Prevention of Recurrence of Diverticulitis (PREVENT1)

June 8, 2021 updated by: Shire

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.

Study Overview

Status

Status

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

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.
590

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 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

  • Argentina
      • Buenos Aires, Argentina, C1180AAX
        • Sanatorio Güemes
      • Buenos Aires, Argentina, B1657BHD
        • Hospital Bocalandro
      • Buenos Aires, Argentina, B1722FJN
        • Hospital Héroes de Malvinas
      • Buenos Aires, Argentina, C1117AAA
        • GEDYT
      • Santa Fe, Argentina, S2000BCG
        • Cibic S.A.
    • Buenos Aires
      • Lanus, Buenos Aires, Argentina, B1824KAS
        • CIMeL
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DFD
        • Instituto Gamma
  • Australia
      • Adelaide, Australia, 5000
        • Royal Adelaide Hospital
      • Camperdown, Australia, 2050
        • Royal Prince Albert Hospital
      • Frankston, Australia, 3199
        • Frankston Private
      • Frankston, Australia, VIC 3199
        • Bayside Gastroenterology
      • Fremantle, Australia, 6160
        • Fremantle Hospital
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • The Canberra Hospital
    • Victoria
      • Ballarat, Victoria, Australia, 3350
        • Ballarat Base Hospital
      • Melbourne, Victoria, Australia, 3065
        • St Vincent's Hospital (Melb) LTD
  • Colombia
      • Barranquilla, Colombia
        • Ugasend S.A
      • Bogota, Colombia
        • Hospital Universitario San Ignacio
      • Bogota, Colombia
        • Clinica Colsinatas SA
      • Bogota, Colombia
        • FOQUS, Centro de Investigacion Clinica
      • Bogota, Colombia
        • Fundación Clinica Abood Shaio
      • Medellin, Colombia
        • Clínica Las Américas
  • France
      • Lille, France, 59000
        • Cabinet du Dr Olivier Delette
      • Paris, France, 75017
        • Dr Michel Regensberg
    • Alsace
      • Strasbourg, Alsace, France, 67200
        • CHU de Strasbourg
    • Brittany
      • Nantes, Brittany, France, 44033
        • Hepato Gastro Enterology
    • Normandy
      • Rouen, Normandy, France, 76031
        • Hôpital Charles Nicolle
    • Paris
      • Clichy, Paris, France, 92118
        • Hôpital Beaujon
    • Picardie
      • Saint Quentin, Picardie, France, 02100
        • Cabinet de Gastro-enterologie du Dr Alain Thevenin
    • Provence-Alpes-Côte d'Azur
      • Nice, Provence-Alpes-Côte d'Azur, France, 06200
        • Hopital I'Archet
    • Provence-Alpes-Côte-d'Azur
      • Marseille, Provence-Alpes-Côte-d'Azur, France, 13000
        • Clinique Bouchard
    • Rhone-Alpes
      • Grenoble, Rhone-Alpes, France, 38043
        • CHU de Grenoble
  • India
      • Ahmedabad, India, 380006
        • Brahmin Mitra Mandal Society
      • Pune, India, 411 001
        • Ruby Hall Clinic
      • Secunderabad, India, 500 003
        • Krishna Institute of Medical Sciences
    • Kerala
      • Calicut, Kerala, India, 673004
        • Baby Memorial Hospital
      • Cochin, Kerala, India, 682304
        • Lakeshore Hospital & Research Centre Ltd
      • Trivandrum, Kerala, India, 695607
        • Sree Gokulam Medical College and Research Foundation
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Dayanand Medical College and Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India
        • S R Kalla Memorial Hospital
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600020
        • Aceer
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • Institute of Postgraduate Medical Education and Research
  • Israel
      • Afula, Israel, 18101
        • Emek medical center
      • Ashkelon, Israel, 78278
        • Barzilai Medical Centre
      • Beer Sheva, Israel, 84101
        • Soroka Medical Center
      • Haifa, Israel, 31048
        • Bnai Zion Medical Center
      • Haifa, Israel, 63106
        • Rambam Medical Center
      • Jerusalem, Israel
        • Hadassah Ein-Karem Medical Center
      • Kfar-Saba, Israel
        • Meir Medical Centre
      • Petah-Tikva, Israel, 49100
        • Rabin Medical Center
      • Rechovot, Israel
        • Kaplan Medical Center
      • Tel Aviv, Israel, 64239
        • The Tel Aviv Sourasky Medical Center
      • Tel Hashomer, Israel, 52621
        • The Chaim Sheba Medical Center
      • Zerifin, Israel, 70300
        • Assaf Harofeh Medical Center
  • New Zealand
      • Auckland, New Zealand
        • Auckland City Hospital
      • Christchurch, New Zealand
        • CURT Medical Trials Trust Board
      • Dunedin, New Zealand
        • Dunedin Hospital
      • Hamilton, New Zealand, 3240
        • Waikato Hospital
      • Tauranga, New Zealand
        • Tauranga Hospital
    • Auckland
      • Takapuna, Auckland, New Zealand
        • Shakespeare Specialist Group
  • Spain
      • Barcelona, Spain, 08035
        • Hospital Valle de Hebron
      • Barcelona, Spain, 08907
        • Hospital Universitario de Bellvitge
      • Palma de Mallorca, Spain, 07014
        • Hospital Son Dureta
      • San Sebastian, Spain, 20014
