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DiverticulitisPhase 2/3ROADNCT03469050

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

A Phase 2/3 study testing Rifaximin delayed released 400mg Tablet in people with Diverticulitis, run by Alfasigma S.p.A. at 64 sites in 6 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Diverticulitis
What is being tested?
Rifaximin delayed released 400mg Tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
193 participants
Where
64 sitesin 6 countries
Study dates
2 Jul 2018to 22 Dec 2020
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.
Show all 11Show fewer
  • 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

Trial locations and contacts

64 sites in 6 countries.

64 sites in 6 countries

Italy38 sites

  • Ospedale Cardinal Massaia SOC Gastroenterologia ed Endoscopia Digestiva

    Asti

  • Ospedale Civile S. Agostino Estense - Divisione di Endoscopia Digestiva

    Baggiovara

  • Azienda Ospedaliera Policlinico Consorziale di Bari Dipartimento di Gastroenterologia

    Bari

  • Ospedale "San Paolo" - Unità Operativa Complessa di Gastroenterologia ed Endoscopia Digestiva

    Bari

  • Università degli Studi di Bari Policlinico Medicina Interna

    Bari

  • AOU di Bologna - Policlinico S.Orsola Malpighi - Dipartimento di Scienze Mediche e Chirurgiche

    Bologna

  • AOU Cagliari - Policlinico Monserrato Gastroenterologia

    Cagliari

  • Azienda Ospedaliera Garibaldi Unità Operativa Complessa di Gastroenterologia

    Catania

  • Ospedale Ciaccio - De Lellis Divisione di Gastroenterologia ed Endoscopia Digestiva

    Catanzaro

  • Policlinico Ss Annunziata - ASL 2 Lanciano Vasto Chieti UOSD Endoscopia Digestiva

    Chieti

  • Ospedale Valduce Unità Operativa Complessa di Gastroenterologia

    Como

  • Ospedale S. Salvatore di L'Aquila Unità Operativa di Gastroenterologia, Epatologia e Nutrizione

    Coppito

  • Ospedale Civile San Giovanni di Dio - Divisione di Gastroenterologia ed Endoscopia Digestiva

    Crotone

  • Ente Ospedaliero Ospedali Galliera Chirurgia Generale

    Genova

  • Ospedale Policlinico S.Martino Istituto di Ricovero e Cura per l'Oncologia Dipartimento di Medicina Interna e Specialità Mediche U.O. Clinica Gastroenterologica

    Genova

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    Milan

  • UNIMI - San Paolo (ASST Santi Paolo e Carlo) Medicina Generale

    Milan

  • Ospedale San Gerardo Endoscopia Digestiva

    Monza

  • AOU Seconda Università degli Studi di Napoli Unità Operativa Complessa di Epato-Gastroenterologia

    Naples

  • Policlinico Federico II - UO di Epatogastroenterologia ed endoscopia digestiva

    Naples

  • Policlinico Federico II - UOSD Diagnosi Fisiopatologica e Terapia delle Malattie Motorie Digestive

    Naples

  • AOU di Padova Unità Operativa Complessa di Gastroenterologia

    Padova

  • Ospedale Buccheri La Ferla Fetebenefratelli Unità Operativa di Gastroenterologia e Endoscopia Digestiva

    Palermo

  • Fondazione IRCCS Policlinico San Matteo Dipartimento di Medicina Interna

    Pavia

  • PO Cisanello - AOU Pisana Unità Operativa Complessa di Gastroenterologia - AOUP Gastroenterologia Universitaria

    Pisa

  • Ospedale Popoli Unità Operativa Semplice Dipartimentale Chirurgia Endoscopica

    Popoli

  • Azienda Ospedaliera San Giovanni Addolorata Gastroenterologia ed Endoscopia Digestiva

    Roma

  • Fondazione Policlinico Universitario A. Gemelli Unità Operativa Complessa di Gastroenterologia e Malattie del Fegato

    Roma

  • Ospedale Cristo Re - Divisione di Medicina Interna e Gastroenterologia

    Roma

  • Ospedale Sant'Andrea - Gastroenterologia

    Roma

  • Policlinico Universitario Campus Biomedico Unità Operativa Complessa di Gastroenterologia ed Endoscopia Digestiva

    Roma

  • Istituto Clinico Humanitas-Unità Operativa Malattie Infiammatorie Croniche Intestinali

    Rozzano

  • AOU OO. RR. San Giovanni di Dio e Ruggi d'Aragona - Dipartimento di Medicina e Chirurgia - Gastroenterologia

    Salerno

  • IRCCS Policlinico San Donato Unità Operativa Medicina Generale III, Gastroenterologia

    San Donato Milanese

  • Ospedale Sant'Anna Unità Operativa di Medicina Interna

    San Fermo della Battaglia

  • Azienda Ospedaliera San Giovanni Battista Molinette - S.C. Gastroenterologia e Epatologia

    Torino

  • Ospedale di Circolo e Fondazione Macchi Endoscopia

    Varese

  • Azienda Ospedaliera Universitaria Integrata - UOC Gastroenterologia A- Borgo Trento-Dipartimento Medicina Generale

