Status:
TERMINATED
Rifaximin Delayed Release for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications.
Lead Sponsor:
Alfasigma S.p.A.
Conditions:
Diverticulitis
Eligibility:
All Genders
18-80 years
Phase:
PHASE2
PHASE3
Brief Summary
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 benefici...
Eligibility Criteria
Inclusion
- Key
- Men and women aged 18-80 years at screening.
- Female participants must be either of non-childbearing potential or of childbearing potential with a negative pregnancy test result at screening and randomization AND agreeing to use a highly effective method of contraception.
- A previous documented episode of diverticulitis between 30 and 180 days prior to screening.
- Clinical remission from acute diverticulitis at screening
- Key
Exclusion
- History of two or more acute diverticulitis episodes or history of any diverticular complication.
- Any documented current organic disease of the gastrointestinal tract other than diverticulosis
- Laboratory signs of clinically significant acute inflammation or signs/symptoms of diverticular complications.
- Diagnosis or history of inflammatory bowel disease (or other conditions associated with ulcerative lesions of the intestinal tract).
- Patients with positive Clostridium difficile toxin stool assay.
- Use of marketed rifaximin (or neomycin or other low-absorbable oral antibiotics) during or after the previous episode of acute diverticulitis.
- Severe hepatic impairment
- Severe kidney impairment
- Any other current significant health condition that in the Investigator's judgement may: i) jeopardize the patient's safe participation in the trial or ii) make unlikely the patient's completion of the study or iii) make unlikely the patient's compliance with the study procedures.
- History of hypersensitivity to rifaximin, rifamycin-derivatives or any of the rifaximin delayed release or placebo excipients.
- NOTE: Other protocol defined Inclusion/Exclusion criteria apply
Key Trial Info
Start Date :
July 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 22 2020
Estimated Enrollment :
193 Patients enrolled
Trial Details
Trial ID
NCT03469050
Start Date
July 2 2018
End Date
December 22 2020
Last Update
October 20 2021
Active Locations (64)
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1
Hôpital Avicenne Service Gastro-entérologie
Bobigny, France
2
Cabinet Médical
Lille, France
3
Centre Hospitalier Regional Universitaire Claude Huriez Service de Chirurgie Digestive et Générale
Lille, France
4
Hôpital Saint-Joseph Service Hépato-Gastroentérologie
Marseille, France