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

• Conditions: Treatment of Diverticulitis; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]; MedDRA version: 13.1Level: PTClassification code 10013538Term: DiverticulitisSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2007-004896-20-NL
• Lead Sponsor: Shire Pharmaceutical Development Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-01
• Last Update Posted: 11 September 2012

Recruitment & Eligibility

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

Inclusion Criteria

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 6.1.
2. Male and female subjects =18 years of age.
3. 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 (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 a verifiable report confirming acute diverticulitis (examples include CT scan, magnetic resonance imaging (MRI) scan, ultrasound, endoscopy of the sigmoid colon, or barium enema).
5. Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon, with at least three diverticula noted. The presence of mild erythema and loss of vascularity (oedema) is acceptable, whereas frank ulceration and evidence of ischaemia is not.
6. White Blood Cell (WBC) count within central laboratory normal reference ranges.
7. Polymorphonuclear leukocyte (PMN) level within central laboratory 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0
;
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 6.1.
2. Male and female subjects =18 years of age.
3. 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 (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 a verifiable report confirming acute diverticulitis (examples include CT scan, magnetic resonance imaging (MRI) scan, ultrasound, endoscopy of the sigmoid colon, or barium enema).
5. Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon, with at least three diverticula noted. The presence of mild erythema and loss of vascularity (oedema) is acceptable, whereas frank ulceration and evidence of ischaemia is not.
6. White Blood Cell (WBC) count within central laboratory normal reference ranges.
7. Polymorphonuclear leukocyte (PMN) level within central laboratory 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

1. Subjects who have had an attack of diverticulitis and/or continue to exhibit signs and symptoms of diverticulitis within 6 weeks prior to and up to Baseline
2. Previous colorectal surgery, including surgical intervention for diverticular disease (with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy)
3. Clinically relevant gross extraluminal pathology as shown by CT scan
4. Right sided diverticulosis only
5. Active peptic ulcer disease
6. History of or current presence of inflammatory bowel disease (IBD)
7. Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication.
8. Active GI bleeding, except for positive faecal occult blood test (FOBT) in the stool
9. Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to Baseline
10. Allergy or hypersensitivity to mesalazine (5-ASA) or aspirin
11. Subjects who are unwilling or unable to undergo a CT scan or have a known or suspected allergy to all radiologic contrast agents.
12. Subjects must not have used another investigational product within 30 days prior to Baseline
13. Within 14 days of Baseline, use of prebiotic, probiotic or 5-ASA medications, as well as drugs active at the 5HT-receptor (e.g., tegaserod, alosetron, metaclopramide) or anti-spasmodic agents
14. Any current or historical 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. Use of inhaled or nasal steroids is acceptable
17. Subjects who have conditions requiring regular and ongoing use of anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, COX 2 inhibitors, or ibuprofen. Use of aspirin (=325mg/day) taken for cardiac prophylaxis is acceptable
18. Subjects with clinically relevant moderate or severe renal or hepatic impairment are contraindicated with mesalazine products
19. Current or relevant previous disease that could affect the colon, action, absorption, or disposition of the investigational product, or clinical or laboratory assessments.
20. Any history of malignancy, except for basal cell skin cancer, cervical carcinoma in-situ, or carcinoma in-situ in a colonoscopically removed polyp
21. Subjects with a history of alcohol or other substance abuse within the previous year
22. Females who are lactating
23. Current or relevant history of serious, severe, or unstable (acute or 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

;
1. Subjects who have had an attack of diverticulitis and/or continue to exhibit signs and symptoms of diverticulitis within 6 weeks prior to and up to Baseline
2. Previous colorectal surgery, including surgical intervention for diverticular disease (with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy)
3. Clinically relevant gross extraluminal pathology as shown by CT scan
4. Right sided diverticulosis only
5. Active peptic ulcer disease
6. History of or current presence of inflammatory bowel disease (IBD)
7. Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication.
8. Active GI bleeding, except for positive faecal occult blood test (FOBT) in the stool
9. Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to Baseline
10. Allergy or hypersensitivity to mesalazine (5-ASA) or aspirin
11. Subjects who are unwilling or unable to undergo a CT scan or have a known or suspected allergy to all radiologic contrast agents.
12. Subjects must not have used another investigational product within 30 days prior to Baseline
13. Within 14 days of Baseline, use of prebiotic, probiotic or 5-ASA medications, as well as drugs active at the 5HT-receptor (e.g., tegaserod, alosetron, metaclopramide) or anti-spasmodic agents
14. Any current or historical 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. Use of inhaled or nasal steroids is acceptable
17. Subjects who have conditions requiring regular and ongoing use of anti-inflammatory drugs, including non-steroidal anti-inflammatory drugs (NSAIDs), such as aspirin, COX 2 inhibitors, or ibuprofen. Use of aspirin (=325mg/day) taken for cardiac prophylaxis is acceptable
18. Subjects with clinically relevant moderate or severe renal or hepatic impairment are contraindicated with mesalazine products
19. Current or relevant previous disease that could affect the colon, action, absorption, or disposition of the investigational product, or clinical or laboratory assessments.
20. Any history of malignancy, except for basal cell skin cancer, cervical carcinoma in-situ, or carcinoma in-situ in a colonoscopically removed polyp
21. Subjects with a history of alcohol or other substance abuse within the previous year
22. Females who are lactating
23. Current or relevant history of serious, severe, or unstable (acute or 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