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

Primary Purpose

Diverticulitis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Rifaximin delayed released 400mg Tablet
Placebo
Sponsored by
Alfasigma S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diverticulitis focused on measuring Recurrent acute diverticulitis, Prevention, Diverticular complications, Rifaximin delayed release, Diverticulitis, SIBO

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Avicenne Service Gastro-entérologie
  • Cabinet Médical
  • Centre Hospitalier Regional Universitaire Claude Huriez Service de Chirurgie Digestive et Générale
  • Hôpital Saint-Joseph Service Hépato-Gastroentérologie
  • CHU Nantes, Hôtel Dieu Clinique de Chirurgie digestive et endocrinienne (CCDE) Institut des maladies de l'Appareil Digestif (IMAD)
  • Hôpital Charles Nicolle - CHU Rouen Service Hépato-Gastroentérologie
  • Centre Hospitalier Universitaire (CHU) de Strasbourg Service de Chirurgie Digestive et Endocrinienne
  • Gemeinschaftspraxis - Praxis Überruhr
  • Medamed GmbH Studienambulanz Leipzig
  • MVZ Dres. Eisenbach, Simon, Schwarz
  • Gemeinschaftspraxis Dres. Balck
  • Praxis Dres. med. Naudts und Nowack
  • Ospedale Cardinal Massaia SOC Gastroenterologia ed Endoscopia Digestiva
  • Ospedale Civile S. Agostino Estense - Divisione di Endoscopia Digestiva
  • Azienda Ospedaliera Policlinico Consorziale di Bari Dipartimento di Gastroenterologia
  • Ospedale "San Paolo" - Unità Operativa Complessa di Gastroenterologia ed Endoscopia Digestiva
  • Università degli Studi di Bari Policlinico Medicina Interna
  • AOU di Bologna - Policlinico S.Orsola Malpighi - Dipartimento di Scienze Mediche e Chirurgiche
  • AOU Cagliari - Policlinico Monserrato Gastroenterologia
  • Azienda Ospedaliera Garibaldi Unità Operativa Complessa di Gastroenterologia
  • Ospedale Ciaccio - De Lellis Divisione di Gastroenterologia ed Endoscopia Digestiva
  • Policlinico Ss Annunziata - ASL 2 Lanciano Vasto Chieti UOSD Endoscopia Digestiva
  • Ospedale Valduce Unità Operativa Complessa di Gastroenterologia
  • Ospedale S. Salvatore di L'Aquila Unità Operativa di Gastroenterologia, Epatologia e Nutrizione
  • Ospedale Civile San Giovanni di Dio - Divisione di Gastroenterologia ed Endoscopia Digestiva
  • Ente Ospedaliero Ospedali Galliera Chirurgia Generale
  • Ospedale Policlinico S.Martino Istituto di Ricovero e Cura per l'Oncologia Dipartimento di Medicina Interna e Specialità Mediche U.O. Clinica Gastroenterologica
  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
  • UNIMI - San Paolo (ASST Santi Paolo e Carlo) Medicina Generale
  • Ospedale San Gerardo Endoscopia Digestiva
  • AOU Seconda Università degli Studi di Napoli Unità Operativa Complessa di Epato-Gastroenterologia
  • Policlinico Federico II - UO di Epatogastroenterologia ed endoscopia digestiva
  • Policlinico Federico II - UOSD Diagnosi Fisiopatologica e Terapia delle Malattie Motorie Digestive
  • AOU di Padova Unità Operativa Complessa di Gastroenterologia
  • Ospedale Buccheri La Ferla Fetebenefratelli Unità Operativa di Gastroenterologia e Endoscopia Digestiva
  • Fondazione IRCCS Policlinico San Matteo Dipartimento di Medicina Interna
  • PO Cisanello - AOU Pisana Unità Operativa Complessa di Gastroenterologia - AOUP Gastroenterologia Universitaria
  • Ospedale Popoli Unità Operativa Semplice Dipartimentale Chirurgia Endoscopica
  • Azienda Ospedaliera San Giovanni Addolorata Gastroenterologia ed Endoscopia Digestiva
  • Fondazione Policlinico Universitario A. Gemelli Unità Operativa Complessa di Gastroenterologia e Malattie del Fegato
  • Ospedale Cristo Re - Divisione di Medicina Interna e Gastroenterologia
  • Ospedale Sant'Andrea - Gastroenterologia
  • Policlinico Universitario Campus Biomedico Unità Operativa Complessa di Gastroenterologia ed Endoscopia Digestiva
  • Istituto Clinico Humanitas-Unità Operativa Malattie Infiammatorie Croniche Intestinali
  • AOU OO. RR. San Giovanni di Dio e Ruggi d'Aragona - Dipartimento di Medicina e Chirurgia - Gastroenterologia
  • IRCCS Policlinico San Donato Unità Operativa Medicina Generale III, Gastroenterologia
  • Ospedale Sant'Anna Unità Operativa di Medicina Interna
  • Azienda Ospedaliera San Giovanni Battista Molinette - S.C. Gastroenterologia e Epatologia
  • Ospedale di Circolo e Fondazione Macchi Endoscopia
  • Azienda Ospedaliera Universitaria Integrata - UOC Gastroenterologia A- Borgo Trento-Dipartimento Medicina Generale
  • Meander Medisch Centrum Surgery
  • VU Medisch Centrum Gastroenterology
  • Ikazia ziekenhuis Gastroenterology
  • Hospital General Universitario de Alicante Servicio de Aparato Digestivo
  • Centre Médic Teknon Servicio de Aparato Digestivo
  • Hospital Clínic Servicio de Gastroenterología
  • Hospital Vall d'Hebrón Servicio de Aparato Digestivo
  • Hospital Universitario de Belltvitge Servicio de Cirugía General y Digestiva
  • Hospital General San Jorge de Huesca Servicio de Aparato Digestivo
  • Hospital Costa del Sol Servicio Digestivo
  • Hospital de Ourense Servicio de Aparato Digestivo
  • Hospital Universitario de Canarias Servicio de Gastroenterología
  • Hospital Clínico Universitario Lozano Blesa Servicio de Aparato Digestivo
  • Yeovil District Hospital NHS Trust Department of Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Rifaximin delayed released 800 mg b.i.d.

