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

October 13, 2021 updated by: Alfasigma S.p.A.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
193

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bobigny, France
        • Hôpital Avicenne Service Gastro-Entérologie
      • Lille, France
        • Cabinet Medical
      • Lille, France
        • Centre Hospitalier Regional Universitaire Claude Huriez Service de Chirurgie Digestive et Générale
      • Marseille, France
        • Hôpital Saint-Joseph Service Hépato-Gastroentérologie
      • Nantes, France
        • CHU Nantes, Hôtel Dieu Clinique de Chirurgie digestive et endocrinienne (CCDE) Institut des maladies de l'Appareil Digestif (IMAD)
      • Rouen, France
        • Hôpital Charles Nicolle - CHU Rouen Service Hépato-Gastroentérologie
      • Strasbourg, France
        • Centre Hospitalier Universitaire (CHU) de Strasbourg Service de Chirurgie Digestive et Endocrinienne
  • Germany
      • Essen, Germany
        • Gemeinschaftspraxis - Praxis Überruhr
      • Leipzig, Germany
        • Medamed GmbH Studienambulanz Leipzig
      • Leverkusen, Germany
        • MVZ Dres. Eisenbach, Simon, Schwarz
      • Meine, Germany
        • Gemeinschaftspraxis Dres. Balck
      • Rodgau, Germany
        • Praxis Dres. med. Naudts und Nowack
  • Italy
      • Asti, Italy
        • Ospedale Cardinal Massaia SOC Gastroenterologia ed Endoscopia Digestiva
      • Baggiovara, Italy
        • Ospedale Civile S. Agostino Estense - Divisione di Endoscopia Digestiva
      • Bari, 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
      • Bologna, Italy
        • AOU di Bologna - Policlinico S.Orsola Malpighi - Dipartimento di Scienze Mediche e Chirurgiche
      • Cagliari, Italy
        • AOU Cagliari - Policlinico Monserrato Gastroenterologia
      • Catania, Italy
        • Azienda Ospedaliera Garibaldi Unità Operativa Complessa di Gastroenterologia
      • Catanzaro, Italy
        • Ospedale Ciaccio - De Lellis Divisione di Gastroenterologia ed Endoscopia Digestiva
      • Chieti, Italy
        • Policlinico Ss Annunziata - ASL 2 Lanciano Vasto Chieti UOSD Endoscopia Digestiva
      • Como, Italy
        • Ospedale Valduce Unità Operativa Complessa di Gastroenterologia
      • Coppito, Italy
        • Ospedale S. Salvatore di L'Aquila Unità Operativa di Gastroenterologia, Epatologia e Nutrizione
      • Crotone, Italy
        • Ospedale Civile San Giovanni di Dio - Divisione di Gastroenterologia ed Endoscopia Digestiva
      • Genova, 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
      • Milano, Italy
        • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
      • Milano, Italy
        • UNIMI - San Paolo (ASST Santi Paolo e Carlo) Medicina Generale
      • Monza, Italy
        • Ospedale San Gerardo Endoscopia Digestiva
      • Napoli, 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
      • Padova, Italy
        • AOU di Padova Unità Operativa Complessa di Gastroenterologia
      • Palermo, Italy
        • Ospedale Buccheri La Ferla Fetebenefratelli Unità Operativa di Gastroenterologia e Endoscopia Digestiva
      • Pavia, Italy
        • Fondazione IRCCS Policlinico San Matteo Dipartimento di Medicina Interna
      • Pisa, Italy
        • PO Cisanello - AOU Pisana Unità Operativa Complessa di Gastroenterologia - AOUP Gastroenterologia Universitaria
      • Popoli, Italy
        • Ospedale Popoli Unità Operativa Semplice Dipartimentale Chirurgia Endoscopica
      • Roma, 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
      • Rozzano, Italy
        • Istituto Clinico Humanitas-Unità Operativa Malattie Infiammatorie Croniche Intestinali
      • Salerno, Italy
        • AOU OO. RR. San Giovanni di Dio e Ruggi d'Aragona - Dipartimento di Medicina e Chirurgia - Gastroenterologia
      • San Donato Milanese, Italy
        • IRCCS Policlinico San Donato Unità Operativa Medicina Generale III, Gastroenterologia
      • San Fermo Della Battaglia, Italy
        • Ospedale Sant'Anna Unità Operativa di Medicina Interna
      • Torino, Italy
        • Azienda Ospedaliera San Giovanni Battista Molinette - S.C. Gastroenterologia e Epatologia
      • Varese, Italy
        • Ospedale di Circolo e Fondazione Macchi Endoscopia
      • Verona, Italy
        • Azienda Ospedaliera Universitaria Integrata - UOC Gastroenterologia A- Borgo Trento-Dipartimento Medicina Generale
  • Netherlands
      • Amersfoort, Netherlands
        • Meander Medisch Centrum Surgery
      • Amsterdam, Netherlands
        • VU Medisch Centrum Gastroenterology
      • Rotterdam, Netherlands
        • Ikazia ziekenhuis Gastroenterology
  • Spain
      • Alicante, Spain
        • Hospital General Universitario de Alicante Servicio de Aparato Digestivo
      • Barcelona, 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
      • Hospitalet de Llobregat, Spain
        • Hospital Universitario de Belltvitge Servicio de Cirugía General y Digestiva
      • Huesca, Spain
        • Hospital General San Jorge de Huesca Servicio de Aparato Digestivo
      • Marbella, Spain
        • Hospital Costa del Sol Servicio Digestivo
      • Orense, Spain
        • Hospital de Ourense Servicio de Aparato Digestivo
      • Santa Cruz De Tenerife, Spain
        • Hospital Universitario de Canarias Servicio de Gastroenterología
      • Zaragoza, Spain
        • Hospital Clínico Universitario Lozano Blesa Servicio de Aparato Digestivo
  • United Kingdom
      • Yeovil, United Kingdom
        • Yeovil District Hospital NHS Trust Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Drug: Rifaximin delayed released 400mg Tablet
Rifaximin delayed released
Other Names:
  • Rifaximin-EIR
Experimental: 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
Drug: Rifaximin delayed released 400mg Tablet
Rifaximin delayed released
Other Names:
  • Rifaximin-EIR
Other: Placebo
Placebo BID + Placebo BID
Placebo Comparator: Placebo b.i.d.
(i.e. 2 x placebo tablets twice a day) for 10 consecutive days a month, for 12 months.
Other: Placebo
Placebo BID + Placebo BID

