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.
125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.
This study's enrollment of 193 is above the median of 120 across 63 interventional studies indexed under Diverticulitis.
Browse Diverticulitis studies →Alfasigma S.p.A. is the lead sponsor of 24 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key Exclusion Criteria:
NOTE: Other protocol defined Inclusion/Exclusion criteria apply
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
(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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