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Prevention of Recurrence of Diverticulitis (PREVENT 2)
This study is currently recruiting participants.
Verified by Shire Pharmaceutical Development, October 2008
Sponsored by: Shire Pharmaceutical Development
Information provided by: Shire Pharmaceutical Development
ClinicalTrials.gov Identifier: NCT00545103
  Purpose

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


Condition Intervention Phase
Diverticulitis
Drug: SPD476, MMX™ mesalazine, 1.2g extended release tablet
Drug: Placebo
Phase III

MedlinePlus related topics: Diverticulosis and Diverticulitis
Drug Information available for: Mesalamine
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy 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.

Further study details as provided by Shire Pharmaceutical Development:

Primary Outcome Measures:
  • Changes in predefined lab parameters [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]
  • Time to presence of predefined symptoms of diverticulitis [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of subjects without recurrence of diverticulitis between 3 doses of SPD476 and placebo [ Time Frame: 26 and 52 Weeks ] [ Designated as safety issue: No ]
  • Evaluate the subgroup classifications of diverticulitis between 3 doses of SPD476 and placebo [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects requiring surgical intervention for diverticular disease up to 104 weeks post baseline between 3 doses of SPD476 and placebo [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]
  • Quality of Life (QoL)questionnaires between treatment groups [ Time Frame: Baseline, 16, 52 and 104 Weeks ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability of SPD476 at 3 different doses [ Time Frame: 104 Weeks ] [ Designated as safety issue: Yes ]
  • Endoscopy of the sigmoid colon between treatment groups [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]
  • Histology of biopsy samples between treatment groups [ Time Frame: 104 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 584
Study Start Date: December 2007
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: SPD476, MMX™ mesalazine, 1.2g extended release tablet
SPD476 1.2g administered Once Daily (QD)
2: Experimental Drug: SPD476, MMX™ mesalazine, 1.2g extended release tablet
SPD476 2.4g administered Once Daily (QD)
3: Experimental Drug: SPD476, MMX™ mesalazine, 1.2g extended release tablet
SPD476 4.8g administered Once Daily (QD)
4: Placebo Comparator Drug: Placebo
Placebo

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545103

Contacts
Contact: Shire Call Centre +1 866 842 5335

  Show 71 Study Locations
Sponsors and Collaborators
Shire Pharmaceutical Development
Investigators
Principal Investigator: Jeffrey B. Raskin, M.D. University of Miami Miller School of Medicine
  More Information

Responsible Party: Shire ( Timothy Whitaker, M.D. )
Study ID Numbers: SPD476-314
Study First Received: October 16, 2007
Last Updated: October 3, 2008
ClinicalTrials.gov Identifier: NCT00545103  
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Diverticulitis
Mesalamine
Recurrence

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Pathologic Processes
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Central Nervous System Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009