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SPD476-313
Title: A phase III, randomized, double
blind, stratified placebo-controlled study evaluating the
safety and efficacy of SPD476 versus placebo over 104 weeks
in the prevention of the recurrence of Diverticulitis
Diagnosis: Diverticulitis
Primary Objective: To compare the
recurrence of Diverticulitis between the 3 doses of SPD476
and their ability to prevent the recurrence of Diverticulitis.
Eligibility: In order to participate
in the study the patient must meet the eligibility criteria:
1.
Males and females over the age of 18 years.
2.
Female who is able to conceive children are required
to have a negative pregnancy test
3.
At least 1 documented attack of
Diverticulitis within
the past 24 months that has been resolved not by surgical
resection. (Documentation includes CT scan, MRI, barium
enema, ultrasound, or Endoscopy of the sigmoid colon).
4.
White blood cell (WBC) count and polymorphonuclear
leukocyte (PMN) lab work must be within the normal ranges
(will be evaluated at site).
Treatment: Patients who agree to
participate in the study must sign a consent form. Each
patient will be randomized to the 1 of 4 study arms:
Arm A: SPD476 1.2g will be
administered daily for 104 weeks
Arm B: SPD476 2.5g will be
administered daily for 104 weeks
Arm C: SPD476 4.89g will be
administered daily for 104 weeks
Arm D: Placebo 4 tablets
will be administered daily for 104 weeks
*All participants will receive the
placebo to ensure that each patient is taking 4 tablets per
day.*
Low Risk Patients: Arm D is
observational
**All participants will be reimbursed
for the travel and daily expenses for each study visit that
is completed.**
If interested, please
contact Jennifer Hudgins
410-494-1846 x134 or
jhudgins@gastro-doc.com
Or fill out the
Application to Participate
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