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Rate of patients with recurrence of diverticulitis and/or diverticular complications over the 12-month treatment period.
Time Frame: 12-month treatment period
12-month treatment period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
12-month treatment period
Time to diverticulitis recurrence or complication
Time Frame: 12-month treatment period
12-month treatment period
Rate of patients with diverticulitis-associated fever
Time Frame: 12-month treatment period
12-month treatment period
Left-lower quadrant abdominal pain intensity
Time Frame: 12-month treatment period
12-month treatment period
Left-lower quadrant abdominal pain duration
Time Frame: 12-month treatment period
12-month treatment period
Number of days in a year with left-lower quadrant abdominal pain
Time Frame: 12-month treatment period
12-month treatment period
Number of weeks in a year with episodes of prolonged (≥24 hours) left-lower quadrant abdominal pain
Time Frame: 12-month treatment period
12-month treatment period
Number of days in a year with any abdominal pain
Time Frame: 12-month treatment period
12-month treatment period
Number of weeks in a year with bloating
Time Frame: 12-month treatment period
12-month treatment period
Change in bowel habits
Time Frame: 12-month treatment period
Evaluated by Bristol Stool Scale
12-month treatment period
Rate of any hospitalization for diverticulitis
Time Frame: 12-month treatment period
12-month treatment period
Rate of hospitalization for diverticulitis without surgery
Time Frame: 12-month treatment period
12-month treatment period
Rate of elective surgery for diverticulitis
Time Frame: 12-month treatment period
12-month treatment period
Rate of emergency surgery for diverticulitis
Time Frame: 12-month treatment period
12-month treatment period
Change in Quality of Life
Time Frame: 12-month treatment period
Evaluated by SF36 Quality of Life Questionnaire
12-month treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alfasigma S.p.A.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Alessandro Blè, MD, Alfasigma S.p.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 22, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 22, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 6, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 20, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REDIV/002/17
  • 2017-002708-28 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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