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PREVENT2: Prevention of Recurrence of Diverticulitis

Sponsor
Shire (Industry)
Overall Status
Completed
CT.gov ID
NCT00545103
Collaborator
(none)
592
Enrollment
131
Locations
4
Arms
47.7
Actual Duration (Months)
4.5
Patients Per Site
0.1
Patients Per Site Per Month

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
  • Drug: SPD476, MMX™ mesalazine, 1.2g extended release tablet
  • Drug: SPD476, MMX™ mesalazine, 2.4g extended release tablet
  • Drug: SPD476, MMX™ mesalazine, 4.8g extended release tablet
  • Drug: Placebo
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
592 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, 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.
Actual Study Start Date :
Dec 6, 2007
Actual Primary Completion Date :
Nov 28, 2011
Actual Study Completion Date :
Nov 28, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: SPD476 (1.2 g)

Drug: SPD476, MMX™ mesalazine, 1.2g extended release tablet
SPD476 1.2g administered Once Daily (QD)
Other Names:
  • LIALDA

    		•
    Experimental: SPD476 (2.4 g)

    Drug: SPD476, MMX™ mesalazine, 2.4g extended release tablet
    SPD476 2.4g administered Once Daily (QD)
    Other Names:
  • LIALDA

    		•
    Experimental: SPD476 (4.8 g)

    Drug: SPD476, MMX™ mesalazine, 4.8g extended release tablet
    SPD476 4.8g administered Once Daily (QD)
    Other Names:
  • LIALDA

    		•
    Placebo Comparator: Placebo

    Drug: Placebo
    Placebo administered Once Daily (QD)

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Percent of Subjects Who Are 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.

    2. 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.

    3. 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.

    4. 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.

    5. 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.

