Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00225810
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2005-09-22
Brief Title:
A Study Comparing the Acceptability of Pentasa Sachets Versus Pentasa Tablets in Children With Crohns Disease
Sponsor:
Ferring Pharmaceuticals
Organization:
Ferring Pharmaceuticals
Study Overview
Official Title:
Multicentre Controlled Randomised Open Cross-over Study Comparing the Acceptability of Pentasa Sachets Versus Pentasa Tbl 500 mg in Children With Crohns Disease
Status:
COMPLETED
Status Verified Date:
2011-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Crohns 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None