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

NCT00225810 | Completed Phase 4

• 1 other identifier: PENT-IBD-CH CZ
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (3)

• 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.

Interventions

Crohn's Disease DRUG

Eligibility Criteria

• Age: 8 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Established diagnose of Crohn's disease
• Age 8-18 years, both sexes
• Weight above 40 kg
• written informed consent obtained (patient and his/her guardian)

You may not qualify if:

• 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

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (2)

Faculty Hospital Bulovka, Paediatric Clinic

Prague, Czechia

Location

Faculty Hospital Motol, Paediatric Clinic

Prague, Czechia

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 22, 2005
• First Posted: September 26, 2005
• Study Start: October 1, 2005
• Primary Completion: February 1, 2006
• Study Completion: February 1, 2006
• Last Updated: May 19, 2011

Record last verified: 2011-05

Locations

CZ (2)