CompletedPhase 3

Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.

Netherlands17 participantsStarted 2005-09

Plain-language summary

The purpose of this study is to compare the efficacy of oral and rectal omeprazole treatment in infants with gastroesophageal reflux due to esophageal atresia or congenital diaphragmatic hernia.

Who can participate

Age range6 Weeks – 3 Months

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Infants were eligible for the study if they were: * 6-12 weeks postnatal age * weighed more than 3 kg * were after surgical repair for EA or CDH * showed clinical GERD * were to undergo the 48 hour pH measurements. Infants were excluded if they were: * allergic to omeprazole * participated in other interventional trials * used medications known to interact with omeprazole.

What they're measuring

Therapeutic efficacy

Timeframe: 24 hour

Trial details

NCT IDNCT00226044

SponsorRijnstate Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2016-09

View on ClinicalTrials.gov More Gastroesophageal Reflux trials