Gastraesdophageal Reflux Disease MedDRA version: 14.1 Level: LLT Classification code 10018203 Term: GERD System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: esomeprazole
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: esomeprazole
CAS Number: 217087-09-7
Other descriptive name: ESOMEPRAZOLE MAGNESIUM
Concentration unit: mg milligram(
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. provision of signed informed consent by parent or guardian 2. Gestational age = 32 weeks and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to assess the pharmacokinetics of esomeprazole and its effect on intragastric pH in preterm infants and neonates. ;Timepoint(s) of evaluation of this end point: All PK variables were assessed on Day7/8 ;Secondary Objective: The secondary objectives were: • to assess the effect of esomeprazole on esophageal acid exposure secondary to gastroesophageal reflux (GER) using 24 hour pH monitoring and intraluminal impedance measurements • to assess the safety and tolerability of esomeprazole in preterm infants and neonates • to assess the ability of esomeprazole to reduce symptoms suggestive of gastroesophageal reflux disease (GERD) in preterm infants and neonates ;Primary end point(s): · Area under the plasma concentration versus time curve within a dosing interval at steady-state (AUCt, in the protocol referred to as AUC, ie, area under the plasma concentration versus time curve) (primary variable) · Apparent clearance, ie, oral clearance (CL/F)· Apparent volume of distribution, ie oral volume of distribution (V/F)· Plasma elimination half-life (t½) · Maximum plasma concentration at steady state (Css,max, in the protocol referred to as Cmax, ie, the maximum plasma concentration) was evaluated · | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Intragastric pH measurement • The percentage of time with intragastric pH>4 during the 24-hour period (primary variable) Safety Adverse events, laboratory variables, blood pressure, pulse, respiratory rate, head circumference, weight and length Efficacy Frequency of GERD symptoms from symptom assessment charts. ;Timepoint(s) of evaluation of this end point: Symptom assessment during the 7 days treatment period and day 7/8. PH measurements day 7/8 Safety during the treatment period and as a 14 days follow-up. | — |
Countries
Australia
Contacts
Public ContactInformation Center
AstraZeneca
Outcome results
None listed