PREVENT1: Prevention of Recurrence of Diverticulitis
Study Details
Study Description
Brief Summary
The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: SPD476 (1.2 g)
|
Drug: SPD476 (1.2g)
1.2g SPD476 once daily (QD) orally
Other Names:
|
Experimental: SPD476 (2.4 g)
|
Drug: SPD476 (2.4 g)
2.4g SPD476 QD orally
Other Names:
|
Experimental: SPD476 (4.8 g)
|
Drug: SPD476 (4.8 g)
4.8g SPD476 QD orally
Other Names:
|
Placebo Comparator: Placebo
|
Drug: Placebo
QD orally
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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 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.
- 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.
- 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]
Eligibility Criteria
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
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Dedicated Clinical Research | Litchfield Park | Arizona | United States | 85340 |
2 | Lynn Institute of the Ozarks | Little Rock | Arkansas | United States | 72205 |
3 | Advanced Clinical Research Institute | Anaheim | California | United States | 92108 |
4 | GW Research | Chula Vista | California | United States | 91910 |
5 | Monterey Bay GI Research Institute, Inc | Monterey | California | United States | 93940 |
6 | Rancho Cucamonga C. Trials | Rancho Cucamonga | California | United States | 91730 |
7 | Clinical Trials Research | Roseville | California | United States | 95661 |
8 | Medical Associates Research | San Diego | California | United States | 92123 |
9 | Torrance Clinical Research | Torrance | California | United States | 90505 |
10 | Rocky Mountain Gastroenterology Associates | Thornton | Colorado | United States | 80229 |
11 | Gastroenterology Associates of Fairfield County | Bridgeport | Connecticut | United States | 06606 |
12 | Yale Center for Clinical Investigation | New Haven | Connecticut | United States | 06520 |
13 | ZASA Clinical Research | Boynton Beach | Florida | United States | 33472 |
14 | Clinical Research of West Florida, Inc. | Clearwater | Florida | United States | 33765 |
15 | Borland-Groover Clinic | Jacksonville | Florida | United States | 32256 |
16 | Compass Research | Orlando | Florida | United States | 32806 |
17 | Accord Clinic Research, LLC | Port Orange | Florida | United States | 32129 |
18 | Florida Medical Clinic/Tampa Clinical Trials | Tampa | Florida | United States | 33613 |
19 | Gastroenterology Associates of Central Georgia, LLC | Macon | Georgia | United States | 31201 |
20 | Saint John's Research Institute | Anderson | Indiana | United States | 46016 |
21 | Digestive & Liver Disease Consultants | Clive | Iowa | United States | 50325 |
22 | New Orleans Research Institute | Metairie | Louisiana | United States | 70006 |
23 | Digestive Disease Associates | Baltimore | Maryland | United States | 21229 |
24 | Endoscopic Microsurgery Associates, PA | Towson | Maryland | United States | 21204 |
25 | Borgess Research Institute | Kalamazoo | Michigan | United States | 49048 |
26 | Jefferson City Medical Group | Jefferson City | Missouri | United States | 65109 |
27 | South Jersey Gastroenterology, P.A. | Marlton | New Jersey | United States | 08053 |
28 | Howard Guss, DO | Ocean City | New Jersey | United States | 07712 |
29 | New Jersey Physicians, LLC | Passaic | New Jersey | United States | 07055 |
30 | Allied Gastrointestinal Associates, P.A. | Voorhees | New Jersey | United States | 08043 |
31 | Regional Clinical Research | Endwell | New York | United States | 13760 |
32 | Long Island Clinical Research Associates | Great Neck | New York | United States | 11021 |
33 | Long Island Gastrointestinal Research Group | Great Neck | New York | United States | 11023 |
34 | Research Associates of New York | New York | New York | United States | 10075 |
35 | Vital Research | Greensboro | North Carolina | United States | 27408 |
36 | Gastroenterology Specialists, Inc | Canton | Ohio | United States | 44718 |
37 | Memorial Research Center | Chattanooga | Tennessee | United States | 37404 |
38 | Gastroenterology Associates Clinical Research | Kingsport | Tennessee | United States | 37660 |
39 | Nashville Medical Research Institute | Nashville | Tennessee | United States | 37205 |
40 | Harris Methodist Fort Worth Hospital | Fort Worth | Texas | United States | 76104 |
41 | Kelsey-Seybold Clinic | Houston | Texas | United States | 77005 |
42 | Clinical Trials of Texas, Inc. | San Antonio | Texas | United States | 78229 |
43 | Stone Oak Research Foundation | San Antonio | Texas | United States | 78258 |
44 | Blue Ridge Medical Research | Lynchburg | Virginia | United States | 24502 |
45 | Digestive and Liver Disease Specialists | Norfolk | Virginia | United States | 23502 |
46 | Aurora Advanced Healthcare, Inc. - Clinical Research Center | Milwaukee | Wisconsin | United States | 53209 |
47 | CIMEL | Lanus | Buenos Aires | Argentina | B1824KAS |
48 | Instituto Gamma | Rosario | Santa Fe | Argentina | S2000DFD |
49 | Hospital Bocalandro | Buenos Aires | Argentina | B1657BHD | |
50 | Hospital Heroes de Malvinas | Buenos Aires | Argentina | B1722FJN | |
51 | GEDYT | Buenos Aires | Argentina | C1117AAA | |
52 | Sanatorio Guemes | Buenos Aires | Argentina | C1180AAX | |
53 | Cibic S.A. | Santa Fe | Argentina | S2000BCG | |
54 | The Canberra Hospital | Garran | Australian Capital Territory | Australia | 2605 |
55 | Ballarat Base Hospital | Ballarat | Victoria | Australia | 3350 |
56 | St Vincent's Hospital (Melb) LTD | Melbourne | Victoria | Australia | 3065 |
57 | Royal Adelaide Hospital | Adelaide | Australia | 5000 | |
58 | Royal Prince Albert Hospital | Camperdown | Australia | 2050 | |
59 | Frankston Private | Frankston | Australia | 3199 | |
60 | Bayside Gastroenterology | Frankston | Australia | VIC 3199 | |
61 | Fremantle Hospital | Fremantle | Australia | 6160 | |
62 | Ugasend S.A | Barranquilla | Colombia | ||
63 | Clinica Colsinatas SA | Bogota | Colombia | ||
64 | FOQUS, Centro de Investigacion Clinica | Bogota | Colombia | ||
65 | Fundacion Clinica Abood Shaio | Bogota | Colombia | ||
66 | Hospital Universitario San Ignacio | Bogota | Colombia | ||
67 | Clinica Las Americas | Medellin | Colombia | ||
68 | CHU de Strasbourg | Strasbourg | Alsace | France | 67200 |
69 | Hepato Gastro Enterology | Nantes | Brittany | France | 44033 |
70 | Hopital Charles Nicolle | Rouen | Normandy | France | 76031 |
71 | Hopital Beaujon | Clichy | Paris | France | 92118 |
72 | Cabinet de Gastro-enterologie du Dr Alain Thevenin | Saint Quentin | Picardie | France | 02100 |
73 | Hopital I'Archet | Nice | Provence-Alpes-Côte d'Azur | France | 06200 |
74 | Clinique Bouchard | Marseille | Provence-Alpes-Côte-d'Azur | France | 13000 |
75 | CHU de Grenoble | Grenoble | Rhone-Alpes | France | 38043 |
76 | Cabinet du Dr Olivier Delette | Lille | France | 59000 | |
77 | Dr Michel Regensberg | Paris | France | 75017 | |
78 | Baby Memorial Hospital | Calicut | Kerala | India | 673004 |
79 | Lakeshore Hospital & Research Centre Ltd | Cochin | Kerala | India | 682304 |
80 | Sree Gokulam Medical College and Research Foundation | Trivandrum | Kerala | India | 695607 |
81 | Dayanand Medical College and Hospital | Ludhiana | Punjab | India | 141001 |
82 | S R Kalla Memorial Hospital | Jaipur | Rajasthan | India | |
83 | Aceer | Chennai | Tamil Nadu | India | 600020 |
84 | Institute of Postgraduate Medical Education and Research | Kolkata | West Bengal | India | 700020 |
85 | Brahmin Mitra Mandal Society | Ahmedabad | India | 380006 | |
86 | Ruby Hall Clinic | Pune | India | 411 001 | |
87 | Krishna Institute of Medical Sciences | Secunderabad | India | 500 003 | |
88 | Emek Medical Center | Afula | Israel | 18101 | |
89 | Barzilai Medical Centre | Ashkelon | Israel | 78278 | |
90 | Soroka Medical Center | Beer Sheva | Israel | 84101 | |
91 | Bnai Zion Medical Center | Haifa | Israel | 31048 | |
92 | Rambam Medical Center | Haifa | Israel | 63106 | |
93 | Hadassah Ein-Karem Medical Center | Jerusalem | Israel | ||
94 | Meir Medical Centre | Kfar-Saba | Israel | ||
95 | Rabin Medical Center | Petah-Tikva | Israel | 49100 | |
96 | Kaplan Medical Center | Rechovot | Israel | ||
97 | The Tel Aviv Sourasky Medical Center | Tel Aviv | Israel | 64239 | |
98 | The Chaim Sheba Medical Center | Tel Hashomer | Israel | 52621 | |
99 | Assaf Harofeh Medical Center | Zerifin | Israel | 70300 | |
100 | Shakespeare Specialist Group | Takapuna | Auckland | New Zealand | |
101 | Auckland City Hospital | Auckland | New Zealand | ||
102 | CURT Medical Trials Trust Board | Christchurch | New Zealand | ||
103 | Dunedin Hospital | Dunedin | New Zealand | ||
104 | Waikato Hospital | Hamilton | New Zealand | 3240 | |
105 | Tauranga Hospital | Tauranga | New Zealand | ||
106 | Hospital Valle de Hebron | Barcelona | Spain | 08035 | |
107 | Hospital Universitario de Bellvitge | Barcelona | Spain | 08907 | |
108 | Hospital Son Dureta | Palma de Mallorca | Spain | 07014 | |
109 | Hospital de Donostia | San Sebastian | Spain | 20014 | |
110 | Hospital General Universitario de Valencia | Valencia | Spain | 46014 | |
111 | University Hospital/Eastern Hospital | Goteborg | Sweden | 41685 | |
112 | University Hospital Linköping | Linköping | Sweden | 58185 | |
113 | VO Internmedicin | Stockholm | Sweden | 11883 | |
114 | Karolinska University Hospital | Stockholm | Sweden | 17176 | |
115 | Danderyd Hospital | Stockholm | Sweden | 18288 | |
116 | Kirurgkliniken | Uppsala | Sweden | ||
117 | Norfolk/Norwich University Hospital | Norwich | East Anglia | United Kingdom | NR4 7UY |
118 | St Mark's Hospital | Harrow | London | United Kingdom | HA1 3UJ |
119 | King's College Hospital | London | United Kingdom | SE5 9RS | |
120 | Chelsea & Westminster Hospital | London | United Kingdom | SW10 9NH | |
121 | Imperial College London | London | United Kingdom | W12 0NN |
Sponsors and Collaborators
- Shire
Investigators
- Study Director: Study Director, Takeda
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SPD476-313
- 2007-004895-37
Study Results
Participant Flow
Recruitment Details | |
---|---|
Pre-assignment Detail |
Arm/Group Title | SPD476 (1.2 g) | SPD476 (2.4 g) | SPD476 (4.8 g) | Placebo |
---|---|---|---|---|
Arm/Group Description | 1.2 g administered orally once daily | 2.4 g administered orally once daily | 4.8 g administered orally once daily | Placebo administered orally once daily |
Period Title: Overall Study | ||||
STARTED | 145 | 145 | 151 | 149 |
COMPLETED | 70 | 62 | 55 | 78 |
NOT COMPLETED | 75 | 83 | 96 | 71 |
Baseline Characteristics
Arm/Group Title | SPD476 (1.2 g) | SPD476 (2.4 g) | SPD476 (4.8 g) | Placebo | Total |
---|---|---|---|---|---|
Arm/Group Description | 1.2 g administered orally once daily | 2.4 g administered orally once daily | 4.8 g administered orally once daily | Placebo administered orally once daily | Total of all reporting groups |
Overall Participants | 145 | 145 | 151 | 149 | 590 |
Age (years) [Mean (Standard Deviation) ] | |||||
Mean (Standard Deviation) [years] |
55.1
(11.11)
|
54.5
(11.96)
|
54.5
(11.93)
|
57.1
(10.42)
|
55.3
(11.39)
|
Age, Customized (Count of Participants) | |||||
18 to <35 years |
3
2.1%
|
11
7.6%
|
8
5.3%
|
3
2%
|
25
4.2%
|
35 to <45 years |
20
13.8%
|
17
11.7%
|
26
17.2%
|
14
9.4%
|
77
13.1%
|
45 to <55 years |
49
33.8%
|
39
26.9%
|
36
23.8%
|
37
24.8%
|
161
27.3%
|
55 to <65 years |
43
29.7%
|
46
31.7%
|
51
33.8%
|
62
41.6%
|
202
34.2%
|
>= 65 years |
28
19.3%
|
30
20.7%
|
29
19.2%
|
31
20.8%
|
118
20%
|
Sex/Gender, Customized (Count of Participants) | |||||
Female |
64
44.1%
|
69
47.6%
|
71
47%
|
71
47.7%
|
275
46.6%
|
Male |
79
54.5%
|
74
51%
|
79
52.3%
|
76
51%
|
308
52.2%
|
Region of Enrollment (Count of Participants) | |||||
Argentina |
5
3.4%
|
3
2.1%
|
4
2.6%
|
3
2%
|
15
2.5%
|
Australia |
3
2.1%
|
5
3.4%
|
6
4%
|
5
3.4%
|
19
3.2%
|
Colombia |
19
13.1%
|
18
12.4%
|
18
11.9%
|
19
12.8%
|
74
12.5%
|
France |
5
3.4%
|
6
4.1%
|
6
4%
|
6
4%
|
23
3.9%
|
India |
4
2.8%
|
2
1.4%
|
3
2%
|
4
2.7%
|
13
2.2%
|
Israel |
24
16.6%
|
24
16.6%
|
23
15.2%
|
24
16.1%
|
95
16.1%
|
New Zealand |
3
2.1%
|
4
2.8%
|
4
2.6%
|
4
2.7%
|
15
2.5%
|
Spain |
1
0.7%
|
1
0.7%
|
4
2.6%
|
2
1.3%
|
8
1.4%
|
Sweden |
9
6.2%
|
9
6.2%
|
11
7.3%
|
9
6%
|
38
6.4%
|
United Kingdom |
3
2.1%
|
3
2.1%
|
3
2%
|
4
2.7%
|
13
2.2%
|
United States |
69
47.6%
|
70
48.3%
|
69
45.7%
|
69
46.3%
|
277
46.9%
|
Outcome Measures
Title | Percent of Subjects Who Were CT-Recurrence Free of Diverticulitis |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product. |
Arm/Group Title | SPD476 (1.2 g) | SPD476 (2.4 g) | SPD476 (4.8 g) | Placebo |
---|---|---|---|---|
Arm/Group Description | 1.2 g administered orally once daily | 2.4 g administered orally once daily | 4.8 g administered orally once daily | Placebo administered orally once daily |
Measure Participants | 143 | 143 | 150 | 147 |
Number [percentage of subjects] |
61.5
|
62.2
|
52.7
|
63.9
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | SPD476 (4.8 g), Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.063 |
Comments | ||
Method | Cochran-Mantel-Haenszel | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | SPD476 (2.4 g), Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.736 |
Comments | ||
Method | Cochran-Mantel-Haenszel | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | SPD476 (1.2 g), Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.780 |
Comments | ||
Method | Cochran-Mantel-Haenszel | |
Comments |
Title | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Positive |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | SPD476 (1.2 g) | SPD476 (2.4 g) | SPD476 (4.8 g) | Placebo |
---|---|---|---|---|
Arm/Group Description | 1.2 g administered orally once daily | 2.4 g administered orally once daily | 4.8 g administered orally once daily | Placebo administered orally once daily |
Measure Participants | 52 | 49 | 55 | 46 |
Positive |
37
|
39
|
55
|
38
|
Presence of abdominal pain |
30
|
39
|
54
|
37
|
15% increase in WBC from baseline |
17
|
24
|
28
|
24
|
Presence in abdominal pain + 15% increase in WBC |
17
|
24
|
28
|
23
|
Title | Percent of Subjects Without Recurrence of Diverticulitis |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product. |
Arm/Group Title | SPD476 (1.2 g) | SPD476 (2.4 g) | SPD476 (4.8 g) | Placebo |
---|---|---|---|---|
Arm/Group Description | 1.2 g administered orally once daily | 2.4 g administered orally once daily | 4.8 g administered orally once daily | Placebo administered orally once daily |
Measure Participants | 143 | 143 | 150 | 147 |
Number [percentage of subjects] |
62.2
|
62.9
|
52.7
|
64.6
|
Statistical Analysis 1
Statistical Analysis Overview | Comparison Group Selection | SPD476 (4.8 g), Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.047 |
Comments | ||
Method | Cochran-Mantel-Haenszel | |
Comments |
Statistical Analysis 2
Statistical Analysis Overview | Comparison Group Selection | SPD476 (2.4 g), Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.741 |
Comments | ||
Method | Cochran-Mantel-Haenszel | |
Comments |
Statistical Analysis 3
Statistical Analysis Overview | Comparison Group Selection | SPD476 (1.2 g), Placebo |
---|---|---|
Comments | ||
Type of Statistical Test | Superiority or Other (legacy) | |
Comments | ||
Statistical Test of Hypothesis | p-Value | 0.780 |
Comments | ||
Method | Cochran-Mantel-Haenszel | |
Comments |
Title | Number of CT Scans Performed Within 7 Days of Suspected Recurrence of Diverticulitis That Were Negative |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | SPD476 (1.2 g) | SPD476 (2.4 g) | SPD476 (4.8 g) | Placebo |
---|---|---|---|---|
Arm/Group Description | 1.2 g administered orally once daily | 2.4 g administered orally once daily | 4.8 g administered orally once daily | Placebo administered orally once daily |
Measure Participants | 52 | 49 | 55 | 46 |
Negative |
19
|
10
|
5
|
10
|
Presence of abdominal pain |
19
|
8
|
5
|
7
|
15% increase in WBC from baseline |
5
|
2
|
2
|
1
|
Presence in abdominal pain + 15% increase in WBC |
5
|
2
|
2
|
1
|
Title | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Positive |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | SPD476 (1.2 g) | SPD476 (2.4 g) | SPD476 (4.8 g) | Placebo |
---|---|---|---|---|
Arm/Group Description | 1.2 g administered orally once daily | 2.4 g administered orally once daily | 4.8 g administered orally once daily | Placebo administered orally once daily |
Measure Participants | 52 | 49 | 55 | 46 |
Positive |
0
|
0
|
1
|
1
|
Presence of abdominal pain |
0
|
0
|
1
|
1
|
15% increase in WBC from baseline |
0
|
0
|
0
|
0
|
Presence of abdominal pain + 15% increase in WBC |
0
|
0
|
0
|
0
|
Title | Number of CT Scans Performed More Than 7 Days From Suspected Recurrence of Diverticulitis That Were Negative |
---|---|
Description | 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 |
Outcome Measure Data
Analysis Population Description |
---|
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/Group Title | SPD476 (1.2 g) | SPD476 (2.4 g) | SPD476 (4.8 g) | Placebo |
---|---|---|---|---|
Arm/Group Description | 1.2 g administered orally once daily | 2.4 g administered orally once daily | 4.8 g administered orally once daily | Placebo administered orally once daily |
Measure Participants | 52 | 49 | 55 | 46 |
Negative |
0
|
3
|
2
|
3
|
Presence of abdominal pain |
0
|
2
|
2
|
3
|
15% increase in WBC from baseline |
0
|
1
|
0
|
1
|
Presence of abdominal pain + 15% increase in WBC |
0
|
0
|
0
|
1
|
Title | Percent of Subjects Requiring Surgery for Diverticulitis |
---|---|
Description | |
Time Frame | Up to 104 weeks |
Outcome Measure Data
Analysis Population Description |
---|
Full Analysis Set consists of all subjects who were randomized and took at least 1 dose of investigational product. |
Arm/Group Title | SPD476 (1.2 g) | SPD476 (2.4 g) | SPD476 (4.8 g) | Placebo |
---|---|---|---|---|
Arm/Group Description | 1.2 g administered orally once daily | 2.4 g administered orally once daily | 4.8 g administered orally once daily | Placebo administered orally once daily |
Measure Participants | 143 | 143 | 150 | 147 |
Number [percentage of subjects] |
2.8
|
2.8
|
3.3
|
2.0
|
Adverse Events
Time Frame | ||||||||
---|---|---|---|---|---|---|---|---|
Adverse Event Reporting Description | ||||||||
Arm/Group Title | SPD476 (1.2 g) | SPD476 (2.4 g) | SPD476 (4.8 g) | Placebo | ||||
Arm/Group Description | 1.2 g administered orally once daily | 2.4 g administered orally once daily | 4.8 g administered orally once daily | Placebo administered orally once daily | ||||
All Cause Mortality |
||||||||
SPD476 (1.2 g) | SPD476 (2.4 g) | SPD476 (4.8 g) | Placebo | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||
Serious Adverse Events |
||||||||
SPD476 (1.2 g) | SPD476 (2.4 g) | SPD476 (4.8 g) | Placebo | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 16/143 (11.2%) | 15/143 (10.5%) | 18/150 (12%) | 16/147 (10.9%) | ||||
Blood and lymphatic system disorders | ||||||||
Iron deficiency anemia | 0/143 (0%) | 1/143 (0.7%) | 0/150 (0%) | 0/147 (0%) | ||||
Cardiac disorders | ||||||||
Angina pectoris | 2/143 (1.4%) | 1/143 (0.7%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Coronary artery disease | 0/143 (0%) | 1/143 (0.7%) | 0/150 (0%) | 0/147 (0%) | ||||
Myocardial ischemia | 0/143 (0%) | 1/143 (0.7%) | 0/150 (0%) | 0/147 (0%) | ||||
Acute myocarcial infarction | 1/143 (0.7%) | 0/143 (0%) | 0/150 (0%) | 2/147 (1.4%) | ||||
Coronary artery insufficiency | 1/143 (0.7%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Ear and labyrinth disorders | ||||||||
Vertigo positional | 0/143 (0%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Endocrine disorders | ||||||||
Autoimmune thyroiditis | 0/143 (0%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Eye disorders | ||||||||
Retinal detachment | 0/143 (0%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Gastrointestinal disorders | ||||||||
Dyspepsia | 0/143 (0%) | 0/143 (0%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Gastritis | 0/143 (0%) | 0/143 (0%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Pancreatitis | 0/143 (0%) | 0/143 (0%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Pancreatitis acute | 0/143 (0%) | 0/143 (0%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Enterovesical fistula | 0/143 (0%) | 1/143 (0.7%) | 0/150 (0%) | 0/147 (0%) | ||||
Gastrointestinal hemorrhage | 0/143 (0%) | 1/143 (0.7%) | 0/150 (0%) | 0/147 (0%) | ||||
Abdominal pain | 1/143 (0.7%) | 0/143 (0%) | 0/150 (0%) | 2/147 (1.4%) | ||||
Large intestine perforation | 1/143 (0.7%) | 0/143 (0%) | 0/150 (0%) | 0/147 (0%) | ||||
Peritoneal hematoma | 1/143 (0.7%) | 0/143 (0%) | 0/150 (0%) | 0/147 (0%) | ||||
General disorders | ||||||||
Pyrexia | 0/143 (0%) | 0/143 (0%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Chills | 0/143 (0%) | 1/143 (0.7%) | 0/150 (0%) | 0/147 (0%) | ||||
Non-cardiac chest pain | 1/143 (0.7%) | 0/143 (0%) | 0/150 (0%) | 0/147 (0%) | ||||
Infections and infestations | ||||||||
Urinary tract infection | 0/143 (0%) | 0/143 (0%) | 2/150 (1.3%) | 0/147 (0%) | ||||
Gastroenteritis | 0/143 (0%) | 1/143 (0.7%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Sepsis | 1/143 (0.7%) | 0/143 (0%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Clostridial infection | 0/143 (0%) | 0/143 (0%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Kidney infection | 0/143 (0%) | 0/143 (0%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Pneumonia primary atypical | 0/143 (0%) | 0/143 (0%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Viral infection | 0/143 (0%) | 0/143 (0%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Cellulitis | 0/143 (0%) | 1/143 (0.7%) | 0/150 (0%) | 0/147 (0%) | ||||
Pneumonia | 1/143 (0.7%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Endophthalmitis | 0/143 (0%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Gastrointestinal infection | 0/143 (0%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Injury, poisoning and procedural complications | ||||||||
Road traffic accident | 2/143 (1.4%) | 0/143 (0%) | 0/150 (0%) | 0/147 (0%) | ||||
Near drowning | 0/143 (0%) | 0/143 (0%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Concussion | 1/143 (0.7%) | 0/143 (0%) | 0/150 (0%) | 0/147 (0%) | ||||
Femoral neck fracture | 1/143 (0.7%) | 0/143 (0%) | 0/150 (0%) | 0/147 (0%) | ||||
Skin injury | 1/143 (0.7%) | 0/143 (0%) | 0/150 (0%) | 0/147 (0%) | ||||
Humerus fracture | 0/143 (0%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Joint dislocation | 0/143 (0%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Metabolism and nutrition disorders | ||||||||
Hypercalcemia | 1/143 (0.7%) | 0/143 (0%) | 0/150 (0%) | 0/147 (0%) | ||||
Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
Uterine cancer | 2/143 (1.4%) | 0/143 (0%) | 0/150 (0%) | 0/147 (0%) | ||||
Prostate cancer | 0/143 (0%) | 0/143 (0%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Breast cancer | 0/143 (0%) | 1/143 (0.7%) | 0/150 (0%) | 0/147 (0%) | ||||
Thyroid neoplasm | 1/143 (0.7%) | 0/143 (0%) | 0/150 (0%) | 0/147 (0%) | ||||
Breast cancer in situ | 0/143 (0%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Laryngeal cancer | 0/143 (0%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Thyroid cancer | 0/143 (0%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Nervous system disorders | ||||||||
Ischemic stroke | 0/143 (0%) | 1/143 (0.7%) | 0/150 (0%) | 0/147 (0%) | ||||
Movement disorder | 0/143 (0%) | 1/143 (0.7%) | 0/150 (0%) | 0/147 (0%) | ||||
Syncope | 0/143 (0%) | 1/143 (0.7%) | 0/150 (0%) | 0/147 (0%) | ||||
Cerebral ischemia | 0/143 (0%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Psychiatric disorders | ||||||||
Alcoholism | 0/143 (0%) | 0/143 (0%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Bipolar II disorder | 0/143 (0%) | 0/143 (0%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Confusional state | 0/143 (0%) | 1/143 (0.7%) | 0/150 (0%) | 0/147 (0%) | ||||
Bipolar disorder | 0/143 (0%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Renal and urinary disorders | ||||||||
Nephrolithiasis | 0/143 (0%) | 0/143 (0%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Pelvi-ureteric obstruction | 0/143 (0%) | 0/143 (0%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Bladder prolapse | 0/143 (0%) | 1/143 (0.7%) | 0/150 (0%) | 0/147 (0%) | ||||
Renal colic | 1/143 (0.7%) | 0/143 (0%) | 0/150 (0%) | 0/147 (0%) | ||||
Renal failure acute | 1/143 (0.7%) | 0/143 (0%) | 0/150 (0%) | 0/147 (0%) | ||||
Stress urinary incontinence | 0/143 (0%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Reproductive system and breast disorders | ||||||||
Benign prostatic hyperplasia | 0/143 (0%) | 1/143 (0.7%) | 0/150 (0%) | 0/147 (0%) | ||||
Ovarian cyst | 0/143 (0%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Respiratory, thoracic and mediastinal disorders | ||||||||
Chronic obstructive pulmonary disease | 1/143 (0.7%) | 0/143 (0%) | 1/150 (0.7%) | 0/147 (0%) | ||||
Nasal septum deviation | 0/143 (0%) | 1/143 (0.7%) | 0/150 (0%) | 0/147 (0%) | ||||
Sinus polyp | 0/143 (0%) | 1/143 (0.7%) | 0/150 (0%) | 0/147 (0%) | ||||
Pulmonary hypertension | 1/143 (0.7%) | 0/143 (0%) | 0/150 (0%) | 0/147 (0%) | ||||
Asthma | 0/143 (0%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Vascular disorders | ||||||||
Aortic Aneurysm | 0/143 (0%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Hypertension | 0/143 (0%) | 0/143 (0%) | 0/150 (0%) | 1/147 (0.7%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
SPD476 (1.2 g) | SPD476 (2.4 g) | SPD476 (4.8 g) | Placebo | |||||
Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
Total | 109/143 (76.2%) | 106/143 (74.1%) | 101/150 (67.3%) | 112/147 (76.2%) | ||||
Gastrointestinal disorders | ||||||||
Abdominal pain | 17/143 (11.9%) | 16/143 (11.2%) | 18/150 (12%) | 16/147 (10.9%) | ||||
Diarrhea | 13/143 (9.1%) | 12/143 (8.4%) | 12/150 (8%) | 12/147 (8.2%) | ||||
Flatulence | 9/143 (6.3%) | 5/143 (3.5%) | 3/150 (2%) | 4/147 (2.7%) | ||||
Constpation | 7/143 (4.9%) | 3/143 (2.1%) | 5/150 (3.3%) | 8/147 (5.4%) | ||||
General disorders | ||||||||
Nausea | 10/143 (7%) | 1/143 (0.7%) | 6/150 (4%) | 5/147 (3.4%) | ||||
Infections and infestations | ||||||||
Urinary tract infection | 14/143 (9.8%) | 12/143 (8.4%) | 8/150 (5.3%) | 17/147 (11.6%) | ||||
Nasopharyngitis | 6/143 (4.2%) | 15/143 (10.5%) | 7/150 (4.7%) | 13/147 (8.8%) | ||||
Upper respiratory tract infection | 9/143 (6.3%) | 3/143 (2.1%) | 10/150 (6.7%) | 14/147 (9.5%) | ||||
Sinusitis | 9/143 (6.3%) | 7/143 (4.9%) | 5/150 (3.3%) | 8/147 (5.4%) | ||||
Influenza | 5/143 (3.5%) | 11/143 (7.7%) | 4/150 (2.7%) | 3/147 (2%) | ||||
Bronchitis | 7/143 (4.9%) | 8/143 (5.6%) | 3/150 (2%) | 3/147 (2%) | ||||
Musculoskeletal and connective tissue disorders | ||||||||
Back pain | 8/143 (5.6%) | 5/143 (3.5%) | 8/150 (5.3%) | 12/147 (8.2%) | ||||
Arthralgia | 7/143 (4.9%) | 5/143 (3.5%) | 4/150 (2.7%) | 13/147 (8.8%) | ||||
Nervous system disorders | ||||||||
Headache | 13/143 (9.1%) | 6/143 (4.2%) | 14/150 (9.3%) | 10/147 (6.8%) | ||||
Vascular disorders | ||||||||
Hypertension | 5/143 (3.5%) | 8/143 (5.6%) | 6/150 (4%) | 1/147 (0.7%) |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
If a multicenter publication is not submitted within twelve (12) months after conclusion, abandonment or termination of the Study at all sites, or after Sponsor confirms there shall be no multicenter Study publication, the Institution and/or such Principal Investigator may publish the results from the Institution site individually.
Results Point of Contact
Name/Title | Study Director |
---|---|
Organization | Shire |
Phone | +1 866 842 5335 |
ClinicalTransparency@shire.com |
- SPD476-313
- 2007-004895-37