    6. Percent of Subjects Requiring Surgery for Diverticulitis [up to 104 Weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Birmingham Gastroenterology Associates, PC Birmingham Alabama United States 35209
    2 Alabama Clinical Therapeutics, LLC Birmingham Alabama United States 35235
    3 Medical Affiliated Research Center, Inc Huntsville Alabama United States 35801
    4 Alabama Digestive Disorders Center, PC Huntsville Alabama United States 35802
    5 Genova Clinical Research Tucson Arizona United States 85741
    6 Digestive and Liver Disease Specialists Garden Grove California United States 92840
    7 High Desert Gastroenterology, Inc. Lancaster California United States 93534
    8 VA Long Beach Healthcare System Long Beach California United States 90822
    9 CA Physicians Research Alliance Oceanside California United States 92083
    10 Digestive Care Medical Center San Carlos California United States 94070
    11 Rider Research Group San Francisco California United States 94117
    12 Huntington Medical Foundation San Marino California United States 91108
    13 Clinical Research of the Rockies Lafayette Colorado United States 80026
    14 Arapahoe Gastroenterology, PC Littleton Colorado United States 80120
    15 Litchfield County Gastroenterology Associates, LLC Torrington Connecticut United States 06790
    16 Madeleine DuPree, MD Boynton Beach Florida United States 33426
    17 Palmetto Research LLC Hialeah Florida United States 33016
    18 Mark Lamet, MD Hollywood Florida United States 33021
    19 Digestive Disease Consultants Maitland Florida United States 32751
    20 University of Miami Miller School of Medicine Miami Florida United States 33136
    21 University of Miami Miami Florida United States 33136
    22 Miami Research Associates Miami Florida United States 33143
    23 United Medical Research New Smyrna Beach Florida United States 32168
    24 West Wind'r Research & Development Tampa Florida United States 33607
    25 Atlanta Gastroenterology Associates Marietta Georgia United States 30067
    26 Gastrointestinal Clinical of Quad Cities Davenport Iowa United States 52807
    27 Sunflower Medical Group Mission Kansas United States 66202
    28 Kansas Medical Clinic Topeka Kansas United States 66606
    29 Gastroenterology Associates, LLC Baton Rouge Louisiana United States 70809
    30 Louisiana Research Center, LLC Shreveport Louisiana United States 71103
    31 Maryland Clinical Trials Annapolis Maryland United States 21401
    32 Chevy Chase Clinical Research Chevy Chase Maryland United States 20815
    33 Mid Atlantic Medical Research Centers Hollywood Maryland United States 20636
    34 Charm City Research, LLC Lutherville Maryland United States 21093
    35 Shah Associates, LLC Prince Frederick Maryland United States 20678
    36 Clinical Research Institute of Michigan, LLC Chesterfield Michigan United States 48047
    37 Center for Digestive Health Troy Michigan United States 48098
    38 Gastrointestinal Associates, PA Jackson Mississippi United States 39202
    39 Center for Digestive & Liver Diseases, Inc Mexico Missouri United States 65265
    40 Sundance Clinical Research Saint Louis Missouri United States 63141
    41 The Gastroenterology Group of South Jersey Vineland New Jersey United States 08360
    42 NY Center for Clinical Research Lake Success New York United States 11042
    43 Concorde Medical Group New York New York United States 10016
    44 Cumberland Research Associates Fayetteville North Carolina United States 28304
    45 LeBauer Research Associates, PA Greensboro North Carolina United States 27403
    46 Wake Research Associates Raleigh North Carolina United States 27612
    47 Digestive Health Specialists Winston-Salem North Carolina United States 27103
    48 Consultants for Clinical Research Cincinnati Ohio United States 45219
    49 Digestive Specialists Inc. Dayton Ohio United States 45415
    50 AMH Feasterville Family Health Care Center Feasterville Pennsylvania United States 19053
    51 Digestive Disorders Center Pittsburgh Pennsylvania United States 15213
    52 Clinsearch, LLC Chattanooga Tennessee United States 37404
    53 Memphis Gastroenterology Group, PC Germantown Tennessee United States 38138
    54 Houston Endoscopy and Research Center Houston Texas United States 77024
    55 Hidalgo Clinical Research San Antonio Texas United States 78215
    56 Physician Research Options Murray Utah United States 84070
    57 Granite Peaks Gastroenterology Sandy Utah United States 84094
    58 Northwest Gastroenerology Associates Bellevue Washington United States 98004
    59 Seattle Gastroenterology Associates Seattle Washington United States 98133
    60 Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda. Goiania GO Brazil 74535-170
    61 Universidade Federal de Juiz de Fora Juiz de Fora MG Brazil 36036-330
