Rifaximin Delayed Release for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications.

Diverticulitis Clinical Trial

— ROAD  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03469050
• Other study ID #: REDIV/002/17
• Secondary ID: 2017-002708-28
• Status: Terminated
• Phase: Phase 2/Phase 3
• Start date: July 2, 2018
• Est. completion date: December 22, 2020

Study information

• Verified date: July 2021
• Source: Alfasigma S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 193
• Est. completion date: December 22, 2020
• Est. primary completion date: December 22, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Key Inclusion Criteria:

• 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 Criteria:

• 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

Related Conditions & MeSH terms

• Diverticulitis

Intervention

Drug:
• Rifaximin delayed released 400mg Tablet
Rifaximin delayed released

Other:
• Placebo
Placebo BID + Placebo BID

Locations

Country	Name	City	State
France	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
Germany	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
Italy	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	Milano
Italy	UNIMI - San Paolo (ASST Santi Paolo e Carlo) Medicina Generale	Milano
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	Padova
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
Netherlands	Meander Medisch Centrum Surgery	Amersfoort
Netherlands	VU Medisch Centrum Gastroenterology	Amsterdam
Netherlands	Ikazia ziekenhuis Gastroenterology	Rotterdam
Spain	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	Hospital Clínico Universitario Lozano Blesa Servicio de Aparato Digestivo	Zaragoza
United Kingdom	Yeovil District Hospital NHS Trust Department of Surgery	Yeovil

Sponsors (1)

Lead Sponsor	Collaborator
Alfasigma S.p.A.

Countries where clinical trial is conducted

France,  Germany,  Italy,  Netherlands,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of patients with recurrence of diverticulitis and/or diverticular complications over the 12-month treatment period.		12-month treatment period
Secondary	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
Secondary	Time to diverticulitis recurrence or complication		12-month treatment period
Secondary	Rate of patients with diverticulitis-associated fever		12-month treatment period
Secondary	Left-lower quadrant abdominal pain intensity		12-month treatment period
Secondary	Left-lower quadrant abdominal pain duration		12-month treatment period
Secondary	Number of days in a year with left-lower quadrant abdominal pain		12-month treatment period
Secondary	Number of weeks in a year with episodes of prolonged (=24 hours) left-lower quadrant abdominal pain		12-month treatment period
Secondary	Number of days in a year with any abdominal pain		12-month treatment period
Secondary	Number of weeks in a year with bloating		12-month treatment period
Secondary	Change in bowel habits	Evaluated by Bristol Stool Scale	12-month treatment period
Secondary	Rate of any hospitalization for diverticulitis		12-month treatment period
Secondary	Rate of hospitalization for diverticulitis without surgery		12-month treatment period
Secondary	Rate of elective surgery for diverticulitis		12-month treatment period
Secondary	Rate of emergency surgery for diverticulitis		12-month treatment period
Secondary	Change in Quality of Life	Evaluated by SF36 Quality of Life Questionnaire	12-month treatment period