Rifaximin delayed released 400 mg b.i.d

Placebo b.i.d.

Arm Description

(i.e. 2 x 400 mg tablet twice a day; total daily dose: 1600 mg) for 10 consecutive days a month, for 12 months

(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

(i.e. 2 x placebo tablets twice a day) for 10 consecutive days a month, for 12 months.

Outcomes

Primary Outcome Measures

Rate of patients with recurrence of diverticulitis and/or diverticular complications over the 12-month treatment period.

Secondary Outcome Measures

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]
Time to diverticulitis recurrence or complication
Rate of patients with diverticulitis-associated fever
Left-lower quadrant abdominal pain intensity
Left-lower quadrant abdominal pain duration
Number of days in a year with left-lower quadrant abdominal pain
Number of weeks in a year with episodes of prolonged (≥24 hours) left-lower quadrant abdominal pain
Number of days in a year with any abdominal pain
Number of weeks in a year with bloating
Change in bowel habits
Evaluated by Bristol Stool Scale
Rate of any hospitalization for diverticulitis
Rate of hospitalization for diverticulitis without surgery
Rate of elective surgery for diverticulitis
Rate of emergency surgery for diverticulitis
Change in Quality of Life
Evaluated by SF36 Quality of Life Questionnaire

Full Information

First Posted
March 6, 2018
Last Updated
October 13, 2021
Sponsor
Alfasigma S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT03469050
Brief Title
Rifaximin Delayed Release for the Prevention of Recurrent Acute Diverticulitis and Diverticular Complications.
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Sponsor's decision
Study Start Date
July 2, 2018 (Actual)
Primary Completion Date
December 22, 2020 (Actual)
Study Completion Date
December 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alfasigma S.p.A.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulitis
Keywords
Recurrent acute diverticulitis, Prevention, Diverticular complications, Rifaximin delayed release, Diverticulitis, SIBO

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This study is a phase II, multicenter, double-blind, placebo-controlled, randomized clinical trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
193 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rifaximin delayed released 800 mg b.i.d.
Arm Type
Experimental
Arm Description
(i.e. 2 x 400 mg tablet twice a day; total daily dose: 1600 mg) for 10 consecutive days a month, for 12 months
Arm Title
Rifaximin delayed released 400 mg b.i.d
Arm Type
Experimental
Arm Description
(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
Arm Title
Placebo b.i.d.
Arm Type
Placebo Comparator
Arm Description
(i.e. 2 x placebo tablets twice a day) for 10 consecutive days a month, for 12 months.
Intervention Type
Drug
Intervention Name(s)
Rifaximin delayed released 400mg Tablet
Other Intervention Name(s)
Rifaximin-EIR
Intervention Description
Rifaximin delayed released
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo BID + Placebo BID
Primary Outcome Measure Information:
Title
Rate of patients with recurrence of diverticulitis and/or diverticular complications over the 12-month treatment period.
Time Frame
12-month treatment period
Secondary Outcome Measure Information:
Title
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]
Time Frame
12-month treatment period
Title
Time to diverticulitis recurrence or complication
Time Frame
12-month treatment period
Title
Rate of patients with diverticulitis-associated fever
Time Frame
12-month treatment period
Title
Left-lower quadrant abdominal pain intensity
Time Frame
12-month treatment period
Title
Left-lower quadrant abdominal pain duration
Time Frame
12-month treatment period
Title
Number of days in a year with left-lower quadrant abdominal pain
Time Frame
12-month treatment period
Title
Number of weeks in a year with episodes of prolonged (≥24 hours) left-lower quadrant abdominal pain
Time Frame
12-month treatment period
Title
Number of days in a year with any abdominal pain
Time Frame
12-month treatment period
Title
Number of weeks in a year with bloating
Time Frame
12-month treatment period
Title
Change in bowel habits
Description
Evaluated by Bristol Stool Scale
Time Frame
12-month treatment period
Title
Rate of any hospitalization for diverticulitis
Time Frame
12-month treatment period
Title
Rate of hospitalization for diverticulitis without surgery
Time Frame
12-month treatment period
Title
Rate of elective surgery for diverticulitis
Time Frame
12-month treatment period
Title
Rate of emergency surgery for diverticulitis
Time Frame
12-month treatment period
Title
Change in Quality of Life
Description
Evaluated by SF36 Quality of Life Questionnaire
Time Frame
12-month treatment period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alessandro Blè, MD
Organizational Affiliation
Alfasigma S.p.A.
Official's Role
Study Director
Facility Information:
Facility Name
Hôpital Avicenne Service Gastro-entérologie
City
Bobigny
Country
France
Facility Name
Cabinet Médical
City
Lille
Country
France
Facility Name
Centre Hospitalier Regional Universitaire Claude Huriez Service de Chirurgie Digestive et Générale
City
Lille
Country
France
Facility Name
Hôpital Saint-Joseph Service Hépato-Gastroentérologie
City
Marseille
Country
France
Facility Name
CHU Nantes, Hôtel Dieu Clinique de Chirurgie digestive et endocrinienne (CCDE) Institut des maladies de l'Appareil Digestif (IMAD)
