Rifaximin Delayed Release for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications.
- Conditions
- Diverticulitis
- Interventions
- Other: Placebo
- Registration Number
- NCT03469050
- Lead Sponsor
- Alfasigma S.p.A.
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 193
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Rifaximin delayed released 400 mg b.i.d 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 Rifaximin delayed released 400 mg b.i.d Placebo (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 Placebo b.i.d. Placebo (i.e. 2 x placebo tablets twice a day) for 10 consecutive days a month, for 12 months. Rifaximin delayed released 800 mg b.i.d. Rifaximin delayed released 400mg Tablet (i.e. 2 x 400 mg tablet twice a day; total daily dose: 1600 mg) for 10 consecutive days a month, for 12 months
- Primary Outcome Measures
Name Time Method Rate of patients with recurrence of diverticulitis and/or diverticular complications over the 12-month treatment period. 12-month treatment period
- Secondary Outcome Measures
Name Time Method Number of weeks in a year with bloating 12-month treatment period Change in bowel habits 12-month treatment period Evaluated by Bristol Stool Scale
Rate of any hospitalization for diverticulitis 12-month treatment period Rate of hospitalization for diverticulitis without surgery 12-month treatment period Rate of elective surgery for diverticulitis 12-month treatment period Rate of emergency surgery for diverticulitis 12-month treatment period Change in Quality of Life 12-month treatment period Evaluated by SF36 Quality of Life Questionnaire
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] 12-month treatment period Time to diverticulitis recurrence or complication 12-month treatment period Rate of patients with diverticulitis-associated fever 12-month treatment period Left-lower quadrant abdominal pain intensity 12-month treatment period Left-lower quadrant abdominal pain duration 12-month treatment period Number of days in a year with left-lower quadrant abdominal pain 12-month treatment period Number of weeks in a year with episodes of prolonged (≥24 hours) left-lower quadrant abdominal pain 12-month treatment period Number of days in a year with any abdominal pain 12-month treatment period
Trial Locations
- Locations (64)
AOU Cagliari - Policlinico Monserrato Gastroenterologia
🇮🇹Cagliari, Italy
Medamed GmbH Studienambulanz Leipzig
🇩🇪Leipzig, Germany
Centre Hospitalier Regional Universitaire Claude Huriez Service de Chirurgie Digestive et Générale
🇫🇷Lille, France
Gemeinschaftspraxis - Praxis Überruhr
🇩🇪Essen, Germany
Ospedale Valduce Unità Operativa Complessa di Gastroenterologia
🇮🇹Como, Italy
Ospedale San Gerardo Endoscopia Digestiva
🇮🇹Monza, Italy
Praxis Dres. med. Naudts und Nowack
🇩🇪Rodgau, Germany
Hôpital Avicenne Service Gastro-entérologie
🇫🇷Bobigny, France
Hôpital Charles Nicolle - CHU Rouen Service Hépato-Gastroentérologie
🇫🇷Rouen, France
Cabinet Médical
🇫🇷Lille, France
CHU Nantes, Hôtel Dieu Clinique de Chirurgie digestive et endocrinienne (CCDE) Institut des maladies de l'Appareil Digestif (IMAD)
🇫🇷Nantes, France
Hôpital Saint-Joseph Service Hépato-Gastroentérologie
🇫🇷Marseille, France
MVZ Dres. Eisenbach, Simon, Schwarz
🇩🇪Leverkusen, Germany
Centre Hospitalier Universitaire (CHU) de Strasbourg Service de Chirurgie Digestive et Endocrinienne
🇫🇷Strasbourg, France
Gemeinschaftspraxis Dres. Balck
🇩🇪Meine, Germany
Azienda Ospedaliera Policlinico Consorziale di Bari Dipartimento di Gastroenterologia
🇮🇹Bari, Italy
Ospedale "San Paolo" - Unità Operativa Complessa di Gastroenterologia ed Endoscopia Digestiva
🇮🇹Bari, Italy
Ospedale Civile S. Agostino Estense - Divisione di Endoscopia Digestiva
🇮🇹Baggiovara, Italy
Ospedale Cardinal Massaia SOC Gastroenterologia ed Endoscopia Digestiva
🇮🇹Asti, Italy
Università degli Studi di Bari Policlinico Medicina Interna
🇮🇹Bari, Italy
AOU di Bologna - Policlinico S.Orsola Malpighi - Dipartimento di Scienze Mediche e Chirurgiche
🇮🇹Bologna, Italy