    62 Hospital Universitário Clementino Fraga Filho Rio de Janeiro RJ Brazil 21.941-913
    63 Hospital de Clinicas de Porto Alegre Porto Alegre RS Brazil 90035-003
    64 Hospital Sao Lucas PUCRS Porto Alegre RS Brazil Porto Alegre
    65 Fundacao Universidade Federal do Rio Grande - Hopsital Universitario Rio Grande RS Brazil 96200-310
    66 Irmandade da Santa Casa de Misericordia de Santos Santos Sao Paolo Brazil 11075-900
    67 Unidade Integrada de Gastroenterologia UNIGASTRO Campinas SP Brazil 13070-040
    68 Hospital Universitario Pedro Ernesto Rio de Janeiro Brazil 20551-030
    69 Centro de Pesquisas Clinicas- CPCLIN Sao Paulo Brazil 01244-030
    70 Liver and Intestinal Research Centre Vancouver British Columbia Canada V5Z 1H2
    71 Topsail Road Medical Clinic St John's Newfoundland and Labrador Canada A1E 2E2
    72 Corunna Medical Research Centre Corunna Ontario Canada N0N 1G0
    73 Cleveland Clinic Canada Toronto Ontario Canada M5J 2T3
    74 Hotel-Dieu de Levis Levis Quebec Canada G6V 3Z1
    75 Omnispec Clinical Research Mirabel Quebec Canada J7J 2K8
    76 Hopital Maisonneuve-Rosemont Montreal Quebec Canada H1T 2M4
    77 Gastroenterology Centre Pointe-Claire Quebec Canada H9R 3J1
    78 Q&T Research Sherbrooke Quebec Canada J1H4J6
    79 Suomen Terveystalo Oyj Jyvaskyla Finland 40100
    80 Kuopio University Hospital Kuopio Finland 70211
    81 Päijat-Häme Central Hospital Lahti Finland 15850
    82 Oulu University Hospital Oulu Finland 90220
    83 Vaasa Central Hospital Vaasa Finland 65130
    84 Synexus ClinPharm GmbH Berlin Berlin Berlin (Hellersdorf) Germany 12627
    85 Gastrologische Gemeinschaftspraxis Herne im Ärztehaus am Evangelischen Krankenhaus Herne Herne Nord-Rhein-Wesfalen Germany 44623
    86 Synexus ClinPharm International GmbH Bochum Germany 44787
    87 Synexus ClinPharm International GmbH Frankfurt Germany 60596
    88 Synexus ClinPharm International GmbH Görlitz Germany 02826
    89 Universitätsklinikum Schleswig-Holstein Kiel Germany 24105
    90 Synexus ClinPharm International GmbH Leipzig Germany 04103
    91 Synexus ClinPharm International GmbH Magdeburg Germany 39104
    92 Synexus ClinPharm International GmbH Potsdam Germany 14467
    93 Peterfy Hospital, Dept. Of Gastroenterology Budapest Hungary H-1076
    94 University of Debrecen, 3rd Dept. Of Medicine Debrecen Hungary H-4032
    95 Bekes Megyei Kepviselotestulet Pandy Kalman Korhaza, Endoszkopos laboratorium Gyula Hungary H-5700
    96 Kaposi Mór Teaching Hospital Kaposvár Hungary H-7400
    97 Karolina Hospital, Dept. of Internal Medicine and Gastroenterology Mosonmagyaróvár Hungary 9200
    98 Jávorszky Ödön Városi Kórhaz, II. Belgyógyászat Vác Hungary 2600
    99 Ospedale Valduce Como Italy 22100
    100 Ospedale Fatebenefratelli ed Oftalmico Milano Italy 20121
    101 Universita degli Studi di Padova Padova Italy 35128
    102 U.O. di Gastroenterologia ed Endoscopia digestiva Torre delle Medicine Azienda Ospedaliera di Parma Parma Italy
    103 Universita di Pavia Cattedra di Gastroenterologia Dipartimento di Medicina Pavia Italy 27100
    104 Azienda Ospedaliera Universitaria Policlinico Tor Vergata Roma Italy 00133
    105 San Camillo Forlanini Roma Italy 00151
    106 Policlinico Univeritario A Gemelli Roma Italy 00168
    107 Policlinico Univeritario A. Gemelli Roma Italy 00168
    108 Meander Medisch Centrum Amersfoort Netherlands 3816
    109 VU Medisch Centrum Amsterdam Netherlands 1081 HV
    110 Academisch Ziekenhuis Maastricht Maastricht Netherlands 6202
    111 Ikazia Ziekenhuis Rotterdam Netherlands 3083
    112 St. Jans Gashuis Weert Netherlands 6001 BE
    113 CMI de Gastroenterologie Dobru Daniela Targu Mures Mures Romania 540461
    114 Spitalul Clinic "Dr. I. Cantacuzino" Bucharest Romania 020475
    115 Institutul Clinic Fundeni Bucharest Romania 022328
    116 Spitalul Universitar de Urgenta Bucuresti Bucharest Romania 050098
    117 Centrul Medical Galenus Targu Mures Romania 540098
    118 Cabinet Particular Policlinic Algomed SRL Timisoara Romania 300002
    119 Policlinica "Dr. Citu" SRL Timisoara Romania 300593
    120 Panorama Medi-Clinic Cape Town Western Cape South Africa 7500
    121 Universitas Hospital Bloemfontein South Africa 9300
    122 Harold Bloch Cape Town South Africa 7130
    123 Panorama Medi-Clinic Cape Town South Africa 7500
    124 Louis Leipoldt Medical Centre Cape Town South Africa 7530
    125 Kingsbury Hospital Cape Town South Africa 7708
    126 Parklands Medical Centre Durban South Africa 4001
    127 Chelmsford Medical Centre 2 Durban South Africa
    128 Milpark Hospital Johannesburg South Africa 2006
    129 Linksfield Park Clinic Johannesburg South Africa 2192
    130 Johannesburg General Hospital Johannesburg South Africa 2193
    131 Kloof Medi-Clinic Pretoria South Africa 0143

