Study Stopped
Sponsor's decision
Rifaximin Delayed Release for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications.
ROAD
Rifaximin Delayed Release (400 mg Tablet) for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications. A Phase II, Multicenter, Double-blind, Placebo-controlled, Randomized Clinical Trial
2 other identifiers
interventional
193
6 countries
64
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jul 2018
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 6, 2018
CompletedFirst Posted
Study publicly available on registry
March 19, 2018
CompletedStudy Start
First participant enrolled
July 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 22, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 22, 2020
CompletedOctober 20, 2021
July 1, 2021
2.5 years
March 6, 2018
October 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of patients with recurrence of diverticulitis and/or diverticular complications over the 12-month treatment period.
12-month treatment period
Secondary Outcomes (15)
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
- +10 more secondary outcomes
Study Arms (3)
Rifaximin delayed released 800 mg b.i.d.
EXPERIMENTAL(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 400 mg b.i.d
EXPERIMENTAL(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 COMPARATOR(i.e. 2 x placebo tablets twice a day) for 10 consecutive days a month, for 12 months.
Interventions
Rifaximin delayed released
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Alfasigma S.p.A.lead
Study Sites (64)
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Alessandro Blè, MD
Alfasigma S.p.A.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2018
First Posted
March 19, 2018
Study Start
July 2, 2018
Primary Completion
December 22, 2020
Study Completion
December 22, 2020
Last Updated
October 20, 2021
Record last verified: 2021-07