Prevention of Recurrence of Diverticulitis (PREVENT1)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT00545740
First received: October 16, 2007
Last updated: June 6, 2014
Last verified: February 2013
  Purpose

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


Condition Intervention Phase
Diverticulitis
Drug: SPD476 (1.2g)
Drug: SPD476 (2.4 g)
Drug: SPD476 (4.8 g)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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.

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Percent of Subjects Without Recurrence of Diverticulitis [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: No ]
    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.

  • Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: No ]
    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.

  • Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: No ]
    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.

  • Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: No ]
    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.

  • Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: No ]
    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.

  • Percent of Subjects Requiring Surgery for Diverticulitis [ Time Frame: Up to 104 weeks ] [ Designated as safety issue: No ]

Enrollment: 590
Study Start Date: November 2007
Study Completion Date: March 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SPD476 (1.2 g) Drug: SPD476 (1.2g)
1.2g SPD476 once daily (QD) orally
Other Name: Lialda, MMX™ mesalazine
Experimental: SPD476 (2.4 g) Drug: SPD476 (2.4 g)
2.4g SPD476 QD orally
Other Name: Lialda, MMX™ mesalazine
Experimental: SPD476 (4.8 g) Drug: SPD476 (4.8 g)
4.8g SPD476 QD orally
Other Name: Lialda, MMX™ mesalazine
Placebo Comparator: Placebo Drug: Placebo
QD orally

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00545740

  Show 121 Study Locations
Sponsors and Collaborators
Shire
Investigators
Principal Investigator: Prof. Michael Kamm St. Vincent’s Hospital.
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT00545740     History of Changes
Other Study ID Numbers: SPD476-313, 2007-004895-37
Study First Received: October 16, 2007
Results First Received: December 19, 2012
Last Updated: June 6, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Diverticulitis
Recurrence
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Disease Attributes
Pathologic Processes
Mesalamine
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014