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

• ClinicalTrials.gov Identifier: NCT00862121
• Recruitment Status: Terminated
• First Posted: March 16, 2009
• Results First Posted: March 12, 2012
• Last Update Posted: March 16, 2012
• Sponsor: Ferring Pharmaceuticals
• Information provided by (Responsible Party): Ferring Pharmaceuticals

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Crohn´s Disease	Drug: Pentasa; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 20 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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.
• Study Start Date: April 2009
• Actual Primary Completion Date: October 2010
• Actual Study Completion Date: October 2010

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10. [ Time Frame: At Week 10, end of treatment ]
   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.

Secondary Outcome Measures :

1. Relative Change From Baseline to Week 10 in Fecal Calprotectin [ Time Frame: At Week 10, end of treatment ]
   Fecal calprotectin is an inflammatory marker for the gastrointestinal tract. Higher values indicate more serious inflammation.
2. Relative Change From Baseline to Each Visit in Serum C-reactive Protein (CRP) [ Time Frame: Within the 10 week treatment period ]
   Serum CRP is a laboratory measure of acute inflammation. Higher values are worse.
3. Relative Change From Baseline to Each Visit in Inflammatory Bowel Disease Questionnaire (IBDQ) Score [ Time Frame: Within the 10 week treatment period ]
   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).
4. Relative Change From Baseline to Each Visit in Work Productivity & Activity Impairment Questionnaire (WPAI_CD) Score Item 5 (Work Productivity) [ Time Frame: Within the 10 week treatment period ]
   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.
5. Relative Change From Baseline to Week 10 in Estimated Creatinine Clearance [ Time Frame: At Week 10, end of treatment ]
   A lower creatinine clearance indicates worsening of renal function. Creatinine clearance was estimated from serum creatinine levels, using the Cockcroft-Gault formula.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, California

San Diego Clinical Trials

San Diego, California, United States

United States, Florida

Clinical Research of West Florida

Clearwater, Florida, United States

United States, Georgia

Atlanta Gastroenterology Specialists

John's Creek, Georgia, United States

United States, Montana

Center for Digestive and Liver Disease, Inc

Mexico, Montana, United States

United States, North Carolina

Wake Research Associates

Raleigh, North Carolina, United States

United States, Ohio

Consultants for Clinical Research Inc.

Cincinnati, Ohio, United States

United States, South Carolina

Hartwell Research Group, LLC

Anderson, South Carolina, United States

Belgium

CHC Saint Joseph

Liège, Belgium

Denmark

Herlev University Hospital

Copenhagen, Denmark

France

Investigational Site

Lille, France

Germany

Investigational Site

Berlin, Germany

Internist Gastroenterologie, Evangelisches Krankenhaus Kalk Akad. Lehrkrankenhaus für die Universität Köln

Köln, Germany

Gemeinschaftspraxis

Leipzig, Germany

Sweden

Lunds Lasaret

Lund, Sweden

United Kingdom

Addenbrookes Hospital

Cambridge, United Kingdom

Sponsors and Collaborators

Ferring Pharmaceuticals

Investigators

• Study Director: Clinical Development Support; Ferring Pharmaceuticals

More Information

• Responsible Party: Ferring Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT00862121
• Other Study ID Numbers: FE999907 CS05; EudraCT no: 2008-002100-26
• First Posted: March 16, 2009
• Results First Posted: March 12, 2012
• Last Update Posted: March 16, 2012
• Last Verified: March 2012

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Mesalamine; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antirheumatic Agents