Diverticulitis
Conditions
Brief summary
The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.
Interventions
DRUGSPD476 (1.2g)
1.2g SPD476 once daily (QD) orally
DRUGSPD476 (2.4 g)
2.4g SPD476 QD orally
DRUGSPD476 (4.8 g)
4.8g SPD476 QD orally
DRUGPlacebo
QD orally
Sponsors
Shire
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Males and females =\>18yrs of age. 2. 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. 3. An episode of acute diverticulitis that resolved without colonic resection. 4. Confirmation of diverticulosis via endoscopic evaluation of the sigmoid colon with at least three diverticula noted.
Exclusion criteria
1. Previous colorectal surgery, including surgical intervention for diverticular disease (with the exception of haemorrhoidectomy, colonic removal of polyps, and appendectomy) 2. Active peptic ulcer disease 3. History of or current presence of inflammatory bowel disease (IBD) 4. Subjects with active irritable bowel syndrome (IBS) requiring ongoing medication 5. Allergy or hypersensitivity to aspirin or related compounds 6. Allergy to radiologic contrast agents 7. Use of another Investigational product within 30 days of Baseline 8. Use of antibiotic therapy within 4 weeks of Baseline 9. 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 10. Use of systemic or rectal steroids within 6 weeks of Baseline. Use of inhaled or nasal steroids is acceptable 11. Use of anti-inflammatory drugs, (NSIADs, COX-2 inhibitors) including aspirin (except for cardiac prophylaxis) and ibuprofen, on a regular and ongoing basis 12. History of alcohol or other substance abuse within the previous year 13. Active or recent history of endometriosis or dysmenorrhoea within 6 months prior to Baseline 14. Females who are lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Subjects Without Recurrence of Diverticulitis | Up to 104 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | Up to 104 weeks | 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 | Up to 104 weeks | 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 Who Were CT-Recurrence Free of Diverticulitis | Up to 104 weeks | 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 More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | Up to 104 weeks | 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 | Up to 104 weeks | — |
| Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | Up to 104 weeks | 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. |
Countries
Argentina, Australia, Colombia, France, India, Israel, New Zealand, Spain, Sweden, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SPD476 (1.2 g) 1.2 g administered orally once daily | 145 |
| SPD476 (2.4 g) 2.4 g administered orally once daily | 145 |
| SPD476 (4.8 g) 4.8 g administered orally once daily | 151 |
| Placebo Placebo administered orally once daily | 149 |
| Total | 590 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Accepted only monthly telephone calls | 1 | 0 | 0 | 0 |
| Overall Study | Adverse Event | 10 | 18 | 19 | 9 |
| Overall Study | Diverticulitis attack | 0 | 0 | 1 | 1 |
| Overall Study | Husband against study | 0 | 0 | 1 | 0 |
| Overall Study | Lack of Efficacy | 34 | 35 | 47 | 36 |
| Overall Study | Lack of time | 0 | 1 | 0 | 0 |
| Overall Study | Lost to Follow-up | 7 | 5 | 5 | 6 |
| Overall Study | Missed visit | 1 | 0 | 0 | 0 |
| Overall Study | Moved | 2 | 0 | 1 | 0 |
| Overall Study | Non-adherence to visits | 0 | 1 | 0 | 0 |
| Overall Study | Non-compliance | 0 | 2 | 1 | 0 |
| Overall Study | Patient difficulties | 0 | 1 | 0 | 0 |
| Overall Study | Physician Decision | 0 | 0 | 3 | 0 |
| Overall Study | Protocol Violation | 1 | 3 | 1 | 0 |
| Overall Study | Site closure | 1 | 0 | 0 | 0 |
| Overall Study | Sponsor decision | 0 | 1 | 0 | 0 |
| Overall Study | Suspected Diverticulitis Recurrence | 1 | 1 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 17 | 15 | 16 | 18 |
Baseline characteristics
| Characteristic | SPD476 (2.4 g) | SPD476 (4.8 g) | SPD476 (1.2 g) | Placebo | Total |
|---|---|---|---|---|---|
| Age, Continuous | 54.5 years STANDARD_DEVIATION 11.96 | 54.5 years STANDARD_DEVIATION 11.93 | 55.1 years STANDARD_DEVIATION 11.11 | 57.1 years STANDARD_DEVIATION 10.42 | 55.3 years STANDARD_DEVIATION 11.39 |
| Age, Customized 18 to <35 years | 11 Participants | 8 Participants | 3 Participants | 3 Participants | 25 Participants |
| Age, Customized 35 to <45 years | 17 Participants | 26 Participants | 20 Participants | 14 Participants | 77 Participants |
| Age, Customized 45 to <55 years | 39 Participants | 36 Participants | 49 Participants | 37 Participants | 161 Participants |
| Age, Customized 55 to <65 years | 46 Participants | 51 Participants | 43 Participants | 62 Participants | 202 Participants |
| Age, Customized >= 65 years | 30 Participants | 29 Participants | 28 Participants | 31 Participants | 118 Participants |
| Region of Enrollment Argentina | 3 Participants | 4 Participants | 5 Participants | 3 Participants | 15 Participants |
| Region of Enrollment Australia | 5 Participants | 6 Participants | 3 Participants | 5 Participants | 19 Participants |
| Region of Enrollment Colombia | 18 Participants | 18 Participants | 19 Participants | 19 Participants | 74 Participants |
| Region of Enrollment France | 6 Participants | 6 Participants | 5 Participants | 6 Participants | 23 Participants |
| Region of Enrollment India | 2 Participants | 3 Participants | 4 Participants | 4 Participants | 13 Participants |
| Region of Enrollment Israel | 24 Participants | 23 Participants | 24 Participants | 24 Participants | 95 Participants |
| Region of Enrollment New Zealand | 4 Participants | 4 Participants | 3 Participants | 4 Participants | 15 Participants |
| Region of Enrollment Spain | 1 Participants | 4 Participants | 1 Participants | 2 Participants | 8 Participants |
| Region of Enrollment Sweden | 9 Participants | 11 Participants | 9 Participants | 9 Participants | 38 Participants |
