A Phase III, Multicentre, Randomized, Double-blind Parallel-group Study to Evaluate the Safety and Clinical Outcome of Once Daily Esomeprazole for the Treatment of Gastroesophageal Reflux Disease GERD in Pediatric Patients 1 to 11 Years of Age, Inclusive
- Conditions
- Gastroesophageal Reflux DiseaseMedDRA version: 14.1Level: PTClassification code 10017885Term: Gastrooesophageal reflux diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders
- Registration Number
- EUCTR2004-002370-39-Outside-EU/EEA
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 50
For inclusion in the study, patients (or their parents/guardians when applicable) had to fulfill all of the following criteria;
1.Patients’ parents/guardians must have provided written informed consent prior to the execution of any study-related procedures.
2.Patients who were able to comprehend their involvement in a clinical study, including risks and benefits, (typically =6 years of age) must have had assent documented by study personnel prior to any study-related procedures.
3.Patients were males or females between 1 and 11 years of age, inclusive and must have weighed =8 kg.
4.Patients must have been diagnosed with endoscopically proven GERD by the investigator during the screening period. Patients with a previous (within 2 weeks prior to Visit 1) diagnosis of EE by endoscopy and who were candidates for PPI therapy were not required to have an additional endoscopy at baseline (Visit 1). The established endoscopic evidence was accepted only if there was adequate documentation (ie, complete endoscopic reports, photo documentation). Patients with extraesophageal and/or atypical symptoms (ie, failure to thrive, reactive airway disease, etc.) who were candidates for endoscopy qualified for inclusion provided they had endoscopic signs of GERD.
5.Patients who, in the judgment of the investigator, would be considered for treatment with a PPI based on symptoms of pathological GER.
6.Postmenarchal females must have had a negative urine pregnancy test at the time of the screening visit.
Are the trial subjects under 18? yes
Number of subjects for this age range: 26
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
Any of the following was regarded as a criterion for exclusion from the study:
1.Patients who had used a PPI within 7 days prior to randomization (Day 0), including over-the-counter (OTC) omeprazole.
2.Patients who had used any prescription or OTC treatment (other than PPIs) for symptoms of GERD, such as H2RAs or prokinetics, within 72 hours prior to randomization (Day 0). Antacids could have been used, except for those containing bismuth (eg, PEPTO BISMOL® [Procter&Gamble, Cincinnati OH, USA] and Kaopectate® [Pfizer Consumer Healthcare, Morris Plains NJ, USA]).
3.Patients who had a history or current need for resectional or reconstructive surgery of the GI tract (eg, esophagus, stomach, duodenum, jejunum, or colon).
4.Female patients who were taking hormonal contraceptives for medical reasons.
5.Patients who needed to remain on any of the following concomitant medications during the course of the study: bismuth-containing products, barbiturates, anticonvulsants, anticoagulants, narcotics, antineoplastic agents, H2RAs, sucralfate, anti-emetics, systemic steroids (oral and intravenous), pro-motility drugs (eg, cisapride, metoclopramide, domperidone) or macrolide antibiotics such as erythromycin. Use of topical erythromycin was permissible. Occasional doses of nonsteroidal anti-inflammatory drugs (NSAIDs) or salicylates (=3 days) to treat acute conditions were permissible.
6.Patients who had the following diseases/conditions: active gastrointestinal bleed, active peptic ulcer disease, eosinophilic gastroenteritis, allergic gastroenteropathies, inflammatory bowel disease, bleeding disorders, seizure disorders, acute pancreatitis, metabolic diseases or meningitis. Patients who had a past history (prior to study enrollment) of EE, Duodenal Ulcers (DU), Gastric Ulcers (GU) and/or H. pylori infection were eligible for this study if they satisfied other inclusion/exclusion criteria.
7.Patients with H. pylori infection were evaluated on a case-by-case basis. Absolute exclusions were those children with active gastric or duodenal ulceration associated with H. pylori. If there was no documentation of active ulceration or recent GI bleed, the principal investigator (PI) could have, at their discretion, planned for their anti-Helicobacter antibiotic course after this study was completed, provided the patient’s parents/guardian agreed with the course of treatment.
8.The patient’s endoscopic findings had evidence of advanced esophageal lesions due to GERD or other severe upper GI tract pathology (eg, Barrett’s, stricture, neoplasm).
9.Patients who had other major clinical pathology or developmental abnormalities (eg, including but not limited to esophageal atresia, pyloric stenosis), which might have caused gastrointestinal dysmotility as a secondary manifestation.
10.Patients who had acute respiratory distress within 72 hours prior to randomization (Day 0). These patients were eligible for re-evaluation for inclusion once acute symptoms had subsided.
11.Patients who had abnormal screening laboratory values were excluded when the investigator and/or AstraZeneca determined the abnormalities to be unexplained or clinically significant in a way that would put the patient at risk during study participation.
12.Patients who had any condition that might require major surgery during the course of the study.
13.Patients who had a known hypersensitivity, allergy, or intolerance to any com
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method