Phase 1 study of Rabeprazole in neonates with GERD

• Research type

  Research Study

• Full title

  A Pharmacokinetic, Pharmacodynamic and Short-term Safety Study of Single and Multiple Day Doses of Rabeprazole Sodium in Neonates and Pre-term Infants with a Corrected Age of Less than 44 Weeks with a Presumptive Diagnosis of GERD

• IRAS ID

  46100

• Contact name

  Richa Gupta

• Sponsor organisation

  Janssen-Cilag International NV

• Eudract number

  2009-015885-75

• ISRCTN Number

  0

• Clinicaltrials.gov Identifier

  0

• Research summary

  This is an open-label, multi-center, Phase I study of an experimental drug called Rabeprazole that's being tested to see if it may be useful in treating gastroesophageal flu disease (GERD) in infants up to 44 weeks of corrected age (sum of the gestational age and the age since birth). This study will compare the effects of single dose rabeprazole and multiple dose rabeprazole. This study will analyse the short-term safety of the study drug along with the pharmacokinetics (PK) and pharmacodynamics (PD) effects. Pharmacokinetic analyses look at how the drug is absorbed, broken down and extracted by the body. Pharmacodynamic analyses look at how the drug affects the body.

• REC name

  North West - Haydock Research Ethics Committee

• REC reference

  10/H1010/25

• Date of REC Opinion

  2 Jul 2010

• REC opinion

  Further Information Favourable Opinion