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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
San Diego Clinical Trials
San Diego, California, United States
Clinical Research of West Florida
Clearwater, Florida, United States
Atlanta Gastroenterology Specialists
John's Creek, Georgia, United States
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.
Time frame: At Week 10, end of treatment
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Within the 10 week treatment period
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Center for Digestive and Liver Disease, Inc
Mexico, Montana, United States
Wake Research Associates
Raleigh, North Carolina, United States
Consultants for Clinical Research Inc.
Cincinnati, Ohio, United States
Hartwell Research Group, LLC
Anderson, South Carolina, United States
CHC Saint Joseph
Liège, Belgium
Herlev University Hospital
Copenhagen, Denmark
Investigational Site
Lille, France
...and 5 more locations
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.
Time frame: At Week 10, end of treatment