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DiverticulitisPhase 3PREVENT2NCT00545103

Prevention of Recurrence of Diverticulitis

A Phase 3 study testing SPD476, MMX™ mesalazine, 1.2g extended release tablet, SPD476, MMX™ mesalazine, 2.4g extended release tablet and SPD476, MMX™ mesalazine, 4.8g extended release tablet in people with Diverticulitis, run by Shire at 131 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diverticulitis
What is being tested?
SPD476, MMX™ mesalazine, 1.2g extended release tablet, SPD476, MMX™ mesalazine, 2.4g extended release tablet and SPD476, MMX™ mesalazine, 4.8g extended release tablet
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
592 participants
Where
131 sitesin 10 countries
Study dates
6 Dec 2007to 28 Nov 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females =>18yrs of age.
  • If female of childbearing potential (FOCP), has demonstrated a negative beta HCG (human chorionic gonadotropin) serum pregnancy test, and agrees to comply with any applicable contraceptive requirements of the protocol
  • An episode of acute diverticulitis that resolved without colonic resection.
  • Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon with at least three diverticula noted

Who cannot join

  • Previous colorectal surgery, including surgical intervention for diverticular disease (with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy)
  • Active peptic ulcer disease
  • History of or current presence of inflammatory bowel disease (IBD)
  • Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication
  • Allergy or hypersensitivity to aspirin or related compounds
  • Allergy to radiologic contrast agents
Show all 14Show fewer
  • Use of another Investigational product within 30 days of Baseline
  • Use of antibiotic therapy within 4 weeks of Baseline
  • Within 14 days of Baseline, use of prebiotic, probiotic or 5-ASA medications, as well as drugs active at the 5HT-receptor or anti-spasmodic agents
  • Use of systemic or rectal steroids within 6 weeks of Baseline. Use of inhaled or nasal steroids is acceptable
  • Use of anti-inflammatory drugs, (NSIADs, COX-2 inhibitors) including aspirin (except for cardiac prophylaxis) and ibuprofen, on a regular and ongoing basis
  • History of alcohol or other substance abuse within the previous year
  • Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to Baseline
  • Females who are lactating

Trial locations and contacts

131 sites in 10 countries.

131 sites in 10 countries

United States59 sites

  • Maryland Clinical Trials

    Annapolis, Maryland, 21401

  • Gastroenterology Associates, LLC

    Baton Rouge, Louisiana, 70809

  • Northwest Gastroenerology Associates

    Bellevue, Washington, 98004

  • Birmingham Gastroenterology Associates, PC

    Birmingham, Alabama, 35209

  • Alabama Clinical Therapeutics, LLC

    Birmingham, Alabama, 35235

  • Madeleine DuPree, MD

    Boynton Beach, Florida, 33426

  • Clinsearch, LLC

    Chattanooga, Tennessee, 37404

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45219

  • Gastrointestinal Clinical of Quad Cities

    Davenport, Iowa, 52807

  • Digestive Specialists Inc.

    Dayton, Ohio, 45415

  • Cumberland Research Associates

    Fayetteville, North Carolina, 28304

  • AMH Feasterville Family Health Care Center

    Feasterville, Pennsylvania, 19053

  • Digestive and Liver Disease Specialists

    Garden Grove, California, 92840

  • Memphis Gastroenterology Group, PC

    Germantown, Tennessee, 38138

  • LeBauer Research Associates, PA

    Greensboro, North Carolina, 27403

  • Palmetto Research LLC

    Hialeah, Florida, 33016

  • Mark Lamet, MD

    Hollywood, Florida, 33021

  • Mid Atlantic Medical Research Centers

    Hollywood, Maryland, 20636

  • Houston Endoscopy and Research Center

    Houston, Texas, 77024

  • Medical Affiliated Research Center, Inc

    Huntsville, Alabama, 35801

  • Alabama Digestive Disorders Center, PC

    Huntsville, Alabama, 35802

  • Gastrointestinal Associates, PA

    Jackson, Mississippi, 39202

  • Clinical Research of the Rockies

    Lafayette, Colorado, 80026

  • NY Center for Clinical Research

    Lake Success, New York, 11042

  • High Desert Gastroenterology, Inc.

