Rifaximin Delayed Release for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications.
NCT ID: NCT03469050
Last Updated: 2021-10-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
193 participants
INTERVENTIONAL
2018-07-02
2020-12-22
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Rifaximin delayed released 800 mg b.i.d.
(i.e. 2 x 400 mg tablet twice a day; total daily dose: 1600 mg) for 10 consecutive days a month, for 12 months
Rifaximin delayed released 400mg Tablet
Rifaximin delayed released
Rifaximin delayed released 400 mg b.i.d
(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 400mg Tablet
Rifaximin delayed released
Placebo
Placebo BID + Placebo BID
Placebo b.i.d.
(i.e. 2 x placebo tablets twice a day) for 10 consecutive days a month, for 12 months.
Placebo
Placebo BID + Placebo BID
Interventions
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Rifaximin delayed released 400mg Tablet
Rifaximin delayed released
Placebo
Placebo BID + Placebo BID
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Alfasigma S.p.A.
INDUSTRY
Responsible Party
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Principal Investigators
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Alessandro Blè, MD
Role: STUDY_DIRECTOR
Alfasigma S.p.A.
Locations
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Hôpital Avicenne Service Gastro-entérologie
Bobigny, , France
Cabinet Médical
Lille, , France
Centre Hospitalier Regional Universitaire Claude Huriez Service de Chirurgie Digestive et Générale
Lille, , France
Hôpital Saint-Joseph Service Hépato-Gastroentérologie
Marseille, , France
CHU Nantes, Hôtel Dieu Clinique de Chirurgie digestive et endocrinienne (CCDE) Institut des maladies de l'Appareil Digestif (IMAD)
Nantes, , France
Hôpital Charles Nicolle - CHU Rouen Service Hépato-Gastroentérologie
Rouen, , France
Centre Hospitalier Universitaire (CHU) de Strasbourg Service de Chirurgie Digestive et Endocrinienne
Strasbourg, , France
Gemeinschaftspraxis - Praxis Überruhr
Essen, , Germany
Medamed GmbH Studienambulanz Leipzig
Leipzig, , Germany
MVZ Dres. Eisenbach, Simon, Schwarz
Leverkusen, , Germany
Gemeinschaftspraxis Dres. Balck
Meine, , Germany
Praxis Dres. med. Naudts und Nowack
Rodgau, , Germany
Ospedale Cardinal Massaia SOC Gastroenterologia ed Endoscopia Digestiva
Asti, , Italy
Ospedale Civile S. Agostino Estense - Divisione di Endoscopia Digestiva
Baggiovara, , Italy
Azienda Ospedaliera Policlinico Consorziale di Bari Dipartimento di Gastroenterologia
Bari, , Italy
Ospedale "San Paolo" - Unità Operativa Complessa di Gastroenterologia ed Endoscopia Digestiva
Bari, , 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
AOU Cagliari - Policlinico Monserrato Gastroenterologia
Cagliari, , Italy
Azienda Ospedaliera Garibaldi Unità Operativa Complessa di Gastroenterologia
Catania, , Italy
Ospedale Ciaccio - De Lellis Divisione di Gastroenterologia ed Endoscopia Digestiva
Catanzaro, , Italy
Policlinico Ss Annunziata - ASL 2 Lanciano Vasto Chieti UOSD Endoscopia Digestiva
Chieti, , Italy
Ospedale Valduce Unità Operativa Complessa di Gastroenterologia
Como, , 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
Ente Ospedaliero Ospedali Galliera Chirurgia Generale
Genova, , 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
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Milan, , Italy
UNIMI - San Paolo (ASST Santi Paolo e Carlo) Medicina Generale
Milan, , Italy
Ospedale San Gerardo Endoscopia Digestiva
Monza, , 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
Policlinico Federico II - UOSD Diagnosi Fisiopatologica e Terapia delle Malattie Motorie Digestive
Napoli, , Italy
AOU di Padova Unità Operativa Complessa di Gastroenterologia
Padua, , Italy
Ospedale Buccheri La Ferla Fetebenefratelli Unità Operativa di Gastroenterologia e Endoscopia Digestiva
Palermo, , Italy
Fondazione IRCCS Policlinico San Matteo Dipartimento di Medicina Interna
Pavia, , Italy
PO Cisanello - AOU Pisana Unità Operativa Complessa di Gastroenterologia - AOUP Gastroenterologia Universitaria
Pisa, , Italy
Ospedale Popoli Unità Operativa Semplice Dipartimentale Chirurgia Endoscopica
Popoli, , Italy
Azienda Ospedaliera San Giovanni Addolorata Gastroenterologia ed Endoscopia Digestiva
Roma, , 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
Ospedale Sant'Andrea - Gastroenterologia
Roma, , Italy
Policlinico Universitario Campus Biomedico Unità Operativa Complessa di Gastroenterologia ed Endoscopia Digestiva
Roma, , Italy
Istituto Clinico Humanitas-Unità Operativa Malattie Infiammatorie Croniche Intestinali
Rozzano, , Italy
AOU OO. RR. San Giovanni di Dio e Ruggi d'Aragona - Dipartimento di Medicina e Chirurgia - Gastroenterologia
Salerno, , Italy
IRCCS Policlinico San Donato Unità Operativa Medicina Generale III, Gastroenterologia
San Donato Milanese, , Italy
Ospedale Sant'Anna Unità Operativa di Medicina Interna
San Fermo della Battaglia, , Italy
Azienda Ospedaliera San Giovanni Battista Molinette - S.C. Gastroenterologia e Epatologia
Torino, , Italy
Ospedale di Circolo e Fondazione Macchi Endoscopia
Varese, , Italy
Azienda Ospedaliera Universitaria Integrata - UOC Gastroenterologia A- Borgo Trento-Dipartimento Medicina Generale
Verona, , Italy
Meander Medisch Centrum Surgery
Amersfoort, , Netherlands
VU Medisch Centrum Gastroenterology
Amsterdam, , Netherlands
Ikazia ziekenhuis Gastroenterology
Rotterdam, , Netherlands
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 General San Jorge de Huesca Servicio de Aparato Digestivo
Huesca, , Spain
Hospital Universitario de Belltvitge Servicio de Cirugía General y Digestiva
L'Hospitalet de Llobregat, , Spain
Hospital Costa del Sol Servicio Digestivo
Marbella, , Spain
Hospital de Ourense Servicio de Aparato Digestivo
Ourense, , Spain
Hospital Universitario de Canarias Servicio de Gastroenterología
Santa Cruz de Tenerife, , Spain
Hospital Clínico Universitario Lozano Blesa Servicio de Aparato Digestivo
Zaragoza, , Spain
Yeovil District Hospital NHS Trust Department of Surgery
Yeovil, , United Kingdom
Countries
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Other Identifiers
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2017-002708-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
REDIV/002/17
Identifier Type: -
Identifier Source: org_study_id