City
Nantes
Country
France
Facility Name
Hôpital Charles Nicolle - CHU Rouen Service Hépato-Gastroentérologie
City
Rouen
Country
France
Facility Name
Centre Hospitalier Universitaire (CHU) de Strasbourg Service de Chirurgie Digestive et Endocrinienne
City
Strasbourg
Country
France
Facility Name
Gemeinschaftspraxis - Praxis Überruhr
City
Essen
Country
Germany
Facility Name
Medamed GmbH Studienambulanz Leipzig
City
Leipzig
Country
Germany
Facility Name
MVZ Dres. Eisenbach, Simon, Schwarz
City
Leverkusen
Country
Germany
Facility Name
Gemeinschaftspraxis Dres. Balck
City
Meine
Country
Germany
Facility Name
Praxis Dres. med. Naudts und Nowack
City
Rodgau
Country
Germany
Facility Name
Ospedale Cardinal Massaia SOC Gastroenterologia ed Endoscopia Digestiva
City
Asti
Country
Italy
Facility Name
Ospedale Civile S. Agostino Estense - Divisione di Endoscopia Digestiva
City
Baggiovara
Country
Italy
Facility Name
Azienda Ospedaliera Policlinico Consorziale di Bari Dipartimento di Gastroenterologia
City
Bari
Country
Italy
Facility Name
Ospedale "San Paolo" - Unità Operativa Complessa di Gastroenterologia ed Endoscopia Digestiva
City
Bari
Country
Italy
Facility Name
Università degli Studi di Bari Policlinico Medicina Interna
City
Bari
Country
Italy
Facility Name
AOU di Bologna - Policlinico S.Orsola Malpighi - Dipartimento di Scienze Mediche e Chirurgiche
City
Bologna
Country
Italy
Facility Name
AOU Cagliari - Policlinico Monserrato Gastroenterologia
City
Cagliari
Country
Italy
Facility Name
Azienda Ospedaliera Garibaldi Unità Operativa Complessa di Gastroenterologia
City
Catania
Country
Italy
Facility Name
Ospedale Ciaccio - De Lellis Divisione di Gastroenterologia ed Endoscopia Digestiva
City
Catanzaro
Country
Italy
Facility Name
Policlinico Ss Annunziata - ASL 2 Lanciano Vasto Chieti UOSD Endoscopia Digestiva
City
Chieti
Country
Italy
Facility Name
Ospedale Valduce Unità Operativa Complessa di Gastroenterologia
City
Como
Country
Italy
Facility Name
Ospedale S. Salvatore di L'Aquila Unità Operativa di Gastroenterologia, Epatologia e Nutrizione
City
Coppito
Country
Italy
Facility Name
Ospedale Civile San Giovanni di Dio - Divisione di Gastroenterologia ed Endoscopia Digestiva
City
Crotone
Country
Italy
Facility Name
Ente Ospedaliero Ospedali Galliera Chirurgia Generale
City
Genova
Country
Italy
Facility Name
Ospedale Policlinico S.Martino Istituto di Ricovero e Cura per l'Oncologia Dipartimento di Medicina Interna e Specialità Mediche U.O. Clinica Gastroenterologica
City
Genova
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
City
Milano
Country
Italy
Facility Name
UNIMI - San Paolo (ASST Santi Paolo e Carlo) Medicina Generale
City
Milano
Country
Italy
Facility Name
Ospedale San Gerardo Endoscopia Digestiva
City
Monza
Country
Italy
Facility Name
AOU Seconda Università degli Studi di Napoli Unità Operativa Complessa di Epato-Gastroenterologia
City
Napoli
Country
Italy
Facility Name
Policlinico Federico II - UO di Epatogastroenterologia ed endoscopia digestiva
City
Napoli
Country
Italy
Facility Name
Policlinico Federico II - UOSD Diagnosi Fisiopatologica e Terapia delle Malattie Motorie Digestive
City
Napoli
Country
Italy
Facility Name
AOU di Padova Unità Operativa Complessa di Gastroenterologia
City
Padova
Country
Italy
Facility Name
Ospedale Buccheri La Ferla Fetebenefratelli Unità Operativa di Gastroenterologia e Endoscopia Digestiva
