Phase 3 N=590 Randomized Quadruple-blind Prevention

Prevention of Recurrence of Diverticulitis

Diverticulitis

Bottom Line

View on ClinicalTrials.gov: NCT00545740 ↗

Enrolled (actual)

590

Serious AEs

11.2%

Results posted

Jan 2013

Primary outcome: Primary: Percent of Subjects Without Recurrence of Diverticulitis — 62.2; 62.9; 52.7; 64.6 percentage of subjects — p=0.047

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: SPD476 (1.2g) (Drug); SPD476 (2.4 g) (Drug); SPD476 (4.8 g) (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Shire
Primary completion: Mar 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent of Subjects Without Recurrence of Diverticulitis	62.2; 62.9; 52.7; 64.6	0.047 sig
SECONDARY Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis	61.5; 62.2; 52.7; 63.9	0.063
SECONDARY Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive	37; 39; 55; 38; 30; 39	—
SECONDARY Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative	19; 10; 5; 10; 19; 8	—
SECONDARY Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive	0; 0; 1; 1; 0; 0	—
SECONDARY Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative	0; 3; 2; 3; 0; 2	—
SECONDARY Percent of Subjects Requiring Surgery for Diverticulitis	2.8; 2.8; 3.3; 2.0	—

Summary

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

Eligibility Criteria

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

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Data sourced from ClinicalTrials.gov (NCT00545740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.