The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
592
SPD476 1.2g administered Once Daily (QD)
SPD476 2.4g administered Once Daily (QD)
SPD476 4.8g administered Once Daily (QD)
Percent of Subjects Without Recurrence of Diverticulitis
Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (\>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.
Time frame: up to 104 Weeks
Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis
CT-recurrence of diverticulitis is defined as: a positive spiral CT scan for diverticulitis showing, at a minimum, fat stranding with or without bowel wall thickening \>5 mm or surgical intervention for diverticular disease. Withdrawals considered as CT-recurrences.
Time frame: up to 104 weeks
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive
A positive CT scan was defined as a CT scan that showed bowel wall thickening (\>5 mm) and/or fat stranding as read by the central reader.
Time frame: up to 104 Weeks
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative
A negative CT scan was defined as a CT scan that did not show bowel wall thickening (\>5 mm) and/or fat stranding as read by the central reader.
Time frame: up to 104 weeks
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive
A positive CT scan was defined as a CT scan that showed bowel wall thickening (\>5 mm) and/or fat stranding as read by the central reader.
Time frame: up to 104 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Placebo administered Once Daily (QD)
Birmingham Gastroenterology Associates, PC
Birmingham, Alabama, United States
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, United States
Medical Affiliated Research Center, Inc
Huntsville, Alabama, United States
Alabama Digestive Disorders Center, PC
Huntsville, Alabama, United States
Genova Clinical Research
Tucson, Arizona, United States
Digestive and Liver Disease Specialists
Garden Grove, California, United States
High Desert Gastroenterology, Inc.
Lancaster, California, United States
VA Long Beach Healthcare System
Long Beach, California, United States
CA Physicians Research Alliance
Oceanside, California, United States
Digestive Care Medical Center
San Carlos, California, United States
...and 121 more locations
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative
A negative CT scan was defined as a CT scan that did not show bowel wall thickening (\>5 mm) and/or fat stranding as read by the central reader.
Time frame: up to 104 weeks
Percent of Subjects Requiring Surgery for Diverticulitis
Time frame: up to 104 Weeks