A Study With Pentasa in Patients With Active Crohn's Disease (PEACE)

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

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.

Study Overview

• Status: Terminated
• Conditions: Crohn´s Disease
• Intervention / Treatment: Drug: Pentasa; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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-α) 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mesalazine; Mesalazine (Mesalamine) 2 g sachet; 6 g daily	Drug: Pentasa; 6 g/day orally, 2 g in the morning and 4 g in the evening
Placebo Comparator: Placebo; Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily	Drug: Placebo; 6 g/day orally, 2 g in the morning and 4 g in the evening

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Ferring Pharmaceuticals

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: March 13, 2009
• First Submitted That Met QC Criteria: March 13, 2009
• First Posted (Estimate): March 16, 2009

Study Record Updates

• Last Update Posted (Estimate): March 16, 2012
• Last Update Submitted That Met QC Criteria: March 15, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Mesalamine
• Other Study ID Numbers: FE999907 CS05; EudraCT no: 2008-002100-26