Prevention of Recurrence of Diverticulitis (PREVENT1)
This study has been completed.
Sponsor:
Shire Development LLC
Information provided by (Responsible Party):
Shire Development LLC
ClinicalTrials.gov Identifier:
NCT00545740
First received: October 16, 2007
Last updated: February 1, 2013
Last verified: February 2013
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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 Development LLC:
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:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00545740
Show 121 Study Locations
Show 121 Study LocationsSponsors and Collaborators
Shire Development LLC
Investigators
| Principal Investigator: | Prof. Michael Kamm | St. Vincent’s Hospital. |
More Information
No publications provided
| Responsible Party: | Shire Development LLC |
| ClinicalTrials.gov Identifier: | NCT00545740 History of Changes |
| Other Study ID Numbers: | SPD476-313 |
| Study First Received: | October 16, 2007 |
| Results First Received: | December 19, 2012 |
| Last Updated: | February 1, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diverticulitis Recurrence 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 May 19, 2013