Dettagli per singolo studio

DEC-NET Serial number IT392

Published online	15/04/2005 11.03.00
Last updated	02/09/2005 12.21.06

Other protocol ID number	D9614C00098
Current trial status	Planned (i.e. not yet recruiting participants)
Major Disease (ICD9 class)	ESOPHAGEAL REFLUX
Experimental drug
Esomeprazole Treatment regimen (dosage and duration) N/A
Gender	Both
Age (range)	12-17 years
Eligibility criteria
Inclusion criteria
- Signed information sheet and informed consent form - Females of reproductive age should not be sexually active or should be on contraceptives throughout the duration of the study
Exclusion criteria
- Patients must not have taken a proton pump inhibitor drug in the 14 days prior to randomization. - Patients must not have taken an H2 agonist in the 3 days prior to randomization - Patients with acute or chronic diseases that may interefere in the study or influence the study.s outcome, based on the investigator.s judgement - Patients with gastric or duodenal ulcers associated with H.Pylori - Patients hypersensitive, allergic or intollerant to esomeprazole or omeprazole
Trial design/methodology
Phase	3
Kind of study	Efficacy Safety
Design	Controlled Randomised Blinded Double blind Gruppi paralleli
Purpose of study
To evaluate the safety and tollerability of esomeprazole once daily in children and adolescents from 12 to 17 years old for gastroesophageal reflux disease. To evaluate the clinical efficacy of esomeprazole therapy in terms of improvement of signs and symptoms related to GERD. To evaluate the impact of GERD on the quality of life in reflux and dispepsia through the use of a questionnaire.




Summary of study design, objectives, and ongoing research findings
A phase III, multicentre, randomized, double-blind, parallel-group study to evaluate the safety of once daily esomeprazole for the treatment of clinically diagnosed gastroesophageal reflux disease (GERD) in pediatric patients 12 to 17 years of age. About 140 male and female patients, aged 12 - 17 years old and with clinically diagnosed GERD, will be enrolled, in order to end up with a miminum of 108 patients. Patients will be given esomeprazole 20 or 40 mg once daily for 8 weeks. During the 8 week treatment period, patients will fill out a diary daily reporting their symptoms. A telephone follow-up will be performed to evalyate the drug.s safety 14 days after the last drug administration. Adverse events will be taken into consideration, as will lab tests and results of patients. visits.