Study of Rabeprazole in infants with GORD 1-11 months old, inclusive.

• Research type

  Research Study

• Full title

  A Pharmacokinetic, Pharmacodynamic and Safety Study of Single and Multiple Doses of Rabeprazole in Pediatric Subjects with GERD 1 to 11 Months Old, Inclusive

• IRAS ID

  41380

• Contact name

  Nick Croft

• Sponsor organisation

  Janssen-Cilag Internationa N.V.

• Eudract number

  2008-000452-27

• ISRCTN Number

  ISRCTN

• Research summary

  This is a multicentre study of rabeprazole in infants aged 1-11 months with a diagnosis of gastro-oesophageal flu disease (GORD). [GORD is known as GERD in the United States.] The study consists of 2 parts. Part 1 is already complete and was used to decide the best doses to study in Part 2. The UK will participate in Part 2 only. The study consists of 3 phases, a pretreatment phase (screening of up to 21 days before the beginning of treatment), a treatment phase, and a posttreatment phase lasting at least 2 weeks after the final drug administration. There are 2 options for the treatment phase. Option 1: single daily doses of rabeprazole for 5 days, with 7 blood samples per day on Days 1 and 5; and Option 2: single daily doses of rabeprazole for up to 14 days (10 days minimum), with fewer blood samples (2 samples per day) on Days 1, 5, and 10. Subjects with a weight of less than 5 kg will only be allowed to enter Option 2. In Part 2 of the study (24 subjects), subjects in both options will be randomised into 2 dose groups (12 subjects per dose group). During the screening phase, medical history and evaluation of symptoms will be recorded. During the treatment phase blood samples will be analysed for rabeprazole levels and the safety and effectiveness of rabeprazole will be assessed using a combination of symptom assessment and routine tests (including ECG, blood and urine analyses). After completion of the treatment phase there will be a post-treatment phase with a final visit at least 14 days after the last dose of study drug. The total study length for each subject is approximately 6 weeks (Option 1), or 7 weeks (Option 2).

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/8

• Date of REC Opinion

  1 Apr 2010

• REC opinion

  Further Information Favourable Opinion