    Sponsors and Collaborators

    • Shire

    Investigators

    • Study Director: Study Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shire
    ClinicalTrials.gov Identifier:
    NCT00545103
    Other Study ID Numbers:
    • SPD476-314
    • 2007-004896-20
    First Posted:
    Oct 17, 2007
    Last Update Posted:
    Jun 11, 2021
    Last Verified:
    May 1, 2021
    Additional relevant MeSH terms:
    Diverticulitis
    Recurrence
    Mesalamine

    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 148 148 150 146
    COMPLETED 73 70 74 76
    NOT COMPLETED 75 78 76 70

    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 148 147 149 142 586
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    57.8
    (10.88)
    54.2
    (10.10)
    56.7
    (11.76)
    55.7
    (11.15)
    56.1
    (11.04)
    Age, Customized (Count of Participants)
    18 to < 35 years
    1
    0.7%
    4
    2.7%
    5
    3.4%
    6
    4.2%
    16
    2.7%
    35 to < 45 years
    16
    10.8%
    21
    14.3%
    18
    12.1%
    16
    11.3%
    71
    12.1%
    45 to < 55 years
    42
    28.4%
    50
    34%
    41
    27.5%
    40
    28.2%
    173
    29.5%
    55 to < 65 years
    45
    30.4%
    48
    32.7%
    45
    30.2%
    45
    31.7%
    183
    31.2%
    >= 65 years
    44
    29.7%
    24
    16.3%
    40
    26.8%
    35
    24.6%
    143
    24.4%
    Sex: Female, Male (Count of Participants)
    Female
    83
    56.1%
    71
    48.3%
    88
    59.1%
    72
    50.7%
    314
    53.6%
    Male
    65
    43.9%
    76
    51.7%
    61
    40.9%
    70
    49.3%
    272
    46.4%
    Region of Enrollment (Count of Participants)
    United States
    89
    60.1%
    88
    59.9%
    88
    59.1%
    86
    60.6%
    351
    59.9%
    Hungary
    2
    1.4%
    3
    2%
    6
    4%
    3
    2.1%
    14
    2.4%
    Canada
    5
    3.4%
    5
    3.4%
    4
    2.7%
    5
    3.5%
    19
    3.2%
    Finland
    4
    2.7%
    5
    3.4%
    5
    3.4%
    4
    2.8%
    18
    3.1%
    Brazil
    10
    6.8%
    9
    6.1%
    10
    6.7%
    11
    7.7%
    40
    6.8%
    Romania
    10
    6.8%
    12
    8.2%
    11
    7.4%
    9
    6.3%
    42
    7.2%
    South Africa
    14
    9.5%
    16
    10.9%
    15
    10.1%
    15
    10.6%
    60
    10.2%
    Netherlands
    5
    3.4%
    3
    2%
    5
    3.4%
    5
    3.5%
    18
    3.1%
    Germany
    7
    4.7%
    6
    4.1%
    4
    2.7%
    4
    2.8%
    21
    3.6%
    Italy
    2
    1.4%
    1
    0.7%
    2
    1.3%
    4
    2.8%
    9
    1.5%