| Region of Enrollment United Kingdom | 3 Participants | 3 Participants | 3 Participants | 4 Participants | 13 Participants |
| Region of Enrollment United States | 70 Participants | 69 Participants | 69 Participants | 69 Participants | 277 Participants |
| Sex/Gender, Customized Female | 69 Participants | 71 Participants | 64 Participants | 71 Participants | 275 Participants |
| Sex/Gender, Customized Male | 74 Participants | 79 Participants | 79 Participants | 76 Participants | 308 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 109 / 143 | 106 / 143 | 101 / 150 | 112 / 147 |
| serious Total, serious adverse events | 16 / 143 | 15 / 143 | 18 / 150 | 16 / 147 |
Outcome results
Primary
Percent of Subjects Without Recurrence of Diverticulitis
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.
Time frame: Up to 104 weeks
Population: Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SPD476 (1.2 g) | Percent of Subjects Without Recurrence of Diverticulitis | 62.2 percentage of subjects |
| SPD476 (2.4 g) | Percent of Subjects Without Recurrence of Diverticulitis | 62.9 percentage of subjects |
| SPD476 (4.8 g) | Percent of Subjects Without Recurrence of Diverticulitis | 52.7 percentage of subjects |
| Placebo | Percent of Subjects Without Recurrence of Diverticulitis | 64.6 percentage of subjects |
p-value: 0.047Cochran-Mantel-Haenszel
p-value: 0.741Cochran-Mantel-Haenszel
p-value: 0.78Cochran-Mantel-Haenszel
Secondary
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative
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.
Time frame: Up to 104 weeks
Population: Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD476 (1.2 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | Negative | 0 Number of CT scans |
| SPD476 (1.2 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | Presence of abdominal pain | 0 Number of CT scans |
| SPD476 (1.2 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | 15% increase in WBC from baseline | 0 Number of CT scans |
| SPD476 (1.2 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | Presence of abdominal pain + 15% increase in WBC | 0 Number of CT scans |
| SPD476 (2.4 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | Presence of abdominal pain | 2 Number of CT scans |
| SPD476 (2.4 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | 15% increase in WBC from baseline | 1 Number of CT scans |
| SPD476 (2.4 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | Presence of abdominal pain + 15% increase in WBC | 0 Number of CT scans |
| SPD476 (2.4 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | Negative | 3 Number of CT scans |
| SPD476 (4.8 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | 15% increase in WBC from baseline | 0 Number of CT scans |
| SPD476 (4.8 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | Presence of abdominal pain | 2 Number of CT scans |
| SPD476 (4.8 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | Presence of abdominal pain + 15% increase in WBC | 0 Number of CT scans |
| SPD476 (4.8 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | Negative | 2 Number of CT scans |
| Placebo | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | Presence of abdominal pain + 15% increase in WBC | 1 Number of CT scans |
| Placebo | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | Presence of abdominal pain | 3 Number of CT scans |
| Placebo | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | Negative | 3 Number of CT scans |
| Placebo | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative | 15% increase in WBC from baseline | 1 Number of CT scans |
Secondary
Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive
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.
Time frame: Up to 104 weeks
Population: Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD476 (1.2 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | Positive | 0 Number of CT scans |
| SPD476 (1.2 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | Presence of abdominal pain | 0 Number of CT scans |
| SPD476 (1.2 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | 15% increase in WBC from baseline | 0 Number of CT scans |
| SPD476 (1.2 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | Presence of abdominal pain + 15% increase in WBC | 0 Number of CT scans |
| SPD476 (2.4 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | Presence of abdominal pain | 0 Number of CT scans |
| SPD476 (2.4 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | 15% increase in WBC from baseline | 0 Number of CT scans |
| SPD476 (2.4 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | Presence of abdominal pain + 15% increase in WBC | 0 Number of CT scans |
| SPD476 (2.4 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | Positive | 0 Number of CT scans |
| SPD476 (4.8 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | 15% increase in WBC from baseline | 0 Number of CT scans |
| SPD476 (4.8 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | Presence of abdominal pain | 1 Number of CT scans |
| SPD476 (4.8 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | Presence of abdominal pain + 15% increase in WBC | 0 Number of CT scans |
| SPD476 (4.8 g) | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | Positive | 1 Number of CT scans |
| Placebo | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | Presence of abdominal pain + 15% increase in WBC | 0 Number of CT scans |
| Placebo | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | Presence of abdominal pain | 1 Number of CT scans |
| Placebo | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | Positive | 1 Number of CT scans |
| Placebo | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive | 15% increase in WBC from baseline | 0 Number of CT scans |
Secondary
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative
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.
