A Study With Pentasa in Patients With Active Crohn's Disease

Crohn´s Disease Clinical Trial

— PEACE  

Official title:

PENTASA in Active Crohn's Disease: A 10-week, Double-blind, Multi-centre Trial Comparing PENTASA Sachet 6 g/Day (Mesalazine, Mesalamine) With Placebo.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00862121
• Other study ID #: FE999907 CS05
• Secondary ID: EudraCT no: 2008
• Status: Terminated
• Phase: Phase 3
• First received: March 13, 2009
• Last updated: March 15, 2012
• Start date: April 2009
• Est. completion date: October 2010

Study information

• Verified date: March 2012
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsDenmark: Danish Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesSpain: Spanish Agency of MedicinesSweden: Medical Products AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this trial is to demonstrate that Pentasa administered as a 2 g morning dose and a 4 g evening dose is efficacious in active mild to moderate CD.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria (main):

• Age: at least 18 years

• CD symptoms/onset of disease: = 3 months prior to Visit 1

• Ileal, ileo-colonic or colonic non-stricturing/non-penetrating disease

• A confirmed location of CD (by MRI, X-ray (small bowel and/or colon), and/or endoscopy)

• A Harvey-Bradshaw score between 5 and 12

• Males and non-pregnant, non-nursing women

• Mild to moderate active CD, defined by a CDAI score between 180 and 350

• Active inflammatory disease (C-Reactive Protein (CRP) level above or equal to 5 mg/L), or a biopsy verified inflammation, or fecal calprotectin level above or equal to 50 µg/g)

• Estimated creatinine clearance should be above 75 ml/min

Exclusion Criteria (main):

• Any significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the trial, or may influence the results of the trial or the patient's ability to participate in the trial

• CD located to the upper gastrointestinal tract and/or jejunal part of the small intestine, and/or to colon below the left colon flexure and/or isolated proctitis and/or anal disease

• Prior treatment resistance to Pentasa (mesalazine)

• Chronic, dominant arthralgia or rheumatoid arthritis

• Palpable abdominal mass

• Biologics (eg anti-TNF-a) must not be used during the trial or 6 months before Visit 1

• Continuous usage of systemic steroids (excluding budesonide) for 3 months or more within the past year

• Positive pregnancy test

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease
• Crohn´s Disease

Intervention

Drug:
• Pentasa
6 g/day orally, 2 g in the morning and 4 g in the evening
• Placebo
6 g/day orally, 2 g in the morning and 4 g in the evening

Locations

Country	Name	City	State
Belgium	CHC Saint Joseph	Liège
Denmark	Herlev University Hospital	Copenhagen
France	Investigational Site	Lille
Germany	Investigational Site	Berlin
Germany	Internist Gastroenterologie, Evangelisches Krankenhaus Kalk Akad. Lehrkrankenhaus für die Universität Köln	Köln
Germany	Gemeinschaftspraxis	Leipzig
Sweden	Lunds Lasaret	Lund
United Kingdom	Addenbrookes Hospital	Cambridge
United States	Hartwell Research Group, LLC	Anderson	South Carolina
United States	Consultants for Clinical Research Inc.	Cincinnati	Ohio
United States	Clinical Research of West Florida	Clearwater	Florida
United States	Atlanta Gastroenterology Specialists	John's Creek	Georgia
United States	Center for Digestive and Liver Disease, Inc	Mexico	Montana
United States	Wake Research Associates	Raleigh	North Carolina
United States	San Diego Clinical Trials	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  France,  Germany,  Sweden,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10.	The Crohn's Disease Activity Index (CDAI) is a composite score to quantify symptoms of Crohn's disease. It has a range of 0-600; higher scores are worse. A responder is defined as a participant who achieved a reduction in the CDAI score to <150 or a decrease in CDAI score of at least 70.	At Week 10, end of treatment	No
Secondary	Relative Change From Baseline to Week 10 in Fecal Calprotectin	Fecal calprotectin is an inflammatory marker for the gastrointestinal tract. Higher values indicate more serious inflammation.	At Week 10, end of treatment	No
Secondary	Relative Change From Baseline to Each Visit in Serum C-reactive Protein (CRP)	Serum CRP is a laboratory measure of acute inflammation. Higher values are worse.	Within the 10 week treatment period	No
Secondary	Relative Change From Baseline to Each Visit in Inflammatory Bowel Disease Questionnaire (IBDQ) Score	The IBDQ is a measure of the impact of inflammatory bowel disease (IBD) on health-related quality-of-life (HRQL; mood, social activities, daily life, and IBD-related health worries). Higher scores are better; Total IBDQ score can range from 32 (very poor HRQL) to 224 (perfect HRQL).	Within the 10 week treatment period	No
Secondary	Relative Change From Baseline to Each Visit in Work Productivity & Activity Impairment Questionnaire (WPAI_CD) Score Item 5 (Work Productivity)	The WPAI_CD Item 5 measures the impact of Crohn's disease on work productivity (while working). The score is recorded by the patient on a visual analog scale, from 0 to 10. Lower scores are better, while higher scores indicate greater negative effect on work productivity.	Within the 10 week treatment period	No
Secondary	Relative Change From Baseline to Week 10 in Estimated Creatinine Clearance	A lower creatinine clearance indicates worsening of renal function. Creatinine clearance was estimated from serum creatinine levels, using the Cockcroft-Gault formula.	At Week 10, end of treatment	Yes