Prevention of Recurrence of Diverticulitis | NCT00545103

ID	Type	Description	Link
2007-004896-20	EudraCT Number

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
SPD476 (1.2 g)	Experimental	Drug: SPD476, MMX™ mesalazine, 1.2g extended release tablet
SPD476 (2.4 g)	Experimental	Drug: SPD476, MMX™ mesalazine, 2.4g extended release tablet
SPD476 (4.8 g)	Experimental	Drug: SPD476, MMX™ mesalazine, 4.8g extended release tablet
Placebo	Placebo Comparator	Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
SPD476, MMX™ mesalazine, 1.2g extended release tablet	Drug	SPD476 1.2g administered Once Daily (QD)	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 Are 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
Birmingham Gastroenterology Associates, PC		Birmingham	Alabama	35209	United States
Alabama Clinical Therapeutics, LLC

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 592 subjects randomized, 6 were never dosed with investigational product. Therefore, 586 subjects are in the Safety Population.

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00057.8± 10.88 BG00154.2± 10.10 BG00256.7± 11.76 BG003

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

18 to < 35 years

Title	Measurements
	BG0001 BG001

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00083 BG001

Region of Enrollment

This baseline measure consists of all randomized subjects (n = 592).

Count of Participants

Participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00089 BG00188 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

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

Units	Counts
Participants	OG000148 OG001147 OG002149 OG003

Title

Denominators

Categories

Title	Measurements
	OG00062.8 OG00159.2 OG00269.1 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		0.778							95							Superiority or Other (legacy)
OG001 OG003		Cochran-Mantel-Haenszel		0.159

Secondary

Percent of Subjects Who Are 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

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

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

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

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	OG000

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	9	148	108	148
EG001	SPD476 (2.4 g)	2.4 g administered orally once daily	13	147	111	147
EG002	SPD476 (4.8 g)	4.8 g administered orally once daily	14	149	110	149
EG003	Placebo	Placebo administered orally once daily	15	142	105	142

Serious Adverse Events

Term	Organ System	Statistical Information
Agranulocytosis	Blood and lymphatic system disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0021 affected149 at risk EG0030 affected142 at risk
Angina pectoris	Cardiac disorders	EG0000 affected148 at risk EG0011 affected147 at risk EG0021 affected149 at risk EG003
Atrial fibrillation	Cardiac disorders	EG0001 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Cardiac failure	Cardiac disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0021 affected149 at risk EG003
Ventricular extrasystoles	Cardiac disorders	EG0000 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Supraventricular tachycardia	Cardiac disorders	EG0001 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Gastroesophogeal reflux disease	Gastrointestinal disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0021 affected149 at risk EG003
Small intestinal hemorrhage	Gastrointestinal disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0021 affected149 at risk EG003
Abdominal pain	Gastrointestinal disorders	EG0000 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Gastrointestinal hemorrhage	Gastrointestinal disorders	EG0000 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Hiatus hernia	Gastrointestinal disorders	EG0000 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Nausea	Gastrointestinal disorders	EG0000 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Esophagitis	Gastrointestinal disorders	EG0000 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Abdominal pain upper	Gastrointestinal disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Dyspepsia	Gastrointestinal disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Mallory-Weiss syndrome	Gastrointestinal disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Chest pain	General disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0022 affected149 at risk EG003
Multi-organ failure/Death	General disorders	EG0000 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Chest discomfort	General disorders	EG0001 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Cholangitis acute	Hepatobiliary disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0021 affected149 at risk EG003
Cholecystitis	Hepatobiliary disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Pneumonia	Infections and infestations	EG0001 affected148 at risk EG0010 affected147 at risk EG0021 affected149 at risk EG003
Subcutaneous abscess	Infections and infestations	EG0000 affected148 at risk EG0010 affected147 at risk EG0021 affected149 at risk EG003
Appendicitis	Infections and infestations	EG0000 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Bronchitis	Infections and infestations	EG0001 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Peridiverticular abscess	Infections and infestations	EG0001 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Pharyngitis	Infections and infestations	EG0001 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Borrelia infection	Infections and infestations	EG0000 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Pneumonia viral	Infections and infestations	EG0000 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Viral pericarditis	Infections and infestations	EG0000 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Humerus fracture	Injury, poisoning and procedural complications	EG0000 affected148 at risk EG0010 affected147 at risk EG0021 affected149 at risk EG003
Ankle fracture	Injury, poisoning and procedural complications	EG0000 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Patella fracture	Injury, poisoning and procedural complications	EG0000 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Post procedural edema	Injury, poisoning and procedural complications	EG0000 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Radius fracture	Injury, poisoning and procedural complications	EG0000 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Hip fracture	Injury, poisoning and procedural complications	EG0001 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Type 2 diabetes mellitus	Metabolism and nutrition disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0021 affected149 at risk EG003
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	EG0000 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Arthritis	Musculoskeletal and connective tissue disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Spinal column stenosis	Musculoskeletal and connective tissue disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Ovarian granulosa-theca cell tumor	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected148 at risk EG0010 affected147 at risk EG0021 affected149 at risk EG003
Renal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected148 at risk EG0010 affected147 at risk EG0021 affected149 at risk EG003
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected148 at risk EG0010 affected147 at risk EG0021 affected149 at risk EG003
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Cardiac neoplasm unspecified	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Cerebrovascular accident	Nervous system disorders	EG0000 affected148 at risk EG0012 affected147 at risk EG0020 affected149 at risk EG003
Syncope	Nervous system disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0021 affected149 at risk EG003
Transient ischemic attack	Nervous system disorders	EG0001 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Panic attack	Psychiatric disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Ovarian cyst	Reproductive system and breast disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0021 affected149 at risk EG003
Uterovaginal prolapse	Reproductive system and breast disorders	EG0001 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Dyspnea	Respiratory, thoracic and mediastinal disorders	EG0001 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Hypotension	Vascular disorders	EG0000 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Intra-abdominal hemorrhage	Vascular disorders	EG0000 affected148 at risk EG0011 affected147 at risk EG0020 affected149 at risk EG003
Femoral arterial stenosis	Vascular disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Hemorrhage	Vascular disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Hypertension	Vascular disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003
Thrombosis	Vascular disorders	EG0000 affected148 at risk EG0010 affected147 at risk EG0020 affected149 at risk EG003