    Lancaster, California, 93534

  • Arapahoe Gastroenterology, PC

    Littleton, Colorado, 80120

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

  • Charm City Research, LLC

    Lutherville, Maryland, 21093

  • Digestive Disease Consultants

    Maitland, Florida, 32751

  • Atlanta Gastroenterology Associates

    Marietta, Georgia, 30067

  • Center for Digestive & Liver Diseases, Inc

    Mexico, Missouri, 65265

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • University of Miami

    Miami, Florida, 33136

  • Miami Research Associates

    Miami, Florida, 33143

  • Sunflower Medical Group

    Mission, Kansas, 66202

  • Physician Research Options

    Murray, Utah, 84070

  • United Medical Research

    New Smyrna Beach, Florida, 32168

  • Concorde Medical Group

    New York, New York, 10016

  • CA Physicians Research Alliance

    Oceanside, California, 92083

  • Digestive Disorders Center

    Pittsburgh, Pennsylvania, 15213

  • Shah Associates, LLC

    Prince Frederick, Maryland, 20678

  • Wake Research Associates

    Raleigh, North Carolina, 27612

  • Hidalgo Clinical Research

    San Antonio, Texas, 78215

  • Digestive Care Medical Center

    San Carlos, California, 94070

  • Rider Research Group

    San Francisco, California, 94117

  • Huntington Medical Foundation

    San Marino, California, 91108

  • Granite Peaks Gastroenterology

    Sandy City, Utah, 84094

  • Seattle Gastroenterology Associates

    Seattle, Washington, 98133

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71103

  • Sundance Clinical Research

    St Louis, Missouri, 63141

  • West Wind'r Research & Development

    Tampa, Florida, 33607

  • Kansas Medical Clinic

    Topeka, Kansas, 66606

  • Litchfield County Gastroenterology Associates, LLC

    Torrington, Connecticut, 06790

  • Center for Digestive Health

    Troy, Michigan, 48098

  • Genova Clinical Research

    Tucson, Arizona, 85741

  • The Gastroenterology Group of South Jersey

    Vineland, New Jersey, 08360

  • Digestive Health Specialists

    Winston-Salem, North Carolina, 27103

Other trials in United States

South Africa12 sites

  • Universitas Hospital

    Bloemfontein, 9300

  • Panorama Medi-Clinic

    Cape Town, Western Cape, 7500

  • Harold Bloch

    Cape Town, 7130

  • Panorama Medi-Clinic

    Cape Town, 7500

  • Louis Leipoldt Medical Centre

    Cape Town, 7530

  • Kingsbury Hospital

    Cape Town, 7708

  • Parklands Medical Centre

    Durban, 4001

  • Chelmsford Medical Centre 2

    Durban

  • Milpark Hospital

    Johannesburg, 2006

  • Linksfield Park Clinic

    Johannesburg, 2192

  • Johannesburg General Hospital

    Johannesburg, 2193

  • Kloof Medi-Clinic

    Pretoria, 0143

Other trials in South Africa

Brazil10 sites

  • Unidade Integrada de Gastroenterologia UNIGASTRO

    Campinas, São Paulo, 13070-040

  • Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda.