    Outcome Measures

    1. Primary Outcome
    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 148 147 149 142
    Number [percentage of subjects]
    62.8
    59.2
    69.1
    67.6
    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 0.778
    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 0.159
    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 0.368
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    2. Secondary Outcome
    Title Percent of Subjects Who Are 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
    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 148 147 149 142
    Number [percentage of subjects]
    62.8
    59.2
    69.1
    66.9
    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 0.685
    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 0.198
    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 0.441
    Comments
    Method Cochran-Mantel-Haenszel
    Comments
    3. Secondary Outcome
    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 55 52 51 40
    Positive
    49
    45
    35
    30
    Presence of abdominal pain
    48
    39
    34
    29
    15% increase in WBC from baseline
    23
    24
    18
    11
    Abdominal pain + 15% increase in WBC
    23
    22
    18
    11
    4. Secondary Outcome
    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 55 52 51 40
    Negative
    9
    8
    22
    15
    Presence of abdominal pain
    8
    6
    17
    12
    15% increase in WBC from Baseline
    1
    2
    4
    4
    Abdominal pain + 15% increase in WBC
    1
    2
    4
    3
    5. Secondary Outcome
    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 55 52 51 40
    Positive
    0
    0
    1
    1
    Presence of abdominal pain
    0
    0
    0
    1
    15% increase in WBC from baseline
    0
    0
    0
    0
    Abdominal pain + 15% increase in WBC
    0
    0
    0
    0
    6. Secondary Outcome
    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 55 52 51 40
    Negative
    1
    0
    0
    0
    Presence of abdominal pain
    1
    0
    0
    0
    15% increase in WBC from baseline
    0
    0
    0
    0
    Abdominal pain + 15% increase in WBC
    0
    0
    0
    0
    7. Secondary Outcome
    Title Percent of Subjects Requiring Surgery for Diverticulitis
    Description
    Time Frame up to 104 Weeks

    Outcome Measure Data

    Analysis Population Description
    Full Analysis Set
    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 148 147 149 142
    Number [percentage of subjects]
    4.7
    2.7
    2.0
    1.4

