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

Sponsor:	Ferring Pharmaceuticals
Information provided by:	Ferring Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00225810

Purpose

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.

Condition	Intervention	Phase
Crohn's Disease	Drug: Crohn's Disease	Phase IV

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Crossover Assignment
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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Bowel Movement Crohn's Disease Urine and Urination

Drug Information available for: Mesalamine

U.S. FDA Resources

Further study details as provided by Ferring Pharmaceuticals:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Enrollment:	50
Study Start Date:	October 2005
Study Completion Date:	February 2006
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	8 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00225810

Locations

Czech Republic
Faculty Hospital Motol, Paediatric Clinic
Prague, Czech Republic
Faculty Hospital Bulovka, Paediatric Clinic
Prague, Czech Republic

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

Study Director:

Clinical Development Support

Ferring Pharmaceuticals

More Information

No publications provided

Responsible Party:	Ferring Pharmaceuticals ( Hjort, Director )
Study ID Numbers:	PENT-IBD-CH CZ
Study First Received:	September 22, 2005
Last Updated:	May 25, 2009
ClinicalTrials.gov Identifier:	NCT00225810 History of Changes
Health Authority:	Czech Republic: State Institute for Drug Control

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Gastrointestinal Diseases
Mesalamine
Physiological Effects of Drugs
Inflammatory Bowel Diseases
Intestinal Diseases
Pharmacologic Actions
Digestive System Diseases
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Crohn Disease
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Gastroenteritis
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009