A Single-Blind, Randomised, Parallel-Group, Single-Centre Pharmacokinetic and pH-Monitoring Study of Esomeprazole in Infants up to 24 Months of Age

• Conditions: Gastroesophageal Reflux Disease; MedDRA version: 14.1Level: LLTClassification code 10018203Term: GERDSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2012-001159-37-Outside-EU/EEA
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-08
• Last Update Posted: 20 March 2012

Recruitment & Eligibility

• Status: A
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Inclusion criteria
For inclusion in the study, subjects had to fulfil all of the following criteria:
1.Age =1 months to =24 months.
2.Able to ingest semisolid food if =3 months of age 3.Symptoms of GERD as judged by the investigator.
4.Failed conservative therapy if =12 months old.
5.Diagnosis confirmed by 24-hour pH-monitoring, the criteria being:
a) =12 months old: reflux index (% time pH <4) of =5%
b) >12 months old: reflux index (% time pH <4) of =5%.
6.Informed consent signed by parent or guardian.

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 was regarded as a criterion for exclusion from the study:
1.Current or historical clinically significant illness that would, as judged by the investigator, be expected to interfere with the study procedures or with the metabolism of esomeprazole, or jeopardise the safety of the subject.
2.Current or previous evidence of liver disease and necrotising enterocolitis.
3.Receipt of experimental drug or use of experimental device within 8 weeks preceeding screening.
4.History of resectional surgery of the esophagus, stomach, duodenum or jejunum.
5.Use of any pharmacological antireflux therapy within 24 hours prior to the first dose of investigational product.
6.Use of any proton pump inhibitor within 72 hours of the first dose of investigational product.
7.Need for continuous concurrent therapy with anticholinergics, antineoplastic agents, H2-receptor antagonists, sucralfate, bismuth-containing compounds, methyl-xanthines (theophylline), pro-motility drugs, macrolide antibiotics or barbiturates.
8.Known hypersensitivity to esomeprazole, substituted benzimidazoles or any other constituents of the formulation (glycerol monostearate 40-55, hydroxypropylcellulose, hypromellose, magnesium stearate, methacrylic acid - ethyl acrylate copolymer (1:1) dispersion 30 per cent, polysorbate 80, sugar spheres, talc, triethyl citrate).
9.Congenital drug addiction.
10.Previous participation in the present study.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Primary objectives<br>To assess the pharmacokinetics of esomeprazole and its efficacy in controlling intragastric pH in infants.<br>;Secondary Objective: Secondary objectives<br>·To assess the efficacy of esomeprazole in controlling esophageal acid exposure<br>·To assess the safety and tolerability of esomeprazole in infants<br>·To assess the ability of esomeprazole to reduce GERD symptoms in infants.<br>;Primary end point(s): The primary PK variables AUCt, AUCt, CSSmax were considered the most relevant to describe the exposure to esomeprazole in the study population.;Timepoint(s) of evaluation of this end point: Last dosing day (day 7 of 7 days dosing)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): The primary PD variable percentage of time with intragastric pH >4 is generally considered a relevant variable because of its close correlation to clinical effect in the treatment of GERD.<br><br>Safety is measured by Adverse Events (AEs), laboratory measurement, weight, height, head circumference, pulse and breathing rate;Timepoint(s) of evaluation of this end point: PD variable measured Last dosing day (day 7 of 7 days dosing). Safety during the course of the study and the day 8, day following last dosing.