An Open Single-centre Study on the Pharmacokinetics and Pharmacodynamics of Esomeprazole After Once Daily Oral Administration for 7 Days in Preterm Infants and Neonates

• Conditions: Gastraesdophageal Reflux Disease; MedDRA version: 14.1Level: LLTClassification code 10018203Term: GERDSystem Organ Class: 10017947 - Gastrointestinal disorders

• Registration Number: EUCTR2012-001160-29-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: 38

Inclusion Criteria

For inclusion in the study patients must fulfil all of the following criteria:
1.provision of signed informed consent by parent or guardian
2.Gestational age = 32 weeks and < 1 month post-term (term=38 gestational weeks)
3.Symptoms of GERD as judged by the investigator
4.Considered for treatment with an acid inhibiting agent based on symptoms of GERD as judged by the investigator
5.GERD diagnosis confirmed by 24-hour pH-monitoring, the criteria being:
reflux index (% time pH < 4) of = 5%
6.Body weight = 1.8 kg - = 6.5 kg

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

Exclusion Criteria

Exclusion criteria
Any of the following is regarded as a criterion for exclusion from the study:
1.Current or historical clinically significant illness or abnormal screening laboratory values that would, as judged by the investigator, be expected to interfere with the study procedures or with the absorption, distribution, or elimination of esomeprazole, or jeopardise the safety of the patient
2.History of resectional surgery of the esophagus, stomach, duodenum or jejunum
3.Receipt of experimental drug or use of experimental device within 4 weeks preceding screening
4.Use of any pharmacological antireflux therapy within 72 hours prior to the diagnostic baseline pH impedance monitoring. Antacids (eg Mylanta) or food thickeners can be used in the 72 hour period up to one hour prior to the pH impedance monitoring
5.Need for continuous concurrent therapy with anticholinergics, antineoplastic agents, H2-receptor antagonists, sucrulfate, bismuth-containing compounds, pro-motility drugs, macrolide antibiotics or barbiturates
6.Known or suspected 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)
7.Congenital drug addiction
8.Proven/suspected to be infected by Hepatitis B/C or HIV

Study & Design

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