    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 9/148 (6.1%) 13/147 (8.8%) 14/149 (9.4%) 15/142 (10.6%)
    Blood and lymphatic system disorders
    Agranulocytosis 0/148 (0%) 0/147 (0%) 1/149 (0.7%) 0/142 (0%)
    Cardiac disorders
    Angina pectoris 0/148 (0%) 1/147 (0.7%) 1/149 (0.7%) 1/142 (0.7%)
    Atrial fibrillation 1/148 (0.7%) 1/147 (0.7%) 0/149 (0%) 0/142 (0%)
    Cardiac failure 0/148 (0%) 0/147 (0%) 1/149 (0.7%) 0/142 (0%)
    Ventricular extrasystoles 0/148 (0%) 1/147 (0.7%) 0/149 (0%) 0/142 (0%)
    Supraventricular tachycardia 1/148 (0.7%) 0/147 (0%) 0/149 (0%) 0/142 (0%)
    Gastrointestinal disorders
    Gastroesophogeal reflux disease 0/148 (0%) 0/147 (0%) 1/149 (0.7%) 0/142 (0%)
    Small intestinal hemorrhage 0/148 (0%) 0/147 (0%) 1/149 (0.7%) 0/142 (0%)
    Abdominal pain 0/148 (0%) 1/147 (0.7%) 0/149 (0%) 1/142 (0.7%)
    Gastrointestinal hemorrhage 0/148 (0%) 1/147 (0.7%) 0/149 (0%) 0/142 (0%)
    Hiatus hernia 0/148 (0%) 1/147 (0.7%) 0/149 (0%) 0/142 (0%)
    Nausea 0/148 (0%) 1/147 (0.7%) 0/149 (0%) 0/142 (0%)
    Esophagitis 0/148 (0%) 1/147 (0.7%) 0/149 (0%) 0/142 (0%)
    Abdominal pain lower 0/148 (0%) 0/147 (0%) 0/149 (0%) 1/142 (0.7%)
    Abdominal pain upper 0/148 (0%) 0/147 (0%) 0/149 (0%) 1/142 (0.7%)
    Dyspepsia 0/148 (0%) 0/147 (0%) 0/149 (0%) 1/142 (0.7%)
    Mallory-Weiss syndrome 0/148 (0%) 0/147 (0%) 0/149 (0%) 1/142 (0.7%)
    General disorders
    Chest pain 0/148 (0%) 0/147 (0%) 2/149 (1.3%) 0/142 (0%)
    Multi-organ failure/Death 0/148 (0%) 1/147 (0.7%) 0/149 (0%) 0/142 (0%)
    Chest discomfort 1/148 (0.7%) 0/147 (0%) 0/149 (0%) 0/142 (0%)
    Hepatobiliary disorders
    Cholangitis acute 0/148 (0%) 0/147 (0%) 1/149 (0.7%) 0/142 (0%)
    Cholecystitis 0/148 (0%) 0/147 (0%) 0/149 (0%) 1/142 (0.7%)
    Infections and infestations
    Pneumonia 1/148 (0.7%) 0/147 (0%) 1/149 (0.7%) 2/142 (1.4%)
    Subcutaneous abscess 0/148 (0%) 0/147 (0%) 1/149 (0.7%) 0/142 (0%)
    Appendicitis 0/148 (0%) 1/147 (0.7%) 0/149 (0%) 0/142 (0%)
    Bronchitis 1/148 (0.7%) 0/147 (0%) 0/149 (0%) 0/142 (0%)
    Peridiverticular abscess 1/148 (0.7%) 0/147 (0%) 0/149 (0%) 0/142 (0%)
    Pharyngitis 1/148 (0.7%) 0/147 (0%) 0/149 (0%) 0/142 (0%)
    Borrelia infection 0/148 (0%) 0/147 (0%) 0/149 (0%) 1/142 (0.7%)
    Pneumonia viral 0/148 (0%) 0/147 (0%) 0/149 (0%) 1/142 (0.7%)
    Viral pericarditis 0/148 (0%) 0/147 (0%) 0/149 (0%) 1/142 (0.7%)
    Injury, poisoning and procedural complications
    Humerus fracture 0/148 (0%) 0/147 (0%) 1/149 (0.7%) 0/142 (0%)
    Ankle fracture 0/148 (0%) 1/147 (0.7%) 0/149 (0%) 0/142 (0%)
    Patella fracture 0/148 (0%) 1/147 (0.7%) 0/149 (0%) 0/142 (0%)
    Post procedural edema 0/148 (0%) 1/147 (0.7%) 0/149 (0%) 0/142 (0%)
    Radius fracture 0/148 (0%) 1/147 (0.7%) 0/149 (0%) 0/142 (0%)
    Hip fracture 1/148 (0.7%) 0/147 (0%) 0/149 (0%) 0/142 (0%)
    Metabolism and nutrition disorders
    Type 2 diabetes mellitus 0/148 (0%) 0/147 (0%) 1/149 (0.7%) 0/142 (0%)
    Musculoskeletal and connective tissue disorders
    Intervertebral disc protrusion 0/148 (0%) 1/147 (0.7%) 0/149 (0%) 0/142 (0%)
    Arthritis 0/148 (0%) 0/147 (0%) 0/149 (0%) 1/142 (0.7%)
    Rotator cuff syndrome 0/148 (0%) 0/147 (0%) 0/149 (0%) 1/142 (0.7%)
