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.

Phase 1

• Conditions: Diverticulitis; MedDRA version: 9.1Level: LLTClassification code 10013538Term: Diverticulitis

• Registration Number: EUCTR2007-004895-37-FR
• Lead Sponsor: Shire Pharmaceutical Development Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2007-12-17
• Study Completion: 2012-03-05
• Last Update Posted: 18 October 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 584

Inclusion Criteria

To be eligible for inclusion, each subject must meet each of the following criteria at screening, and must continue to fulfil these criteria at baseline:
1. Written, signed, and dated informed consent to participate in the study must be given by the subject, in accordance with the International Conference on Harmonisation (ICH) Good Clinical Practice (GCP) Guideline E6 and applicable regulations, before completing any study-related procedures listed in Section 6.2.
2. Male and female subjects ³18 years of age
3. Males, or non-pregnant, non-lactating females of childbearing potential (FOCP), as demonstrated by negative beta HCG (human chorionic gonadotropin) serum pregnancy test, who agree to comply with any applicable contraceptive requirements of the protocol (refer to Section 4.4)
4. At least one documented attack of acute diverticulitis in the previous 24 months that has clinically resolved without colonic resection. (Documentation must include: physical examination, laboratory analysis, and a verifiable report confirming acute diverticulitis by CT scan, MRI scan, or endoscopy.)
5. Flexible sigmoidoscopy confirmation of diverticulosis with at least three diverticula noted. Frank ulceration and evidence of ischaemia is not acceptable. The presence of mild erythema and loss of vascularity (oedema) is not exclusionary
6. WBC count within normal reference ranges
7. Polymorphonuclear leukocyte [PMN] level within normal reference ranges
8. Subject and Investigator must agree that participation in this study is in the best interest of the subject

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subjects are excluded from the study if any of the following criteria are met at screening or at baseline:
1. History of complicated diverticular disease (peritoneal abscesses, surgical resection for diverticular stricture, active fistula disease), history of diverticular bleed or colonic stricture
2. Clinically relevant gross extraluminal pathology as shown by CT scan
3. Right sided diverticulosis only
4. Abdominal pain and abdominal tenderness upon palpation
5. Active peptic ulcer disease
6. History of or current presence of inflammatory bowel disease (IBD) or documented history of irritable bowel syndrome requiring regular monthly medication
7. Active GI bleeding, except for positive faecal occult blood test (FOBT) in the stool
8. Allergy or hypersensitivity to mesalazine (5-ASA) or aspirin
9. Subjects with asthma are excluded only if they are known to be mesalazine-sensitive
10. Allergy to radiologic contrast agents
11. Subjects must not have used another Investigational product within 30 days prior to Baseline
12. Use of antibiotic therapy within 4 weeks of Baseline
13. Use of prebiotic medication, or probiotic medication, as well as tegaserod, alosetron, laxatives, metaclopramide, domperidone, anti-spasmotic agents, and anti-diarrhoeal agents within 14 days of Baseline
14. Use of biologics (anti-TNF agents)
15. Use of immunomodulators (e.g., azathioprine, 6-mercaptopurine) within 6 weeks prior to Baseline
16. Use of systemic or rectal steroids within 6 weeks of Baseline
17. Subjects using any anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, COX-2 inhibitors, or ibuprofen on a regular basis (defined as over-the-counter NSAID use for 3 consecutive days or 7 occurrences per month, with the exception of aspirin [£325mg/day] taken for cardiac prophylaxis)
18. Subjects with clinically relevant moderate or severe renal or hepatic impairment are contraindicated with mesalazine products
19. Previous colorectal surgery (with the exception of haemorrhoidectomy, colonic removal of benign polyps, and appendectomy)
20. Current or relevant previous disease that could affect the colon, action, absorption, or disposition of the investigational product, or clinical or laboratory assessments
21. Malignancy, except for basal cell skin cancer, cervical carcinoma in-situ, or carcinoma in-situ in a colonoscopically removed polyp
22. Subjects with a history of alcohol or other substance abuse within the previous year
23. Current or relevant history of serious, severe, or unstable (acute of progressive) physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures
24. Subjects who have previously been screened for or enrolled into this study and subsequently withdrawn

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified