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

Primary Purpose

Crohn´s Disease

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Pentasa
Placebo
Sponsored by
Ferring Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn´s Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • San Diego Clinical Trials
  • Clinical Research of West Florida
  • Atlanta Gastroenterology Specialists
  • Center for Digestive and Liver Disease, Inc
  • Wake Research Associates
  • Consultants for Clinical Research Inc.
  • Hartwell Research Group, LLC
  • CHC Saint Joseph
  • Herlev University Hospital
  • Investigational Site
  • Investigational Site
  • Internist Gastroenterologie, Evangelisches Krankenhaus Kalk Akad. Lehrkrankenhaus für die Universität Köln
  • Gemeinschaftspraxis
  • Lunds Lasaret
  • Addenbrookes Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Mesalazine

Placebo

Arm Description

Mesalazine (Mesalamine) 2 g sachet; 6 g daily

Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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).
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.
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.

Full Information

First Posted
March 13, 2009
Last Updated
March 15, 2012
Sponsor
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00862121
Brief Title
A Study With Pentasa in Patients With Active Crohn's Disease
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to poor recruitment
Study Start Date
April 2009 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ferring Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn´s Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesalazine
Arm Type
Experimental
Arm Description
Mesalazine (Mesalamine) 2 g sachet; 6 g daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
Intervention Type
Drug
Intervention Name(s)
Pentasa
Intervention Description
6 g/day orally, 2 g in the morning and 4 g in the evening
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
6 g/day orally, 2 g in the morning and 4 g in the evening
Primary Outcome Measure Information:
Title
Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10.
Description
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.
Time Frame
At Week 10, end of treatment
Secondary Outcome Measure Information:
Title
Relative Change From Baseline to Week 10 in Fecal Calprotectin
Description
Fecal calprotectin is an inflammatory marker for the gastrointestinal tract. Higher values indicate more serious inflammation.
Time Frame
At Week 10, end of treatment
Title
Relative Change From Baseline to Each Visit in Serum C-reactive Protein (CRP)
Description
Serum CRP is a laboratory measure of acute inflammation. Higher values are worse.
Time Frame
Within the 10 week treatment period
Title
Relative Change From Baseline to Each Visit in Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Description
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).
Time Frame
Within the 10 week treatment period
Title
Relative Change From Baseline to Each Visit in Work Productivity & Activity Impairment Questionnaire (WPAI_CD) Score Item 5 (Work Productivity)
Description
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.
Time Frame
Within the 10 week treatment period
Title
Relative Change From Baseline to Week 10 in Estimated Creatinine Clearance
Description
A lower creatinine clearance indicates worsening of renal function. Creatinine clearance was estimated from serum creatinine levels, using the Cockcroft-Gault formula.
Time Frame
At Week 10, end of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Development Support
Organizational Affiliation
Ferring Pharmaceuticals
Official's Role
Study Director
Facility Information:
Facility Name
San Diego Clinical Trials
City
San Diego
State/Province
California
Country
United States
Facility Name
Clinical Research of West Florida
City
Clearwater
State/Province
Florida
Country
United States
Facility Name
Atlanta Gastroenterology Specialists
City
John's Creek
State/Province
Georgia
Country
United States
Facility Name
Center for Digestive and Liver Disease, Inc
City
Mexico
State/Province
Montana
Country
United States
Facility Name
Wake Research Associates
City
Raleigh
State/Province
North Carolina
Country
United States
Facility Name
Consultants for Clinical Research Inc.
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Hartwell Research Group, LLC
City
Anderson
State/Province
South Carolina
Country
United States
Facility Name
CHC Saint Joseph
City
Liège
Country
Belgium
Facility Name
Herlev University Hospital
City
Copenhagen
Country
Denmark
Facility Name
Investigational Site
City
Lille
Country
France
Facility Name
Investigational Site
City
Berlin
Country
Germany
Facility Name
Internist Gastroenterologie, Evangelisches Krankenhaus Kalk Akad. Lehrkrankenhaus für die Universität Köln
City
Köln
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Leipzig
Country
Germany
Facility Name
Lunds Lasaret
City
Lund
Country
Sweden
Facility Name
Addenbrookes Hospital
City
Cambridge
Country
United Kingdom

12. IPD Sharing Statement

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

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