A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s Disease - Tabular View

Tracking Information

First Received Date ^ICMJE

September 22, 2005

Last Updated Date

May 25, 2009

Start Date ^ICMJE

October 2005

Primary Completion Date

February 2006 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To assess the acceptability of Pentasa Sachets in comparison with the reference Pentasa tablets 500mg in children with Cohn's disease.

Original Primary Outcome Measures ^ICMJE

To access the acceptability of Pentasa Sachets in comparison with the reference Pentasa tablets 500mg in children with Cohn's disease.

Change History

Complete list of historical versions of study NCT00225810 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

To compare the safety of both formulations of Pentasa.
To compare the concentration of mesalazine and N-acetylmesalazine in urine and stool during the administration of both formulations of Pentasa.
To compare the PCD activity index at Week 4 and 8 Phase IV Study design: instead of Single Blind use Open Total enrollment: 29 patients.

Original Secondary Outcome Measures ^ICMJE

To compare the safety of both formulations of Pentasa.
To compare the concentration of mesalazine and N-acetylmesalazine in urine and stool during the administration of both formulations of Pentasa.
To compare the PCD activity index at Week 4 and 8 Phase IV Study design: instead of Single Blind use Open Total enrollment: 29 patients Expected completion: May 2007

Descriptive Information

Brief Title ^ICMJE

A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s Disease

Official Title ^ICMJE

Multicentre, Controlled, Randomised, Open, Cross-Over Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tbl. 500 mg in Children With Crohn´s Disease

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 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.

Detailed Description

Study Phase

Phase IV

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Single Blind, Active Control, Crossover Assignment

Condition ^ICMJE

Crohn's Disease

Intervention ^ICMJE

Drug: Crohn's Disease

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

February 2006

Primary Completion Date

February 2006 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Established diagnose of Crohn's disease
Age 8-18 years, both sexes
Weight above 40 kg
Oral maintenance treatment with 5-ASA and any concomitant antinflammatory medication (maintained at the same dose during the study) before inclusion is permitted,
written informed consent obtained (patient and his/her guardian)

Exclusion Criteria:

Patients with a history of allergy to salicylates
Patients with known significant hepatic or renal function abnormalities
Positive enteric pathogens in stool (Salmonella, Shigella, Yersinia, Campylobacter)
Pregnant or lactating women
Patients with a known history of disease, including mental/emotional disorder, that would interfere with their participation in the study,
Patients who participated in another clinical study in the last 3 months,
Patients who are unable to comply with the requirements of the protocol
Patients who are unable to fill in the diary cards

Gender

Both

Ages

8 Years to 18 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Czech Republic

Administrative Information

NCT ID ^ICMJE

NCT00225810

Responsible Party

Hjort, Director, Ferring Pharmaceuticals

Study ID Numbers ^ICMJE

PENT-IBD-CH CZ

Study Sponsor ^ICMJE

Ferring Pharmaceuticals

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

Information Provided By

Ferring Pharmaceuticals

Verification Date

May 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP