AzTrials
AzTrials

DiverticulitisPhase 3PREVENT1NCT00545740

Prevention of Recurrence of Diverticulitis

A Phase 3 study testing SPD476 (1.2g), SPD476 (2.4 g) and SPD476 (4.8 g) in people with Diverticulitis, run by Shire at 121 sites in 11 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 (1.2g), SPD476 (2.4 g) and SPD476 (4.8 g)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
590 participants
Where
121 sitesin 11 countries
Study dates
28 Nov 2007to 5 Mar 2012
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

121 sites in 11 countries.

121 sites in 11 countries

United States46 sites

  • Advanced Clinical Research Institute

    Anaheim, California, 92108

  • Saint John's Research Institute

    Anderson, Indiana, 46016

  • Digestive Disease Associates

    Baltimore, Maryland, 21229

  • ZASA Clinical Research

    Boynton Beach, Florida, 33472

  • Gastroenterology Associates of Fairfield County

    Bridgeport, Connecticut, 06606

  • Gastroenterology Specialists, Inc

    Canton, Ohio, 44718

  • Memorial Research Center

    Chattanooga, Tennessee, 37404

  • GW Research

    Chula Vista, California, 91910

  • Clinical Research of West Florida, Inc.

    Clearwater, Florida, 33765

  • Digestive & Liver Disease Consultants

    Clive, Iowa, 50325

  • Regional Clinical Research

    Endwell, New York, 13760

  • Harris Methodist Fort Worth Hospital

    Fort Worth, Texas, 76104

  • Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • Long Island Gastrointestinal Research Group

    Great Neck, New York, 11023

  • Vital Research

    Greensboro, North Carolina, 27408

  • Kelsey-Seybold Clinic

    Houston, Texas, 77005

  • Borland-Groover Clinic

    Jacksonville, Florida, 32256

  • Jefferson City Medical Group

    Jefferson City, Missouri, 65109

  • Borgess Research Institute

    Kalamazoo, Michigan, 49048

  • Gastroenterology Associates Clinical Research

    Kingsport, Tennessee, 37660

  • Dedicated Clinical Research

    Litchfield Park, Arizona, 85340

  • Lynn Institute of the Ozarks

    Little Rock, Arkansas, 72205

  • Blue Ridge Medical Research

    Lynchburg, Virginia, 24502

  • Gastroenterology Associates of Central Georgia, LLC

    Macon, Georgia, 31201

  • South Jersey Gastroenterology, P.A.

    Marlton, New Jersey, 08053

  • New Orleans Research Institute

    Metairie, Louisiana, 70006

  • Aurora Advanced Healthcare, Inc. - Clinical Research Center

    Milwaukee, Wisconsin, 53209

  • Monterey Bay GI Research Institute, Inc

    Monterey, California, 93940

  • Nashville Medical Research Institute

    Nashville, Tennessee, 37205

  • Yale Center for Clinical Investigation

    New Haven, Connecticut, 06520

  • Research Associates of New York

    New York, New York, 10075

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Howard Guss, DO

    Ocean City, New Jersey, 07712

  • Compass Research

    Orlando, Florida, 32806

  • New Jersey Physicians, LLC

    Passaic, New Jersey, 07055

  • Accord Clinic Research, LLC

    Port Orange, Florida, 32129

  • Rancho Cucamonga C. Trials

    Rancho Cucamonga, California, 91730

  • Clinical Trials Research

    Roseville, California, 95661

  • Clinical Trials of Texas, Inc.

    San Antonio, Texas, 78229

  • Stone Oak Research Foundation

    San Antonio, Texas, 78258

  • Medical Associates Research

    San Diego, California, 92123

  • Florida Medical Clinic/Tampa Clinical Trials

    Tampa, Florida, 33613

  • Rocky Mountain Gastroenterology Associates

    Thornton, Colorado, 80229

  • Torrance Clinical Research

    Torrance, California, 90505

  • Endoscopic Microsurgery Associates, PA

    Towson, Maryland, 21204

  • Allied Gastrointestinal Associates, P.A.