Time frame: Up to 104 weeks
Population: Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD476 (1.2 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative | Negative | 19 Number of CT scans |
| SPD476 (1.2 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative | Presence of abdominal pain | 19 Number of CT scans |
| SPD476 (1.2 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative | 15% increase in WBC from baseline | 5 Number of CT scans |
| SPD476 (1.2 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative | Presence in abdominal pain + 15% increase in WBC | 5 Number of CT scans |
| SPD476 (2.4 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative | Presence of abdominal pain | 8 Number of CT scans |
| SPD476 (2.4 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative | 15% increase in WBC from baseline | 2 Number of CT scans |
| SPD476 (2.4 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative | Presence in abdominal pain + 15% increase in WBC | 2 Number of CT scans |
| SPD476 (2.4 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative | Negative | 10 Number of CT scans |
| SPD476 (4.8 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative | 15% increase in WBC from baseline | 2 Number of CT scans |
| SPD476 (4.8 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative | Presence of abdominal pain | 5 Number of CT scans |
| SPD476 (4.8 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative | Presence in abdominal pain + 15% increase in WBC | 2 Number of CT scans |
| SPD476 (4.8 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative | Negative | 5 Number of CT scans |
| Placebo | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative | Presence in abdominal pain + 15% increase in WBC | 1 Number of CT scans |
| Placebo | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative | Presence of abdominal pain | 7 Number of CT scans |
| Placebo | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative | Negative | 10 Number of CT scans |
| Placebo | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative | 15% increase in WBC from baseline | 1 Number of CT scans |
Secondary
Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive
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.
Time frame: Up to 104 weeks
Population: Suspected Recurrence of Diverticulitis consists of subjects in the Full Analysis Set who had a CT scan performed. Since subjects may have had more than one suspected recurrence, counts are of the number of CT scans, not the number of subjects.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| SPD476 (1.2 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | Positive | 37 Number of CT scans |
| SPD476 (1.2 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | Presence of abdominal pain | 30 Number of CT scans |
| SPD476 (1.2 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | 15% increase in WBC from baseline | 17 Number of CT scans |
| SPD476 (1.2 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | Presence in abdominal pain + 15% increase in WBC | 17 Number of CT scans |
| SPD476 (2.4 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | Presence of abdominal pain | 39 Number of CT scans |
| SPD476 (2.4 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | 15% increase in WBC from baseline | 24 Number of CT scans |
| SPD476 (2.4 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | Presence in abdominal pain + 15% increase in WBC | 24 Number of CT scans |
| SPD476 (2.4 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | Positive | 39 Number of CT scans |
| SPD476 (4.8 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | 15% increase in WBC from baseline | 28 Number of CT scans |
| SPD476 (4.8 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | Presence of abdominal pain | 54 Number of CT scans |
| SPD476 (4.8 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | Presence in abdominal pain + 15% increase in WBC | 28 Number of CT scans |
| SPD476 (4.8 g) | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | Positive | 55 Number of CT scans |
| Placebo | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | Presence in abdominal pain + 15% increase in WBC | 23 Number of CT scans |
| Placebo | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | Presence of abdominal pain | 37 Number of CT scans |
| Placebo | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | Positive | 38 Number of CT scans |
| Placebo | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive | 15% increase in WBC from baseline | 24 Number of CT scans |
Secondary
Percent of Subjects Requiring Surgery for Diverticulitis
Time frame: Up to 104 weeks
Population: Full Analysis Set consists of all subjects who were randomized and took at least 1 dose of investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SPD476 (1.2 g) | Percent of Subjects Requiring Surgery for Diverticulitis | 2.8 percentage of subjects |
| SPD476 (2.4 g) | Percent of Subjects Requiring Surgery for Diverticulitis | 2.8 percentage of subjects |
| SPD476 (4.8 g) | Percent of Subjects Requiring Surgery for Diverticulitis | 3.3 percentage of subjects |
| Placebo | Percent of Subjects Requiring Surgery for Diverticulitis | 2.0 percentage of subjects |
Secondary
Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis
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.
Time frame: Up to 104 weeks
Population: Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| SPD476 (1.2 g) | Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis | 61.5 percentage of subjects |
| SPD476 (2.4 g) | Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis | 62.2 percentage of subjects |
| SPD476 (4.8 g) | Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis | 52.7 percentage of subjects |
| Placebo | Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis | 63.9 percentage of subjects |
p-value: 0.063Cochran-Mantel-Haenszel
p-value: 0.736Cochran-Mantel-Haenszel
p-value: 0.78Cochran-Mantel-Haenszel