A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s Disease
Status:
Completed
Trial end date:
2006-02-01
Target enrollment:
Participant gender:
Summary
The primary objective of the clinical trial is the assessment of the acceptability of the new
Pentasa formulation - PentasaR Sachets in comparison with the reference PentasaR tablets 500
mg in children with Crohn's disease. After the screening period (which includes medical
history, physical examination, basic haematology, serum chemistry , urine analysis and stool
microbiology , PCD Activity Index )patients will receive (visit I) Pentasa sachets 1g or
Pentasa tablets 500mg for next 4 weeks according to the randomisation scheme in common dose
2× 1 g of PentasaR Sachets 1 g or PentasaR tablets 500 mg. The formulation of Pentasa will be
switched at Visit 2, patients will receive the medication for next 4 weeks. Patients will
record the acceptability of the both forms of the medication.
In 6 patients from each group (selected by the randomization), stool and urine will be taken
to assess concentrations of mesalazine and N-acetylmesalazine during Visit 2 and Visit 3.
Adverse events will be recorded during the whole course of the treatment period.