    Goiânia, Goiás, 74535-170

  • Universidade Federal de Juiz de Fora

    Juiz de Fora, Minas Gerais, 36036-330

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Hospital Sao Lucas PUCRS

    Porto Alegre, Rio Grande do Sul, Porto Alegre

  • Hospital Universitário Clementino Fraga Filho

    Rio de Janeiro, Rio de Janeiro, 21.941-913

  • Hospital Universitario Pedro Ernesto

    Rio de Janeiro, 20551-030

  • Fundacao Universidade Federal do Rio Grande - Hopsital Universitario

    Rio Grande, Rio Grande do Sul, 96200-310

  • Irmandade da Santa Casa de Misericordia de Santos

    Santos, São Paulo, 11075-900

  • Centro de Pesquisas Clinicas- CPCLIN

    São Paulo, 01244-030

Other trials in Brazil

Canada9 sites

  • Corunna Medical Research Centre

    Corunna, Ontario, N0N 1G0

  • Hotel-Dieu de Levis

    Lévis, Quebec, G6V 3Z1

  • Omnispec Clinical Research

    Mirabel, Quebec, J7J 2K8

  • Hopital Maisonneuve-Rosemont

    Montreal, Quebec, H1T 2M4

  • Gastroenterology Centre

    Pointe-Claire, Quebec, H9R 3J1

  • Q&T Research

    Sherbrooke, Quebec, J1H4J6

  • Topsail Road Medical Clinic

    St. John's, Newfoundland and Labrador, A1E 2E2

  • Cleveland Clinic Canada

    Toronto, Ontario, M5J 2T3

  • Liver and Intestinal Research Centre

    Vancouver, British Columbia, V5Z 1H2

Other trials in Canada

Germany9 sites

  • Synexus ClinPharm GmbH Berlin

    Berlin, Berlin (Hellersdorf), 12627

  • Synexus ClinPharm International GmbH

    Bochum, 44787

  • Synexus ClinPharm International GmbH

    Frankfurt, 60596

  • Synexus ClinPharm International GmbH

    Görlitz, 02826

  • Gastrologische Gemeinschaftspraxis Herne im Ärztehaus am Evangelischen Krankenhaus Herne

    Herne, Nord-Rhein-Wesfalen, 44623

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105

  • Synexus ClinPharm International GmbH

    Leipzig, 04103

  • Synexus ClinPharm International GmbH

    Magdeburg, 39104

  • Synexus ClinPharm International GmbH

    Potsdam, 14467

Other trials in Germany

Italy9 sites

  • Ospedale Valduce

    Como, 22100

  • Ospedale Fatebenefratelli ed Oftalmico

    Milan, 20121

  • Universita degli Studi di Padova

    Padova, 35128

  • U.O. di Gastroenterologia ed Endoscopia digestiva Torre delle Medicine Azienda Ospedaliera di Parma

    Parma

  • Universita di Pavia Cattedra di Gastroenterologia Dipartimento di Medicina

    Pavia, 27100

  • Azienda Ospedaliera Universitaria Policlinico Tor Vergata

    Roma, 00133

  • San Camillo Forlanini

    Roma, 00151

  • Policlinico Univeritario A Gemelli

    Roma, 00168

  • Policlinico Univeritario A. Gemelli

    Roma, 00168

Other trials in Italy

Romania7 sites

  • Spitalul Clinic "Dr. I. Cantacuzino"

    Bucharest, 020475

  • Institutul Clinic Fundeni

    Bucharest, 022328

  • Spitalul Universitar de Urgenta Bucuresti

    Bucharest, 050098

  • CMI de Gastroenterologie Dobru Daniela

    Târgu Mureş, Mureș County, 540461

  • Centrul Medical Galenus

    Târgu Mureş, 540098

  • Cabinet Particular Policlinic Algomed SRL

    Timișoara, 300002

  • Policlinica "Dr. Citu" SRL

    Timișoara, 300593

Other trials in Romania

Hungary6 sites

  • Peterfy Hospital, Dept. Of Gastroenterology

    Budapest, H-1076

  • University of Debrecen, 3rd Dept. Of Medicine

    Debrecen, H-4032

  • Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium

    Gyula, H-5700

  • Kaposi Mór Teaching Hospital

    Kaposvár, H-7400

  • Karolina Hospital, Dept. of Internal Medicine and Gastroenterology

    Mosonmagyaróvár, 9200

  • Jávorszky Ödön Városi Kórhaz, II. Belgyógyászat

    Vác, 2600

Other trials in Hungary

Finland5 sites

  • Suomen Terveystalo Oyj

    Jyväskylä, 40100

  • Kuopio University Hospital

    Kuopio, 70211

  • Päijat-Häme Central Hospital

    Lahti, 15850

  • Oulu University Hospital

    Oulu, 90220

  • Vaasa Central Hospital

    Vaasa, 65130

Other trials in Finland

Netherlands5 sites

  • Meander Medisch Centrum

    Amersfoort, 3816

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • Academisch Ziekenhuis Maastricht

    Maastricht, 6202

  • Ikazia Ziekenhuis

    Rotterdam, 3083

  • St. Jans Gashuis

    Weert, 6001 BE

Other trials in Netherlands

About this study

Official title: A Phase III, Randomised, Double-Blind, Dose-Response, Stratified, Placebo-Controlled Study Evaluating the Safety and Efficacy of SPD476 Versus Placebo Over 104 Weeks in the Prevention of Recurrence of Diverticulitis.

The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.

