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Completed

NCT Number: NCT00545740

Prevention of Recurrence of Diverticulitis

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CIMEL, Lanus, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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
  • 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

Treatment and study plan

SPD476 (1.2g)

Drug

1.2g SPD476 once daily (QD) orally

Other names: Lialda, MMX™ mesalazine

SPD476 (2.4 g)

Drug

2.4g SPD476 QD orally

Other names: Lialda, MMX™ mesalazine

SPD476 (4.8 g)

Drug

4.8g SPD476 QD orally

Other names: Lialda, MMX™ mesalazine

Placebo

Drug

QD orally

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. Percent of Subjects Requiring Surgery for Diverticulitis

    Time frame: Up to 104 weeks

Sponsors and collaborators

Lead sponsor

Shire

Industry

Registry information

Official study 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.

Acronym: PREVENT1

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Oct 17, 2007
Registry last updated
Jun 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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