        • Hospital de Donostia
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
  • Sweden
      • Goteborg, Sweden, 41685
        • University Hospital/Eastern Hospital
      • Linköping, Sweden, 58185
        • University Hospital Linköping
      • Stockholm, Sweden, 18288
        • Danderyd Hospital
      • Stockholm, Sweden, 17176
        • Karolinska University Hospital
      • Stockholm, Sweden, 11883
        • VO Internmedicin
      • Uppsala, Sweden
        • Kirurgkliniken
  • United Kingdom
      • London, United Kingdom, SE5 9RS
        • King's College Hospital
      • London, United Kingdom, SW10 9NH
        • Chelsea & Westminster Hospital
      • London, United Kingdom, W12 0NN
        • Imperial College London
    • East Anglia
      • Norwich, East Anglia, United Kingdom, NR4 7UY
        • Norfolk/Norwich University Hospital
    • London
      • Harrow, London, United Kingdom, HA1 3UJ
        • St Mark's Hospital
  • United States
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • Dedicated Clinical Research
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Lynn Institute of the Ozarks
    • California
      • Anaheim, California, United States, 92108
        • Advanced Clinical Research Institute
      • Chula Vista, California, United States, 91910
        • GW Research
      • Monterey, California, United States, 93940
        • Monterey Bay GI Research Institute, Inc
      • Rancho Cucamonga, California, United States, 91730
        • Rancho Cucamonga C. Trials
      • Roseville, California, United States, 95661
        • Clinical Trials Research
      • San Diego, California, United States, 92123
        • Medical Associates Research
      • Torrance, California, United States, 90505
        • Torrance Clinical Research
    • Colorado
      • Thornton, Colorado, United States, 80229
        • Rocky Mountain Gastroenterology Associates
    • Connecticut
      • Bridgeport, Connecticut, United States, 06606
        • Gastroenterology Associates of Fairfield County
      • New Haven, Connecticut, United States, 06520
        • Yale Center for Clinical Investigation
    • Florida
      • Boynton Beach, Florida, United States, 33472
        • Zasa Clinical Research
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc.
      • Jacksonville, Florida, United States, 32256
        • Borland-Groover Clinic
      • Orlando, Florida, United States, 32806
        • Compass Research
      • Port Orange, Florida, United States, 32129
        • Accord Clinic Research, LLC
      • Tampa, Florida, United States, 33613
        • Florida Medical Clinic/Tampa Clinical Trials
    • Georgia
      • Macon, Georgia, United States, 31201
        • Gastroenterology Associates Of Central Georgia, LLC
    • Indiana
      • Anderson, Indiana, United States, 46016
        • Saint John's Research Institute
    • Iowa
      • Clive, Iowa, United States, 50325
        • Digestive & Liver Disease Consultants
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • New Orleans Research Institute
    • Maryland
      • Baltimore, Maryland, United States, 21229
        • Digestive Disease Associates
      • Towson, Maryland, United States, 21204
        • Endoscopic Microsurgery Associates, PA
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Borgess Research Institute
    • Missouri
      • Jefferson City, Missouri, United States, 65109
        • Jefferson City Medical Group
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • South Jersey Gastroenterology, P.A.
      • Ocean City, New Jersey, United States, 07712
        • Howard Guss, DO
      • Passaic, New Jersey, United States, 07055
        • New Jersey Physicians, LLC
      • Voorhees, New Jersey, United States, 08043
        • Allied Gastrointestinal Associates, P.A.
    • New York
      • Endwell, New York, United States, 13760
        • Regional Clinical Research
      • Great Neck, New York, United States, 11021
        • Long Island Clinical Research Associates
      • Great Neck, New York, United States, 11023
        • Long Island Gastrointestinal Research Group
      • New York, New York, United States, 10075
        • Research Associates of New York
    • North Carolina
      • Greensboro, North Carolina, United States, 27408
        • Vital Research
    • Ohio
      • Canton, Ohio, United States, 44718
        • Gastroenterology Specialists, Inc
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Memorial Research Center
      • Kingsport, Tennessee, United States, 37660
        • Gastroenterology Associates Clinical Research
      • Nashville, Tennessee, United States, 37205
        • Nashville Medical Research Institute
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Harris Methodist Fort Worth Hospital
      • Houston, Texas, United States, 77005
        • Kelsey-Seybold Clinic
      • San Antonio, Texas, United States, 78229
        • Clinical Trials of Texas, Inc.
      • San Antonio, Texas, United States, 78258
        • Stone Oak Research Foundation
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Blue Ridge Medical Research
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53209
        • Aurora Advanced Healthcare, Inc. - Clinical Research Center

