A Study With Pentasa in Patients With Active Crohn's Disease
- Registration Number
- NCT00862121
- Lead Sponsor
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 20
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Mesalazine Pentasa Mesalazine (Mesalamine) 2 g sachet; 6 g daily Placebo Placebo Placebo to Mesalazine (Mesalamine) 2 g sachet; 6 g daily
- Primary Outcome Measures
Name Time Method Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 10. 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
Name Time Method Relative Change From Baseline to Week 10 in Fecal Calprotectin At Week 10, end of treatment 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) Within the 10 week treatment period 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 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).
Relative Change From Baseline to Each Visit in Work Productivity & Activity Impairment Questionnaire (WPAI_CD) Score Item 5 (Work Productivity) 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.
Relative Change From Baseline to Week 10 in Estimated Creatinine Clearance 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.
Trial Locations
- Locations (14)
Clinical Research of West Florida
🇺🇸Clearwater, Florida, United States
Center for Digestive and Liver Disease, Inc
🇺🇸Mexico, Montana, United States
Gemeinschaftspraxis
🇩🇪Leipzig, Germany
Investigational Site
🇩🇪Berlin, Germany
Hartwell Research Group, LLC
🇺🇸Anderson, South Carolina, United States
Herlev University Hospital
🇩🇰Copenhagen, Denmark
CHC Saint Joseph
🇧🇪Liège, Belgium
Atlanta Gastroenterology Specialists
🇺🇸John's Creek, Georgia, United States
Lunds Lasaret
🇸🇪Lund, Sweden
Addenbrookes Hospital
🇬🇧Cambridge, United Kingdom
San Diego Clinical Trials
🇺🇸San Diego, California, United States
Consultants for Clinical Research Inc.
🇺🇸Cincinnati, Ohio, United States
Wake Research Associates
🇺🇸Raleigh, North Carolina, United States
Internist Gastroenterologie, Evangelisches Krankenhaus Kalk Akad. Lehrkrankenhaus für die Universität Köln
🇩🇪Köln, Germany