Other Adverse Events

Term	Organ System	Statistical Information
Abdominal pain	Gastrointestinal disorders	EG00019 affected148 at risk EG00119 affected147 at risk EG00215 affected149 at risk EG00312 affected142 at risk
Diarrhea	Gastrointestinal disorders	EG00015 affected148 at risk EG00115 affected147 at risk EG00218 affected149 at risk EG003
Nausea	Gastrointestinal disorders	EG0005 affected148 at risk EG0018 affected147 at risk EG00210 affected149 at risk EG003
Dyspepsia	Gastrointestinal disorders	EG0005 affected148 at risk EG00111 affected147 at risk EG0026 affected149 at risk EG003
Constipation	Gastrointestinal disorders	EG0009 affected148 at risk EG0016 affected147 at risk EG0026 affected149 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	EG0005 affected148 at risk EG0012 affected147 at risk EG00210 affected149 at risk EG003
Urinary tract infection	Infections and infestations	EG00011 affected148 at risk EG00114 affected147 at risk EG00210 affected149 at risk EG003
Sinusitis	Infections and infestations	EG00012 affected148 at risk EG0018 affected147 at risk EG00210 affected149 at risk EG003
Influenza	Infections and infestations	EG00011 affected148 at risk EG0018 affected147 at risk EG0029 affected149 at risk EG003
Bronchitis	Infections and infestations	EG0008 affected148 at risk EG0017 affected147 at risk EG0029 affected149 at risk EG003
Nasopharyngitis	Infections and infestations	EG0005 affected148 at risk EG00110 affected147 at risk EG0028 affected149 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	EG00010 affected148 at risk EG00111 affected147 at risk EG00211 affected149 at risk EG003
Headache	Nervous system disorders	EG00014 affected148 at risk EG00110 affected147 at risk EG00214 affected149 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	EG0009 affected148 at risk EG0013 affected147 at risk EG0024 affected149 at risk EG003
Hypertension	Vascular disorders	EG0006 affected148 at risk EG0018 affected147 at risk EG0022 affected149 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