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

Crohn's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00225810
• Other study ID #: PENT-IBD-CH CZ
• Status: Completed
• Phase: Phase 4
• First received: September 22, 2005
• Last updated: May 18, 2011
• Start date: October 2005
• Est. completion date: February 2006

Study information

• Verified date: May 2011
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug Control
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: February 2006
• Est. primary completion date: February 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Drug:
• Crohn's Disease

Locations

Country	Name	City	State
Czech Republic	Faculty Hospital Bulovka, Paediatric Clinic	Prague
Czech Republic	Faculty Hospital Motol, Paediatric Clinic	Prague

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Czech Republic, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To assess the acceptability of Pentasa Sachets in comparison with the reference Pentasa tablets 500mg in children with Cohn's disease.
Secondary	To compare the safety of both formulations of Pentasa.
Secondary	To compare the concentration of mesalazine and N-acetylmesalazine in urine and stool during the administration of both formulations of Pentasa.
Secondary	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.