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In This Section Texas Health Research & Education Institute

Clinical Trials

Disease or Condition   Diverticulitis
Title   Prevention of Recurrence of Diverticulitis (PREVENT 1)
Description   The purpose of this study is to determine whether SPD476 (an investigational medicine) is effective in reducing recurrence of diverticulitis.
IRB Number   Pro269
Inclusion/Notes   INCLUSION:
  • Males and females at least 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:
  • 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.
Status   Completed
Location   Texas Health Harris Methodist Fort Worth
Principal Name    Kumar G Gutta MD
Contact Name   Anne Gilbert
Phone   (817) 820-4964

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