Conditions
Diverticulitis
Being tested
SPD476, MMX™ mesalazine, 1.2g extended release tablet, SPD476, MMX™ mesalazine, 2.4g extended release tablet, SPD476, MMX™ mesalazine, 4.8g extended release tablet, Placebo
Medical subject headings
Diverticulitis

What participants receive

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

  • SPD476, MMX™ mesalazine, 1.2g extended release tabletDrug

    Also called LIALDA

    SPD476 1.2g administered Once Daily (QD)

  • SPD476, MMX™ mesalazine, 2.4g extended release tabletDrug

    Also called LIALDA

    SPD476 2.4g administered Once Daily (QD)

  • SPD476, MMX™ mesalazine, 4.8g extended release tabletDrug

    Also called LIALDA

    SPD476 4.8g administered Once Daily (QD)

  • PlaceboDrug

    Placebo administered Once Daily (QD)

Study groups in NCT00545103
Study groupRoleWhat they receive
SPD476 (1.2 g)ExperimentalNot described
Receives: Drug: SPD476, MMX™ mesalazine, 1.2g extended release tablet
SPD476 (2.4 g)ExperimentalNot described
Receives: Drug: SPD476, MMX™ mesalazine, 2.4g extended release tablet
SPD476 (4.8 g)ExperimentalNot described
Receives: Drug: SPD476, MMX™ mesalazine, 4.8g extended release tablet
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

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

  1. Percent of Subjects Without Recurrence of Diverticulitis

    Recurrence of diverticulitis is defined as the presence of each and all of the following 3 items: 1) abdominal pain, 2) a 15% increase in white blood cell count from baseline, 3) bowel wall thickening (>5 mm) and/or fat stranding as evidenced by spiral computerized axial tomography (CT) scan; OR surgical intervention for diverticular disease. Withdrawals are considered as recurrences.

    Measured: up to 104 Weeks

Secondary outcomes (6)

  1. Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis

    CT-recurrence of diverticulitis is defined as: a positive spiral CT scan for diverticulitis showing, at a minimum, fat stranding with or without bowel wall thickening >5 mm or surgical intervention for diverticular disease. Withdrawals considered as CT-recurrences.

    Measured: up to 104 weeks

  2. Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive

    A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.

    Measured: up to 104 Weeks

  3. Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative

    A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.

    Measured: up to 104 weeks

  4. Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive

    A positive CT scan was defined as a CT scan that showed bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.

    Measured: up to 104 weeks

  5. Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative

    A negative CT scan was defined as a CT scan that did not show bowel wall thickening (>5 mm) and/or fat stranding as read by the central reader.

    Measured: up to 104 weeks

  6. Percent of Subjects Requiring Surgery for Diverticulitis

    Measured: up to 104 Weeks

Timeline

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

  1. First posted17 Oct 2007 (estimated)
  2. Study start6 Dec 2007
  3. Primary completion28 Nov 2011
  4. Study completion28 Nov 2011

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 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
592 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00545103
Sponsor's protocol ID
SPD476-314
Other IDs
2007-004896-20
Acronym
PREVENT2
Status last verified
May 2021
First submitted
16 Oct 2007
Last updated
11 Jun 2021
Data monitoring committee
No

Publications

  • Raskin JB, Kamm MA, Jamal MM, Marquez J, Melzer E, Schoen RE, Szaloki T, Barrett K, Streck P. Mesalamine did not prevent recurrent diverticulitis in phase 3 controlled trials. Gastroenterology. 2014 Oct;147(4):793-802. doi: 10.1053/j.gastro.2014.07.004. Epub 2014 Jul 16.

    PubMed 25038431

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SPD476, MMX™ mesalazine, 1.2g extended release tablet, SPD476, MMX™ mesalazine, 2.4g extended release tablet and SPD476, MMX™ mesalazine, 4.8g extended release tablet in people with Diverticulitis, run by Shire at 131 sites in 10 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 14 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: finished, as of the sponsor's last update on 11 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 131 sites in United States, South Africa, Brazil, Canada, Germany and 5 more countries. 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 phase mean?

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?

Yes. Results are posted in the registry (first posted 19 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent of Subjects Without Recurrence of Diverticulitis (time frame: up to 104 Weeks). 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 NCT00545103, which also lists 1 linked publication.

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 11 Jun 2021.

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