    Spinal column stenosis 0/148 (0%) 0/147 (0%) 0/149 (0%) 1/142 (0.7%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Ovarian granulosa-theca cell tumor 0/148 (0%) 0/147 (0%) 1/149 (0.7%) 0/142 (0%)
    Renal cell carcinoma 0/148 (0%) 0/147 (0%) 1/149 (0.7%) 0/142 (0%)
    Squamous cell carcinoma 0/148 (0%) 0/147 (0%) 1/149 (0.7%) 0/142 (0%)
    Breast cancer 0/148 (0%) 1/147 (0.7%) 0/149 (0%) 0/142 (0%)
    Cardiac neoplasm unspecified 0/148 (0%) 1/147 (0.7%) 0/149 (0%) 0/142 (0%)
    Prostate cancer 0/148 (0%) 1/147 (0.7%) 0/149 (0%) 0/142 (0%)
    Malignant melanoma 0/148 (0%) 0/147 (0%) 0/149 (0%) 1/142 (0.7%)
    Nervous system disorders
    Cerebrovascular accident 0/148 (0%) 2/147 (1.4%) 0/149 (0%) 0/142 (0%)
    Syncope 0/148 (0%) 0/147 (0%) 1/149 (0.7%) 0/142 (0%)
    Transient ischemic attack 1/148 (0.7%) 0/147 (0%) 0/149 (0%) 0/142 (0%)
    Psychiatric disorders
    Panic attack 0/148 (0%) 0/147 (0%) 0/149 (0%) 1/142 (0.7%)
    Reproductive system and breast disorders
    Ovarian cyst 0/148 (0%) 0/147 (0%) 1/149 (0.7%) 0/142 (0%)
    Uterovaginal prolapse 1/148 (0.7%) 0/147 (0%) 0/149 (0%) 0/142 (0%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnea 1/148 (0.7%) 0/147 (0%) 0/149 (0%) 1/142 (0.7%)
    Vascular disorders
    Hypotension 0/148 (0%) 1/147 (0.7%) 0/149 (0%) 0/142 (0%)
    Intra-abdominal hemorrhage 0/148 (0%) 1/147 (0.7%) 0/149 (0%) 0/142 (0%)
    Femoral arterial stenosis 0/148 (0%) 0/147 (0%) 0/149 (0%) 1/142 (0.7%)
    Hemorrhage 0/148 (0%) 0/147 (0%) 0/149 (0%) 1/142 (0.7%)
    Hypertension 0/148 (0%) 0/147 (0%) 0/149 (0%) 1/142 (0.7%)
    Thrombosis 0/148 (0%) 0/147 (0%) 0/149 (0%) 1/142 (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 108/148 (73%) 111/147 (75.5%) 110/149 (73.8%) 105/142 (73.9%)
    Gastrointestinal disorders
    Abdominal pain 19/148 (12.8%) 19/147 (12.9%) 15/149 (10.1%) 12/142 (8.5%)
    Diarrhea 15/148 (10.1%) 15/147 (10.2%) 18/149 (12.1%) 12/142 (8.5%)
    Nausea 5/148 (3.4%) 8/147 (5.4%) 10/149 (6.7%) 11/142 (7.7%)
    Dyspepsia 5/148 (3.4%) 11/147 (7.5%) 6/149 (4%) 6/142 (4.2%)
    Constipation 9/148 (6.1%) 6/147 (4.1%) 6/149 (4%) 12/142 (8.5%)
    Abdominal pain lower 5/148 (3.4%) 2/147 (1.4%) 10/149 (6.7%) 7/142 (4.9%)
    Infections and infestations
    Urinary tract infection 11/148 (7.4%) 14/147 (9.5%) 10/149 (6.7%) 7/142 (4.9%)
    Sinusitis 12/148 (8.1%) 8/147 (5.4%) 10/149 (6.7%) 11/142 (7.7%)
    Influenza 11/148 (7.4%) 8/147 (5.4%) 9/149 (6%) 11/142 (7.7%)
    Bronchitis 8/148 (5.4%) 7/147 (4.8%) 9/149 (6%) 7/142 (4.9%)
    Nasopharyngitis 5/148 (3.4%) 10/147 (6.8%) 8/149 (5.4%) 9/142 (6.3%)
    Musculoskeletal and connective tissue disorders
    Back pain 10/148 (6.8%) 11/147 (7.5%) 11/149 (7.4%) 12/142 (8.5%)
    Nervous system disorders
    Headache 14/148 (9.5%) 10/147 (6.8%) 14/149 (9.4%) 13/142 (9.2%)
    Respiratory, thoracic and mediastinal disorders
    Cough 9/148 (6.1%) 3/147 (2%) 4/149 (2.7%) 2/142 (1.4%)
    Vascular disorders
    Hypertension 6/148 (4.1%) 8/147 (5.4%) 2/149 (1.3%) 8/142 (5.6%)

    Limitations/Caveats

    [Not Specified]

    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
    Email ClinicalTransparency@shire.com
    Responsible Party:
    Shire
    ClinicalTrials.gov Identifier:
    NCT00545103
    Other Study ID Numbers:
    • SPD476-314
    • 2007-004896-20
    First Posted:
    Oct 17, 2007
    Last Update Posted:
    Jun 11, 2021
    Last Verified:
    May 1, 2021