Prevention of Recurrence of Diverticulitis | NCT00545740

ID	Type	Description	Link
2007-004895-37	EudraCT Number

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Intervention Names
SPD476 (1.2 g)	Experimental	Drug: SPD476 (1.2g)
SPD476 (2.4 g)	Experimental	Drug: SPD476 (2.4 g)
SPD476 (4.8 g)	Experimental	Drug: SPD476 (4.8 g)
Placebo	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
SPD476 (1.2g)	Drug	1.2g SPD476 once daily (QD) orally	SPD476 (1.2 g)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	Up to 104 weeks

Secondary Outcomes

Measure	Description	Time Frame
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.	Up to 104 weeks

Eligibility Module

Name	Affiliation	Role
Study Director	Takeda	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Dedicated Clinical Research		Litchfield Park	Arizona	85340	United States
Lynn Institute of the Ozarks

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25038431	Derived	Raskin JB, Kamm MA, Jamal MM, Marquez J, Melzer E, Schoen RE, Szaloki T, Barrett K, Streck P. Mesalamine did not prevent recurrent diverticulitis in phase 3 controlled trials. Gastroenterology. 2014 Oct;147(4):793-802. doi: 10.1053/j.gastro.2014.07.004. Epub 2014 Jul 16.

Results Section

Participant Flow Module

ID	Title	Description
FG000	SPD476 (1.2 g)	1.2 g administered orally once daily
FG001	SPD476 (2.4 g)	2.4 g administered orally once daily

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	SPD476 (1.2 g)	1.2 g administered orally once daily
BG001	SPD476 (2.4 g)	2.4 g administered orally once daily
BG002	SPD476 (4.8 g)	4.8 g administered orally once daily
BG003	Placebo	Placebo administered orally once daily
BG004	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

The Safety Population was used for this baseline measure. The Safety Population consists of subjects who were randomized and took at least 1 dose of investigational product. Out of the 590 subjects randomized, 7 were never dosed with investigational product. Therefore, 583 subjects are in the Safety Population.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00055.1± 11.11 BG00154.5± 11.96 BG00254.5± 11.93 BG003

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

18 to <35 years

Title	Measurements
	BG0003 BG001

Sex/Gender, Customized

Count of Participants

Participants

Title

Denominators

Categories

Female

Title	Measurements
	BG00064 BG001

Region of Enrollment

This baseline measure consists of all randomized subjects (n = 590).

Count of Participants

Participants

Title

Denominators

Categories

Argentina

Title	Measurements
	BG0005 BG0013 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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.

Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.

Posted

Number

percentage of subjects

Up to 104 weeks

ID	Title	Description
OG000	SPD476 (1.2 g)	1.2 g administered orally once daily
OG001	SPD476 (2.4 g)	2.4 g administered orally once daily
OG002	SPD476 (4.8 g)	4.8 g administered orally once daily
OG003	Placebo	Placebo administered orally once daily

Units	Counts
Participants	OG000143 OG001143 OG002150 OG003

Title

Denominators

Categories

Title	Measurements
	OG00061.5 OG00162.2 OG00252.7 OG003

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG002 OG003		Cochran-Mantel-Haenszel		0.063							95							Superiority or Other (legacy)
OG001 OG003		Cochran-Mantel-Haenszel		0.736

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.

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.

Posted

Number

Number of CT scans

Up to 104 weeks

ID	Title	Description
OG000	SPD476 (1.2 g)	1.2 g administered orally once daily
OG001	SPD476 (2.4 g)	2.4 g administered orally once daily
OG002	SPD476 (4.8 g)	4.8 g administered orally once daily
OG003	Placebo	Placebo administered orally once daily

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.

Full Analysis Set (FAS) consists of all subjects who were randomized and took at least 1 dose of investigational product.

Posted

Number

percentage of subjects

Up to 104 weeks

ID	Title	Description
OG000	SPD476 (1.2 g)	1.2 g administered orally once daily
OG001	SPD476 (2.4 g)	2.4 g administered orally once daily
OG002	SPD476 (4.8 g)	4.8 g administered orally once daily
OG003	Placebo	Placebo administered orally once daily

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.

Posted

Number

Number of CT scans

Up to 104 weeks

ID	Title	Description
OG000	SPD476 (1.2 g)	1.2 g administered orally once daily
OG001	SPD476 (2.4 g)	2.4 g administered orally once daily
OG002	SPD476 (4.8 g)	4.8 g administered orally once daily
OG003	Placebo	Placebo administered orally once daily

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.

Posted

Number

Number of CT scans

Up to 104 weeks

ID	Title	Description
OG000	SPD476 (1.2 g)	1.2 g administered orally once daily
OG001	SPD476 (2.4 g)	2.4 g administered orally once daily
OG002	SPD476 (4.8 g)	4.8 g administered orally once daily
OG003	Placebo	Placebo administered orally once daily

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.

Posted

Number

Number of CT scans

Up to 104 weeks

ID	Title	Description
OG000	SPD476 (1.2 g)	1.2 g administered orally once daily
OG001	SPD476 (2.4 g)	2.4 g administered orally once daily
OG002	SPD476 (4.8 g)	4.8 g administered orally once daily
OG003	Placebo	Placebo administered orally once daily

Secondary

Percent of Subjects Requiring Surgery for Diverticulitis

Full Analysis Set consists of all subjects who were randomized and took at least 1 dose of investigational product.

Posted

Number

percentage of subjects

Up to 104 weeks

ID	Title	Description
OG000	SPD476 (1.2 g)	1.2 g administered orally once daily
OG001	SPD476 (2.4 g)	2.4 g administered orally once daily
OG002	SPD476 (4.8 g)	4.8 g administered orally once daily
OG003	Placebo	Placebo administered orally once daily

Units	Counts
Participants

Arm/Groups

ID	Title	Description	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	SPD476 (1.2 g)	1.2 g administered orally once daily	16	143	109	143
EG001	SPD476 (2.4 g)	2.4 g administered orally once daily	15	143	106	143
EG002	SPD476 (4.8 g)	4.8 g administered orally once daily	18	150	101	150
EG003	Placebo	Placebo administered orally once daily	16	147	112	147

Serious Adverse Events

Term	Organ System	Statistical Information
Iron deficiency anemia	Blood and lymphatic system disorders	EG0000 affected143 at risk EG0011 affected143 at risk EG0020 affected150 at risk EG0030 affected147 at risk
Angina pectoris	Cardiac disorders	EG0002 affected143 at risk EG0011 affected143 at risk EG0021 affected150 at risk EG003
Coronary artery disease	Cardiac disorders	EG0000 affected143 at risk EG0011 affected143 at risk EG0020 affected150 at risk EG003
Myocardial ischemia	Cardiac disorders	EG0000 affected143 at risk EG0011 affected143 at risk EG0020 affected150 at risk EG003
Acute myocarcial infarction	Cardiac disorders	EG0001 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Coronary artery insufficiency	Cardiac disorders	EG0001 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Vertigo positional	Ear and labyrinth disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Autoimmune thyroiditis	Endocrine disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Retinal detachment	Eye disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Dyspepsia	Gastrointestinal disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0021 affected150 at risk EG003
Gastritis	Gastrointestinal disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0021 affected150 at risk EG003
Pancreatitis	Gastrointestinal disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0021 affected150 at risk EG003
Pancreatitis acute	Gastrointestinal disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0021 affected150 at risk EG003
Enterovesical fistula	Gastrointestinal disorders	EG0000 affected143 at risk EG0011 affected143 at risk EG0020 affected150 at risk EG003
Gastrointestinal hemorrhage	Gastrointestinal disorders	EG0000 affected143 at risk EG0011 affected143 at risk EG0020 affected150 at risk EG003
Abdominal pain	Gastrointestinal disorders	EG0001 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Large intestine perforation	Gastrointestinal disorders	EG0001 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Peritoneal hematoma	Gastrointestinal disorders	EG0001 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Pyrexia	General disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0021 affected150 at risk EG003
Chills	General disorders	EG0000 affected143 at risk EG0011 affected143 at risk EG0020 affected150 at risk EG003
Non-cardiac chest pain	General disorders	EG0001 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Urinary tract infection	Infections and infestations	EG0000 affected143 at risk EG0010 affected143 at risk EG0022 affected150 at risk EG003
Gastroenteritis	Infections and infestations	EG0000 affected143 at risk EG0011 affected143 at risk EG0021 affected150 at risk EG003
Sepsis	Infections and infestations	EG0001 affected143 at risk EG0010 affected143 at risk EG0021 affected150 at risk EG003
Clostridial infection	Infections and infestations	EG0000 affected143 at risk EG0010 affected143 at risk EG0021 affected150 at risk EG003
Kidney infection	Infections and infestations	EG0000 affected143 at risk EG0010 affected143 at risk EG0021 affected150 at risk EG003
Pneumonia primary atypical	Infections and infestations	EG0000 affected143 at risk EG0010 affected143 at risk EG0021 affected150 at risk EG003
Viral infection	Infections and infestations	EG0000 affected143 at risk EG0010 affected143 at risk EG0021 affected150 at risk EG003
Cellulitis	Infections and infestations	EG0000 affected143 at risk EG0011 affected143 at risk EG0020 affected150 at risk EG003
Pneumonia	Infections and infestations	EG0001 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Endophthalmitis	Infections and infestations	EG0000 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Gastrointestinal infection	Infections and infestations	EG0000 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Road traffic accident	Injury, poisoning and procedural complications	EG0002 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Near drowning	Injury, poisoning and procedural complications	EG0000 affected143 at risk EG0010 affected143 at risk EG0021 affected150 at risk EG003
Concussion	Injury, poisoning and procedural complications	EG0001 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Femoral neck fracture	Injury, poisoning and procedural complications	EG0001 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Skin injury	Injury, poisoning and procedural complications	EG0001 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	EG0000 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Joint dislocation	Injury, poisoning and procedural complications	EG0000 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Hypercalcemia	Metabolism and nutrition disorders	EG0001 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Uterine cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0002 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected143 at risk EG0010 affected143 at risk EG0021 affected150 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected143 at risk EG0011 affected143 at risk EG0020 affected150 at risk EG003
Thyroid neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0001 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Breast cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Laryngeal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Ischemic stroke	Nervous system disorders	EG0000 affected143 at risk EG0011 affected143 at risk EG0020 affected150 at risk EG003
Movement disorder	Nervous system disorders	EG0000 affected143 at risk EG0011 affected143 at risk EG0020 affected150 at risk EG003
Syncope	Nervous system disorders	EG0000 affected143 at risk EG0011 affected143 at risk EG0020 affected150 at risk EG003
Cerebral ischemia	Nervous system disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Alcoholism	Psychiatric disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0021 affected150 at risk EG003
Bipolar II disorder	Psychiatric disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0021 affected150 at risk EG003
Confusional state	Psychiatric disorders	EG0000 affected143 at risk EG0011 affected143 at risk EG0020 affected150 at risk EG003
Bipolar disorder	Psychiatric disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Nephrolithiasis	Renal and urinary disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0021 affected150 at risk EG003
Pelvi-ureteric obstruction	Renal and urinary disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0021 affected150 at risk EG003
Bladder prolapse	Renal and urinary disorders	EG0000 affected143 at risk EG0011 affected143 at risk EG0020 affected150 at risk EG003
Renal colic	Renal and urinary disorders	EG0001 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Renal failure acute	Renal and urinary disorders	EG0001 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Stress urinary incontinence	Renal and urinary disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Benign prostatic hyperplasia	Reproductive system and breast disorders	EG0000 affected143 at risk EG0011 affected143 at risk EG0020 affected150 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	EG0001 affected143 at risk EG0010 affected143 at risk EG0021 affected150 at risk EG003
Nasal septum deviation	Respiratory, thoracic and mediastinal disorders	EG0000 affected143 at risk EG0011 affected143 at risk EG0020 affected150 at risk EG003
Sinus polyp	Respiratory, thoracic and mediastinal disorders	EG0000 affected143 at risk EG0011 affected143 at risk EG0020 affected150 at risk EG003
Pulmonary hypertension	Respiratory, thoracic and mediastinal disorders	EG0001 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Asthma	Respiratory, thoracic and mediastinal disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Aortic Aneurysm	Vascular disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003
Hypertension	Vascular disorders	EG0000 affected143 at risk EG0010 affected143 at risk EG0020 affected150 at risk EG003

