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

Study Overview
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Brief Summary
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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.

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

Conditions
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Crohn´s Disease

Intervention / Treatment
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* Drug: Pentasa
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |