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

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

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 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

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




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.



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862121


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

Responsible Party: Ferring Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00862121     History of Changes
Other Study ID Numbers: FE999907 CS05
EudraCT no: 2008-002100-26
First Posted: March 16, 2009    Key Record Dates
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