City
Palermo
Country
Italy
Facility Name
Fondazione IRCCS Policlinico San Matteo Dipartimento di Medicina Interna
City
Pavia
Country
Italy
Facility Name
PO Cisanello - AOU Pisana Unità Operativa Complessa di Gastroenterologia - AOUP Gastroenterologia Universitaria
City
Pisa
Country
Italy
Facility Name
Ospedale Popoli Unità Operativa Semplice Dipartimentale Chirurgia Endoscopica
City
Popoli
Country
Italy
Facility Name
Azienda Ospedaliera San Giovanni Addolorata Gastroenterologia ed Endoscopia Digestiva
City
Roma
Country
Italy
Facility Name
Fondazione Policlinico Universitario A. Gemelli Unità Operativa Complessa di Gastroenterologia e Malattie del Fegato
City
Roma
Country
Italy
Facility Name
Ospedale Cristo Re - Divisione di Medicina Interna e Gastroenterologia
City
Roma
Country
Italy
Facility Name
Ospedale Sant'Andrea - Gastroenterologia
City
Roma
Country
Italy
Facility Name
Policlinico Universitario Campus Biomedico Unità Operativa Complessa di Gastroenterologia ed Endoscopia Digestiva
City
Roma
Country
Italy
Facility Name
Istituto Clinico Humanitas-Unità Operativa Malattie Infiammatorie Croniche Intestinali
City
Rozzano
Country
Italy
Facility Name
AOU OO. RR. San Giovanni di Dio e Ruggi d'Aragona - Dipartimento di Medicina e Chirurgia - Gastroenterologia
City
Salerno
Country
Italy
Facility Name
IRCCS Policlinico San Donato Unità Operativa Medicina Generale III, Gastroenterologia
City
San Donato Milanese
Country
Italy
Facility Name
Ospedale Sant'Anna Unità Operativa di Medicina Interna
City
San Fermo Della Battaglia
Country
Italy
Facility Name
Azienda Ospedaliera San Giovanni Battista Molinette - S.C. Gastroenterologia e Epatologia
City
Torino
Country
Italy
Facility Name
Ospedale di Circolo e Fondazione Macchi Endoscopia
City
Varese
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Integrata - UOC Gastroenterologia A- Borgo Trento-Dipartimento Medicina Generale
City
Verona
Country
Italy
Facility Name
Meander Medisch Centrum Surgery
City
Amersfoort
Country
Netherlands
Facility Name
VU Medisch Centrum Gastroenterology
City
Amsterdam
Country
Netherlands
Facility Name
Ikazia ziekenhuis Gastroenterology
City
Rotterdam
Country
Netherlands
Facility Name
Hospital General Universitario de Alicante Servicio de Aparato Digestivo
City
Alicante
Country
Spain
Facility Name
Centre Médic Teknon Servicio de Aparato Digestivo
City
Barcelona
Country
Spain
Facility Name
Hospital Clínic Servicio de Gastroenterología
City
Barcelona
Country
Spain
Facility Name
Hospital Vall d'Hebrón Servicio de Aparato Digestivo
City
Barcelona
Country
Spain
Facility Name
Hospital Universitario de Belltvitge Servicio de Cirugía General y Digestiva
City
Hospitalet de Llobregat
Country
Spain
Facility Name
Hospital General San Jorge de Huesca Servicio de Aparato Digestivo
City
Huesca
Country
Spain
Facility Name
Hospital Costa del Sol Servicio Digestivo
City
Marbella
Country
Spain
Facility Name
Hospital de Ourense Servicio de Aparato Digestivo
City
Orense
Country
Spain
Facility Name
Hospital Universitario de Canarias Servicio de Gastroenterología
City
Santa Cruz De Tenerife
Country
Spain
Facility Name
Hospital Clínico Universitario Lozano Blesa Servicio de Aparato Digestivo
City
Zaragoza
Country
Spain
Facility Name
Yeovil District Hospital NHS Trust Department of Surgery
City
Yeovil
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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