Azienda Ospedaliera Garibaldi Unità Operativa Complessa di Gastroenterologia
🇮🇹Catania, Italy
Policlinico Ss Annunziata - ASL 2 Lanciano Vasto Chieti UOSD Endoscopia Digestiva
🇮🇹Chieti, Italy
Ospedale Ciaccio - De Lellis Divisione di Gastroenterologia ed Endoscopia Digestiva
🇮🇹Catanzaro, Italy
Ospedale S. Salvatore di L'Aquila Unità Operativa di Gastroenterologia, Epatologia e Nutrizione
🇮🇹Coppito, Italy
Ospedale Civile San Giovanni di Dio - Divisione di Gastroenterologia ed Endoscopia Digestiva
🇮🇹Crotone, Italy
Ospedale Policlinico S.Martino Istituto di Ricovero e Cura per l'Oncologia Dipartimento di Medicina Interna e Specialità Mediche U.O. Clinica Gastroenterologica
🇮🇹Genova, Italy
Ente Ospedaliero Ospedali Galliera Chirurgia Generale
🇮🇹Genova, Italy
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
UNIMI - San Paolo (ASST Santi Paolo e Carlo) Medicina Generale
🇮🇹Milano, Italy
AOU Seconda Università degli Studi di Napoli Unità Operativa Complessa di Epato-Gastroenterologia
🇮🇹Napoli, Italy
Policlinico Federico II - UO di Epatogastroenterologia ed endoscopia digestiva
🇮🇹Napoli, Italy
AOU di Padova Unità Operativa Complessa di Gastroenterologia
🇮🇹Padova, Italy
Policlinico Federico II - UOSD Diagnosi Fisiopatologica e Terapia delle Malattie Motorie Digestive
🇮🇹Napoli, Italy
Fondazione IRCCS Policlinico San Matteo Dipartimento di Medicina Interna
🇮🇹Pavia, Italy
Ospedale Buccheri La Ferla Fetebenefratelli Unità Operativa di Gastroenterologia e Endoscopia Digestiva
🇮🇹Palermo, Italy
Ospedale Popoli Unità Operativa Semplice Dipartimentale Chirurgia Endoscopica
🇮🇹Popoli, Italy
PO Cisanello - AOU Pisana Unità Operativa Complessa di Gastroenterologia - AOUP Gastroenterologia Universitaria
🇮🇹Pisa, Italy
Fondazione Policlinico Universitario A. Gemelli Unità Operativa Complessa di Gastroenterologia e Malattie del Fegato
🇮🇹Roma, Italy
Ospedale Cristo Re - Divisione di Medicina Interna e Gastroenterologia
🇮🇹Roma, Italy
Azienda Ospedaliera San Giovanni Addolorata Gastroenterologia ed Endoscopia Digestiva
🇮🇹Roma, Italy
Ospedale Sant'Andrea - Gastroenterologia
🇮🇹Roma, Italy
Policlinico Universitario Campus Biomedico Unità Operativa Complessa di Gastroenterologia ed Endoscopia Digestiva
🇮🇹Roma, Italy
AOU OO. RR. San Giovanni di Dio e Ruggi d'Aragona - Dipartimento di Medicina e Chirurgia - Gastroenterologia
🇮🇹Salerno, Italy
Istituto Clinico Humanitas-Unità Operativa Malattie Infiammatorie Croniche Intestinali
🇮🇹Rozzano, Italy
Azienda Ospedaliera San Giovanni Battista Molinette - S.C. Gastroenterologia e Epatologia
🇮🇹Torino, Italy
Ospedale Sant'Anna Unità Operativa di Medicina Interna
🇮🇹San Fermo Della Battaglia, Italy
IRCCS Policlinico San Donato Unità Operativa Medicina Generale III, Gastroenterologia
🇮🇹San Donato Milanese, Italy
Ikazia ziekenhuis Gastroenterology
🇳🇱Rotterdam, Netherlands
VU Medisch Centrum Gastroenterology
🇳🇱Amsterdam, Netherlands
Meander Medisch Centrum Surgery
🇳🇱Amersfoort, Netherlands
Ospedale di Circolo e Fondazione Macchi Endoscopia
🇮🇹Varese, Italy
Azienda Ospedaliera Universitaria Integrata - UOC Gastroenterologia A- Borgo Trento-Dipartimento Medicina Generale
🇮🇹Verona, Italy
Hospital General Universitario de Alicante Servicio de Aparato Digestivo
🇪🇸Alicante, Spain
Centre Médic Teknon Servicio de Aparato Digestivo
🇪🇸Barcelona, Spain
Hospital Clínic Servicio de Gastroenterología
🇪🇸Barcelona, Spain
Hospital Vall d'Hebrón Servicio de Aparato Digestivo
🇪🇸Barcelona, Spain
Hospital Universitario de Belltvitge Servicio de Cirugía General y Digestiva
🇪🇸Hospitalet de Llobregat, Spain
Hospital General San Jorge de Huesca Servicio de Aparato Digestivo
🇪🇸Huesca, Spain
Hospital Costa del Sol Servicio Digestivo
🇪🇸Marbella, Spain
Hospital de Ourense Servicio de Aparato Digestivo
🇪🇸Orense, Spain
Hospital Universitario de Canarias Servicio de Gastroenterología
🇪🇸Santa Cruz De Tenerife, Spain
Yeovil District Hospital NHS Trust Department of Surgery
🇬🇧Yeovil, United Kingdom
Hospital Clínico Universitario Lozano Blesa Servicio de Aparato Digestivo
🇪🇸Zaragoza, Spain