Phase 3
N=592
Prevention of Recurrence of Diverticulitis
Diverticulitis
Bottom Line
View on ClinicalTrials.gov: NCT00545103 ↗Enrolled (actual)
592
Serious AEs
8.7%
Results posted
Dec 2012
Primary outcome: Primary: Percent of Subjects Without Recurrence of Diverticulitis — 62.8; 59.2; 69.1; 67.6 percentage of subjects — p=0.778
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SPD476, MMX™ mesalazine, 1.2g extended release tablet (Drug); SPD476, MMX™ mesalazine, 2.4g extended release tablet (Drug); SPD476, MMX™ mesalazine, 4.8g extended release tablet (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Shire
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Subjects Without Recurrence of Diverticulitis |
62.8; 59.2; 69.1; 67.6 | 0.778 |
| SECONDARY Percent of Subjects Who Are CT-Recurrence Free of Diverticulitis |
62.8; 59.2; 69.1; 66.9 | 0.685 |
| SECONDARY Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive |
49; 45; 35; 30; 48; 39 | — |
| SECONDARY Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative |
9; 8; 22; 15; 8; 6 | — |
| 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 |
1; 0; 0; 0; 1; 0 | — |
| SECONDARY Percent of Subjects Requiring Surgery for Diverticulitis |
4.7; 2.7; 2.0; 1.4 | — |
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
Data sourced from ClinicalTrials.gov (NCT00545103). 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.