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Males and females =>18yrs of age.
  2. 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.
  3. An episode of acute diverticulitis that resolved without colonic resection.
  4. Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon with at least three diverticula noted.

Exclusion Criteria:

  1. Previous colorectal surgery, including surgical intervention for diverticular disease (with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy)
  2. Active peptic ulcer disease
  3. History of or current presence of inflammatory bowel disease (IBD)
  4. Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication
  5. Allergy or hypersensitivity to aspirin or related compounds
  6. Allergy to radiologic contrast agents
  7. Use of another Investigational product within 30 days of Baseline
  8. Use of antibiotic therapy within 4 weeks of Baseline
  9. 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
  10. Use of systemic or rectal steroids within 6 weeks of Baseline. Use of inhaled or nasal steroids is acceptable
  11. Use of anti-inflammatory drugs, (NSIADs, COX-2 inhibitors) including aspirin (except for cardiac prophylaxis) and ibuprofen, on a regular and ongoing basis
  12. History of alcohol or other substance abuse within the previous year
  13. Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to Baseline
  14. Females who are lactating

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
  • 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.
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
QD orally
EXPERIMENTAL: SPD476 (1.2 g)
Drug: SPD476 (1.2g)
1.2g SPD476 once daily (QD) orally
Other Names:
  • Lialda, MMX™ mesalazine
EXPERIMENTAL: SPD476 (2.4 g)
Drug: SPD476 (2.4 g)
2.4g SPD476 QD orally
Other Names:
  • Lialda, MMX™ mesalazine
EXPERIMENTAL: SPD476 (4.8 g)
Drug: SPD476 (4.8 g)
4.8g SPD476 QD orally
Other Names:
  • Lialda, MMX™ mesalazine

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
Measure Description
Time Frame
Percent of Subjects Without Recurrence of Diverticulitis
Time Frame: Up to 104 weeks
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.
Up to 104 weeks

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
Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis
Time Frame: Up to 104 weeks
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.
Up to 104 weeks
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive
Time Frame: Up to 104 weeks
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.
Up to 104 weeks
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative
Time Frame: Up to 104 weeks
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.
Up to 104 weeks
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive
Time Frame: Up to 104 weeks
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.
Up to 104 weeks
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative
Time Frame: Up to 104 weeks
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.
Up to 104 weeks
Percent of Subjects Requiring Surgery for Diverticulitis
Time Frame: Up to 104 weeks
Up to 104 weeks

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.
Shire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
November 28, 2007

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.
March 5, 2012

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.
March 5, 2012

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).
October 16, 2007

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.
October 16, 2007

First Posted (ESTIMATE)

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.
October 17, 2007

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.
June 14, 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.
June 8, 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.
June 1, 2021

More Information

Terms related to this study

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.
  • SPD476-313
  • 2007-004895-37 (EUDRACT_NUMBER)

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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