    Verona

Other trials in Italy

Spain10 sites

  • Hospital General Universitario de Alicante Servicio de Aparato Digestivo

    Alicante

  • Centre Médic Teknon Servicio de Aparato Digestivo

    Barcelona

  • Hospital Clínic Servicio de Gastroenterología

    Barcelona

  • Hospital Vall d'Hebrón Servicio de Aparato Digestivo

    Barcelona

  • Hospital General San Jorge de Huesca Servicio de Aparato Digestivo

    Huesca

  • Hospital Universitario de Belltvitge Servicio de Cirugía General y Digestiva

    L'Hospitalet de Llobregat

  • Hospital Costa del Sol Servicio Digestivo

    Marbella

  • Hospital de Ourense Servicio de Aparato Digestivo

    Ourense

  • Hospital Universitario de Canarias Servicio de Gastroenterología

    Santa Cruz de Tenerife

  • Hospital Clínico Universitario Lozano Blesa Servicio de Aparato Digestivo

    Zaragoza

Other trials in Spain

France7 sites

  • Hôpital Avicenne Service Gastro-entérologie

    Bobigny

  • Cabinet Médical

    Lille

  • Centre Hospitalier Regional Universitaire Claude Huriez Service de Chirurgie Digestive et Générale

    Lille

  • Hôpital Saint-Joseph Service Hépato-Gastroentérologie

    Marseille

  • CHU Nantes, Hôtel Dieu Clinique de Chirurgie digestive et endocrinienne (CCDE) Institut des maladies de l'Appareil Digestif (IMAD)

    Nantes

  • Hôpital Charles Nicolle - CHU Rouen Service Hépato-Gastroentérologie

    Rouen

  • Centre Hospitalier Universitaire (CHU) de Strasbourg Service de Chirurgie Digestive et Endocrinienne

    Strasbourg

Other trials in France

Germany5 sites

  • Gemeinschaftspraxis - Praxis Überruhr

    Essen

  • Medamed GmbH Studienambulanz Leipzig

    Leipzig

  • MVZ Dres. Eisenbach, Simon, Schwarz

    Leverkusen

  • Gemeinschaftspraxis Dres. Balck

    Meine

  • Praxis Dres. med. Naudts und Nowack

    Rodgau

Other trials in Germany

Netherlands3 sites

  • Meander Medisch Centrum Surgery

    Amersfoort

  • VU Medisch Centrum Gastroenterology

    Amsterdam

  • Ikazia ziekenhuis Gastroenterology

    Rotterdam

Other trials in Netherlands

United Kingdom1 site

  • Yeovil District Hospital NHS Trust Department of Surgery

    Yeovil

Other trials in United Kingdom

About this study

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

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.

Conditions
Diverticulitis
Being tested
Rifaximin delayed released 400mg Tablet, Placebo
Keywords
Recurrent acute diverticulitis, Prevention, Diverticular complications, Rifaximin delayed release, Diverticulitis, SIBO
Medical subject headings
Diverticulitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rifaximin delayed released 400mg TabletDrug

    Also called Rifaximin-EIR

    Rifaximin delayed released

  • PlaceboOther

    Placebo BID + Placebo BID

Study groups in NCT03469050
Study groupRoleWhat they receive
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
Receives: Drug: Rifaximin delayed released 400mg Tablet
Rifaximin delayed released 400 mg b.i.dExperimental(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
Receives: Drug: Rifaximin delayed released 400mg Tablet; Other: Placebo
Placebo b.i.d.Placebo comparator(i.e. 2 x placebo tablets twice a day) for 10 consecutive days a month, for 12 months.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12-month treatment period

Secondary outcomes (15)

  1. 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]

    Measured: 12-month treatment period

  2. Time to diverticulitis recurrence or complication

    Measured: 12-month treatment period

  3. Rate of patients with diverticulitis-associated fever

    Measured: 12-month treatment period

  4. Left-lower quadrant abdominal pain intensity

    Measured: 12-month treatment period

  5. Left-lower quadrant abdominal pain duration

    Measured: 12-month treatment period

  6. Number of days in a year with left-lower quadrant abdominal pain

    Measured: 12-month treatment period

  7. Number of weeks in a year with episodes of prolonged (≥24 hours) left-lower quadrant abdominal pain

    Measured: 12-month treatment period

  8. Number of days in a year with any abdominal pain

    Measured: 12-month treatment period

  9. Number of weeks in a year with bloating

    Measured: 12-month treatment period

  10. Change in bowel habits

    Evaluated by Bristol Stool Scale

    Measured: 12-month treatment period

  11. Rate of any hospitalization for diverticulitis

    Measured: 12-month treatment period

  12. Rate of hospitalization for diverticulitis without surgery

    Measured: 12-month treatment period

  13. Rate of elective surgery for diverticulitis

    Measured: 12-month treatment period

  14. Rate of emergency surgery for diverticulitis

    Measured: 12-month treatment period

  15. Change in Quality of Life

    Evaluated by SF36 Quality of Life Questionnaire

    Measured: 12-month treatment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2018
  2. Study start2 Jul 2018
  3. Primary completion22 Dec 2020
  4. Study completion22 Dec 2020

Why it stopped: Sponsor's decision

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
This study is a phase II, multicenter, double-blind, placebo-controlled, randomized clinical trial.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
193 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03469050
Sponsor's protocol ID
REDIV/002/17
Other IDs
2017-002708-28, 2017
Acronym
ROAD
Status last verified
Jul 2021
First submitted
6 Mar 2018
Last updated
20 Oct 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Rifaximin delayed released 400mg Tablet in people with Diverticulitis, run by Alfasigma S.p.A. at 64 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 64 sites in Italy, Spain, France, Germany, Netherlands and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Sponsor's decision). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of patients with recurrence of diverticulitis and/or diverticular complications over the 12-month treatment period. (time frame: 12-month treatment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03469050.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.

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