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
590
1.2g SPD476 once daily (QD) orally
2.4g SPD476 QD orally
4.8g SPD476 QD orally
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 Were 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
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QD orally
Dedicated Clinical Research
Litchfield Park, Arizona, United States
Lynn Institute of the Ozarks
Little Rock, Arkansas, United States
Advanced Clinical Research Institute
Anaheim, California, United States
GW Research
Chula Vista, California, United States
Monterey Bay GI Research Institute, Inc
Monterey, California, United States
Rancho Cucamonga C. Trials
Rancho Cucamonga, California, United States
Clinical Trials Research
Roseville, California, United States
Medical Associates Research
San Diego, California, United States
Torrance Clinical Research
Torrance, California, United States
Rocky Mountain Gastroenterology Associates
Thornton, Colorado, United States
...and 111 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