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Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients

2. desember 2010 oppdatert av: AstraZeneca

A Randomized, Double-blind, Placebo Controlled, Study to Evaluate the Efficacy and Safety of Esomeprazole Once Daily for the Treatment of Gastroesophageal Reflux Disease (GERD) in Neonatal Patients, Including Premature and up to 1 Month Corrected Age

The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.

Studieoversikt

Status

Fullført

Forhold

GERD

Intervensjon / Behandling

Legemiddel: Esomeprazol

Studietype

Intervensjonell

Registrering (Faktiske)

Fase

Fase 3

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

Australia
- - North Adelaide, Australia
    - Research Site
Storbritannia
- - Sheffield, Storbritannia
    - Research Site
Tyskland
- - Aachen, Tyskland
    - Research Site

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

Ikke eldre enn 1 måned (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

Full-term or gestational age >/= 28 to 44 weeks
In-patient in Neonatal Intensive Care Unit, special care nursery, or equivalent
Patient must be on a stable mode of feeding or with minimal variations for at least 2 days prior to randomization

Exclusion Criteria:

Patients with a need for resectional or reconstructive surgery of the gastrointestinal tract
Patients with any condition that may require surgery during the course of the study
Patients with acute respiratory distress within 72 hours prior to enrollment

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Primært formål: Behandling
Tildeling: Randomisert
Intervensjonsmodell: Parallell tildeling
Masking: Dobbelt

Hva måler studien?

Primære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Change From Baseline in Normalized Number of GERD Events Observed From Video and Cardiorespiratory Monitoring Tidsramme: Baseline and end of treatment (10-14 days)	The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.	Baseline and end of treatment (10-14 days)

Sekundære resultatmål

Resultatmål	Tiltaksbeskrivelse	Tidsramme
Change From Baseline in Normalized Number of GERD Events During Video and Cardiorespiratory Monitoring Associated With Acid Reflux Tidsramme: Baseline and end of treatment (10-14 days)	Event considered associated with reflux if start time of GERD sign/symptom is within 2 minutes of start time of acid reflux. The number of events are normalized prior to summary to correspond to a complete 8-hour monitoring period. Only patients with data at both baseline and final assessment are included.	Baseline and end of treatment (10-14 days)
Change From Baseline in Number of Reflux Episodes (Acid or Non-acid) Tidsramme: Baseline and end of treatment (10-14 days)	Number of reflux episodes based on 24-hour impedance monitoring data	Baseline and end of treatment (10-14 days)
Change From Baseline in Number of Acidic Reflux Episodes Tidsramme: Baseline and end of treatment (10-14 days)	Number of reflux episodes (pH<4.0) based on 24-hour impedance monitoring data	Baseline and end of treatment (10-14 days)
Change From Baseline in Number of Weakly Acidic Reflux Episodes Tidsramme: Baseline and end of treatment (10-14 days)	Number of reflux episodes (pH 4.0-6.9) based on 24-hour impedance monitoring data	Baseline and end of treatment (10-14 days)
Change From Baseline in Number of Non Acidic Reflux Episodes Tidsramme: Baseline and end of treatment (10-14 days)	Number of reflux episodes (pH>=7.0) based on 24-hour impedance monitoring data	Baseline and end of treatment (10-14 days)
Change From Baseline in Number of Liquid Acidic Reflux Episodes Tidsramme: Baseline and end of treatment (10-14 days)	Number of reflux episodes based on 24-hour impedance monitoring data	Baseline and end of treatment (10-14 days)
Change From Baseline in Number of Mixed Gas/Liquid Acidic Reflux Episodes Tidsramme: Baseline and end of treatment (10-14 days)	Number of reflux episodes based on 24-hour impedance monitoring data	Baseline and end of treatment (10-14 days)
Change From Baseline in Mean Bolus Clearance Time Tidsramme: Baseline and end of treatment (10-14 days)	Based on 24-hour impedance monitoring data	Baseline and end of treatment (10-14 days)
Change From Baseline in Mean Acid Clearance Time Tidsramme: Baseline and end of treatment (10-14 days)	Based on 24-hour impedance monitoring data	Baseline and end of treatment (10-14 days)
Change From Baseline in Percentage Time With pH<4.0 Tidsramme: Baseline and end of treatment (10-14 days)	Percentage time with pH<4 during 24-hour pH monitoring	Baseline and end of treatment (10-14 days)
Change From Baseline in Percentage Time With pH Within 4.0-6.9 Tidsramme: Baseline and end of treatment (10-14 days)	Percentage time with pH 4.0-6.9 during 24-hour pH monitoring	Baseline and end of treatment (10-14 days)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

AstraZeneca

Etterforskere

Studieleder: Per Lundborg, MD, AstraZeneca
Studieleder: Marta Illueca, MD, AstraZeneca
Studieleder: Kathryn Collison, MPH, MT(ASCP), AstraZeneca

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Davidson G, Wenzl TG, Thomson M, Omari T, Barker P, Lundborg P, Illueca M. Efficacy and safety of once-daily esomeprazole for the treatment of gastroesophageal reflux disease in neonatal patients. J Pediatr. 2013 Sep;163(3):692-8.e1-2. doi: 10.1016/j.jpeds.2013.05.007. Epub 2013 Jun 22.

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. oktober 2006

Studiet fullført (Faktiske)

1. april 2009

Datoer for studieregistrering

Først innsendt

25. januar 2007

Først innsendt som oppfylte QC-kriteriene