A Phase 2/3 interventional study of Rifaximin delayed released 400mg Tablet and Placebo in Diverticulitis, sponsored by Alfasigma S.p.A.. Terminated at 64 sites in 6 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-10-20.
Sponsored by Alfasigma S.p.A. · Phase 2/3, Interventional, and Prevention
Colonic microbiota changes may play a key role in the pathogenesis of acute diverticulitis. A previous proof-of-concept study suggests that rifaximin, a low-absorbable oral antibiotic, may be beneficial for prevention of acute diverticulitis recurrence by modulating the gut microflora.
The main objective of this study is to evaluate the safety and efficacy of two different doses of a delayed release formulation of rifaximin, versus placebo, for the prevention of recurrence of acute diverticulitis and diverticular complications in patients with a recent episode of acute diverticulitis.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria apply
(i.e. 2 x 400 mg tablet twice a day; total daily dose: 1600 mg) for 10 consecutive days a month, for 12 months
Drug: Rifaximin delayed released 400mg Tablet
(i.e. 1x400 mg tablet plus 1 placebo tablet twice a day; total daily dose: 800 mg) for 10 consecutive days a month, for 12 months
Drug: Rifaximin delayed released 400mg Tablet · Other: Placebo
(i.e. 2 x placebo tablets twice a day) for 10 consecutive days a month, for 12 months.
Other: Placebo
Rifaximin delayed released
Also known as: Rifaximin-EIR
Placebo BID + Placebo BID
Rate of patients with recurrence of diverticulitis and/or diverticular complications over the 12-month treatment period.
Time frame: 12-month treatment period
Rate of patients with an acute episode of prolonged (≥24 hours) left-lower quadrant abdominal pain plus leukocytosis/elevation of CRP [Time Frame: 12-month treatment period]
Time frame: 12-month treatment period
Time to diverticulitis recurrence or complication
Time frame: 12-month treatment period
Rate of patients with diverticulitis-associated fever
Time frame: 12-month treatment period
Left-lower quadrant abdominal pain intensity
Time frame: 12-month treatment period
Left-lower quadrant abdominal pain duration
Time frame: 12-month treatment period
Number of days in a year with left-lower quadrant abdominal pain
Time frame: 12-month treatment period
Number of weeks in a year with episodes of prolonged (≥24 hours) left-lower quadrant abdominal pain
Time frame: 12-month treatment period
Number of days in a year with any abdominal pain
Time frame: 12-month treatment period
Number of weeks in a year with bloating
Time frame: 12-month treatment period
Change in bowel habits
Evaluated by Bristol Stool Scale
Time frame: 12-month treatment period
Rate of any hospitalization for diverticulitis
Time frame: 12-month treatment period
Rate of hospitalization for diverticulitis without surgery
Time frame: 12-month treatment period
Rate of elective surgery for diverticulitis
Time frame: 12-month treatment period
Rate of emergency surgery for diverticulitis
Time frame: 12-month treatment period
Change in Quality of Life
Evaluated by SF36 Quality of Life Questionnaire
Time frame: 12-month treatment period
This study is terminated, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Alfasigma S.p.A.