the treatment of symptomatic reflux episodes of GERD. · to assess the difference between esomeprazole and placebo in the treatment of other GERD-related signs and symptoms via video, pH/impedance, and cardiorespiratory monitoring · to assess the efficacy of esomeprazole, compared to placebo, in reducing the number of (a) all types of reflux episodes (acid or non-acid) and (b) acidic reflux episodes, defined as pH < 4, via pH/impedance monitoring · to assess the safety and tolerability of esomeprazole compared to placebo ;Primary end point(s): Primary: change from baseline in the number of occurrences of symptoms of GERD, as observed from video recording, and GERD-related signs detected from cardiorespiratory monitoring | — |
Countries
Germany, United Kingdom
Outcome results
None listed