Other Adverse Events

Term	Organ System	Statistical Information
Abdominal pain	Gastrointestinal disorders	EG00017 affected143 at risk EG00116 affected143 at risk EG00218 affected150 at risk EG00316 affected147 at risk
Diarrhea	Gastrointestinal disorders	EG00013 affected143 at risk EG00112 affected143 at risk EG00212 affected150 at risk EG003
Nausea	General disorders	EG00010 affected143 at risk EG0011 affected143 at risk EG0026 affected150 at risk EG003
Flatulence	Gastrointestinal disorders	EG0009 affected143 at risk EG0015 affected143 at risk EG0023 affected150 at risk EG003
Constpation	Gastrointestinal disorders	EG0007 affected143 at risk EG0013 affected143 at risk EG0025 affected150 at risk EG003
Urinary tract infection	Infections and infestations	EG00014 affected143 at risk EG00112 affected143 at risk EG0028 affected150 at risk EG003
Nasopharyngitis	Infections and infestations	EG0006 affected143 at risk EG00115 affected143 at risk EG0027 affected150 at risk EG003
Upper respiratory tract infection	Infections and infestations	EG0009 affected143 at risk EG0013 affected143 at risk EG00210 affected150 at risk EG003
Sinusitis	Infections and infestations	EG0009 affected143 at risk EG0017 affected143 at risk EG0025 affected150 at risk EG003
Influenza	Infections and infestations	EG0005 affected143 at risk EG00111 affected143 at risk EG0024 affected150 at risk EG003
Bronchitis	Infections and infestations	EG0007 affected143 at risk EG0018 affected143 at risk EG0023 affected150 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	EG0008 affected143 at risk EG0015 affected143 at risk EG0028 affected150 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	EG0007 affected143 at risk EG0015 affected143 at risk EG0024 affected150 at risk EG003
Headache	Nervous system disorders	EG00013 affected143 at risk EG0016 affected143 at risk EG00214 affected150 at risk EG003
Hypertension	Vascular disorders	EG0005 affected143 at risk EG0018 affected143 at risk EG0026 affected150 at risk EG003

ID	Term
D000076385	Diverticular Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D062368	meta-Aminobenzoates
D062365	Aminobenzoates
D001565	Benzoates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D000636	Aminosalicylic Acids
D012459	Salicylates
D062385	Hydroxybenzoates
D006880	Hydroxy Acids
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic
D006838	Hydrocarbons
D010636	Phenols