    Voorhees Township, New Jersey, 08043

Other trials in United States

Israel12 sites

  • Emek Medical Center

    Afula, 18101

  • Barzilai Medical Centre

    Ashkelon, 78278

  • Soroka Medical Center

    Beersheba, 84101

  • Bnai Zion Medical Center

    Haifa, 31048

  • Rambam Medical Center

    Haifa, 63106

  • Hadassah Ein-Karem Medical Center

    Jerusalem

  • Meir Medical Centre

    Kfar Saba

  • Rabin Medical Center

    Petah Tikva, 49100

  • Kaplan Medical Center

    Rehovot

  • The Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

  • The Chaim Sheba Medical Center

    Tel HaShomer, 52621

  • Assaf Harofeh Medical Center

    Tsrifin, 70300

Other trials in Israel

France10 sites

  • Hopital Beaujon

    Clichy, Paris, 92118

  • CHU de Grenoble

    Grenoble, Auvergne-Rhône-Alpes, 38043

  • Cabinet du Dr Olivier Delette

    Lille, 59000

  • Clinique Bouchard

    Marseille, Provence-Alpes-Côte d'Azur Region, 13000

  • Hepato Gastro Enterology

    Nantes, Brittany Region, 44033

  • Hopital I'Archet

    Nice, Provence-Alpes-Côte d'Azur Region, 06200

  • Dr Michel Regensberg

    Paris, 75017

  • Hopital Charles Nicolle

    Rouen, Normandy, 76031

  • Cabinet de Gastro-enterologie du Dr Alain Thevenin

    Saint-Quentin, Picardie, 02100

  • CHU de Strasbourg

    Strasbourg, Alsace, 67200

Other trials in France

India10 sites

  • Brahmin Mitra Mandal Society

    Ahmedabad, 380006

  • Baby Memorial Hospital

    Calicut, Kerala, 673004

  • Aceer

    Chennai, Tamil Nadu, 600020

  • S R Kalla Memorial Hospital

    Jaipur, Rajasthan

  • Lakeshore Hospital & Research Centre Ltd

    Kochi, Kerala, 682304

  • Institute of Postgraduate Medical Education and Research

    Kolkata, West Bengal, 700020

  • Dayanand Medical College and Hospital

    Ludhiana, Punjab, 141001

  • Ruby Hall Clinic

    Pune, 411 001

  • Krishna Institute of Medical Sciences

    Secunderabad, 500 003

  • Sree Gokulam Medical College and Research Foundation

    Trivandrum, Kerala, 695607

Other trials in India

Australia8 sites

  • Royal Adelaide Hospital

    Adelaide, 5000

  • Ballarat Base Hospital

    Ballarat, Victoria, 3350

  • Royal Prince Albert Hospital

    Camperdown, 2050

  • Frankston Private

    Frankston, 3199

  • Bayside Gastroenterology

    Frankston, VIC 3199

  • Fremantle Hospital

    Fremantle, 6160

  • The Canberra Hospital

    Garran, Australian Capital Territory, 2605

  • St Vincent's Hospital (Melb) LTD

    Melbourne, Victoria, 3065

Other trials in Australia

Argentina7 sites

  • Hospital Bocalandro

    Buenos Aires, B1657BHD

  • Hospital Heroes de Malvinas

    Buenos Aires, B1722FJN

  • GEDYT

    Buenos Aires, C1117AAA

  • Sanatorio Guemes

    Buenos Aires, C1180AAX

  • CIMEL

    Lanus, Buenos Aires, B1824KAS

  • Instituto Gamma

    Rosario, Santa Fe Province, S2000DFD

  • Cibic S.A.

    Santa Fe, S2000BCG

Other trials in Argentina

Colombia6 sites

  • Ugasend S.A

    Barranquilla

  • Clinica Colsinatas SA

    Bogotá

  • FOQUS, Centro de Investigacion Clinica

    Bogotá

  • Fundacion Clinica Abood Shaio

    Bogotá

  • Hospital Universitario San Ignacio

    Bogotá

  • Clinica Las Americas

    Medellín

Other trials in Colombia

New Zealand6 sites

  • Auckland City Hospital

    Auckland

  • CURT Medical Trials Trust Board

    Christchurch

  • Dunedin Hospital

    Dunedin

  • Waikato Hospital

    Hamilton, 3240

  • Shakespeare Specialist Group

    Takapuna, Auckland

  • Tauranga Hospital

    Tauranga

Other trials in New Zealand

Sweden6 sites

  • University Hospital/Eastern Hospital

    Gothenburg, 41685

  • University Hospital Linköping

    Linköping, 58185

  • VO Internmedicin

    Stockholm, 11883

  • Karolinska University Hospital

    Stockholm, 17176

  • Danderyd Hospital

    Stockholm, 18288

  • Kirurgkliniken

    Uppsala

Other trials in Sweden

Spain5 sites

  • Hospital Valle de Hebron

    Barcelona, 08035

  • Hospital Universitario de Bellvitge

    Barcelona, 08907

  • Hospital de Donostia

    Donostia / San Sebastian, 20014

  • Hospital Son Dureta

    Palma de Mallorca, 07014

  • Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

United Kingdom5 sites

  • St Mark's Hospital

    Harrow, London, HA1 3UJ

  • King's College Hospital

    London, SE5 9RS

  • Chelsea & Westminster Hospital

    London, SW10 9NH

  • Imperial College London

    London, W12 0NN

  • Norfolk/Norwich University Hospital

    Norwich, East Anglia, NR4 7UY

Other trials in United Kingdom

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 (1.2g), SPD476 (2.4 g), SPD476 (4.8 g), 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 (1.2g)Drug

    Also called Lialda, MMX™ mesalazine

    1.2g SPD476 once daily (QD) orally

  • SPD476 (2.4 g)Drug

    Also called Lialda, MMX™ mesalazine

    2.4g SPD476 QD orally

  • SPD476 (4.8 g)Drug

    Also called Lialda, MMX™ mesalazine

    4.8g SPD476 QD orally

  • PlaceboDrug

    QD orally

Study groups in NCT00545740
Study groupRoleWhat they receive
SPD476 (1.2 g)ExperimentalNot described
Receives: Drug: SPD476 (1.2g)
SPD476 (2.4 g)ExperimentalNot described
Receives: Drug: SPD476 (2.4 g)
SPD476 (4.8 g)ExperimentalNot described
Receives: Drug: SPD476 (4.8 g)
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 Were 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 start28 Nov 2007
  3. Primary completion5 Mar 2012
  4. Study completion5 Mar 2012

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
590 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00545740
Sponsor's protocol ID
SPD476-313
Other IDs
2007-004895-37
Acronym
PREVENT1
Status last verified
Jun 2021
First submitted
16 Oct 2007
Last updated
14 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 (1.2g), SPD476 (2.4 g) and SPD476 (4.8 g) in people with Diverticulitis, run by Shire at 121 sites in 11 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 14 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 121 sites in United States, Israel, France, India, Australia and 6 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 25 Jan 2013). 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 NCT00545740, 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 14 Jun 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in