Assessing the Safety/Efficacy of Asacol® Given Every 12 H... | NCT00713310

NCT00713310

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Low-Dose	Experimental	1.2 - 2.4 g/day Asacol dependent on body weight	Drug: Asacol 400 mg
High-Dose	Experimental	2.0 - 4.8 g/day Asacol dependent on body weight	Drug: Asacol 400 mg

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Asacol 400 mg	Drug	High dose: 17-<33 kg = 3 Asacol 400mg in morning and 2 Asacol 400 in PM, 33-<54 kg = 5 Asacol 400mg in morning and 4 Asacol 400 in PM, 54-<90 kg = 6 Asacol 400mg in morning and 6 Asacol 400 in PM

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population	PUCAI 0-85, abdominal pain (no pain/0, pain ignored/5, pain not ignored/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)	Baseline and 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT	PUCAI 0-85, abdominal pain amended (no pain/0, very mild/2.5, mild/5, moderate/7.5, severe/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Preston M Dunnmon, MD	Procter and Gamble	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Facility		Birmingham	Alabama	35233	United States
Research Facility

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25419597	Derived	Winter HS, Krzeski P, Heyman MB, Ibarguen-Secchia E, Iwanczak B, Kaczmarski M, Kierkus J, Kolacek S, Osuntokun B, Quiros JA, Shah M, Yacyshyn B, Dunnmon PM. High- and low-dose oral delayed-release mesalamine in children with mild-to-moderately active ulcerative colitis. J Pediatr Gastroenterol Nutr. 2014 Dec;59(6):767-72. doi: 10.1097/MPG.0000000000000530.

IPD Sharing Statement Module

No data available

No data is available for this block.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Low-Dose	17-<33kg: AM - 2 Asacol 400mg & 1 placebo, PM - 1 Asacol 400mg & 1 placebo; 33-<54kg: AM - 3 Asacol 400mg & 2 placebo, PM - 2 Asacol 400mg & 2 placebo; 54-<90kg: AM & PM - 3 Asacol 400mg & 3 placebo
FG001	High-Dose

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Low-Dose	17-<33kg: AM - 2 Asacol 400mg & 1 placebo, PM - 1 Asacol 400mg & 1 placebo; 33-<54kg: AM - 3 Asacol 400mg & 2 placebo, PM - 2 Asacol 400mg & 2 placebo; 54-<90kg: AM & PM - 3 Asacol 400mg & 3 placebo
BG001	High-Dose	17-<33kg: AM 3 Asacol 400mg, PM 2 Asacol 400mg; 33-<54kg: AM5 Asacol 400mg, PM 4 Asacol 400mg; 54-<90kg: AM & PM 6 Asacol 400mg
BG002	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

mITT Population

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00013.0± 3.2 BG00112.8± 3.0 BG00212.9± 3.1

Age, Customized

Number

participants

Title

Denominators

Categories

5-8 years

Title	Measurements
	BG0004 BG0014 BG002

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG00022 BG00123 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00026 BG00123 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

Treatment Success PUCAI (Pediatric Ulcerative Colitis Activity Index), mITT/Modified Intent to Treat Population

PUCAI 0-85, abdominal pain (no pain/0, pain ignored/5, pain not ignored/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)

miTT includes subjects who were randomized and took at least one dose of study medication

Posted

Number

% participants with treatment success

Baseline and 6 weeks

ID	Title	Description
OG000	Low Dose	Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
OG001	High Dose	High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)

Units	Counts
Participants	OG00041 OG00141

Title

Denominators

Categories

Title	Measurements
	OG00056.1 OG00155.0

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
OG000 OG001	A total of about 100 subjects were to be enrolled in the study with the expectation that about 80 subjects (40/dose level) would complete. Minimum of 9 subjects in 5-8 year old range were to be enrolled, 4-5 per dose level (high/low). A 2-sided α=0.05 Fisher's Exact test has an estimated power of P=0.50 with 40 subjects per dose level.	Cochran-Mantel-Haenszel		0.9240		High-Low Dose Difference Success Rates	-1.1			2-Sided	95	-22.7	20.5				No	Superiority or Other

Secondary

Treatment Success PUCAI Amended Endpoint (5 Point Scale Abdominal Pain), mITT

PUCAI 0-85, abdominal pain amended (no pain/0, very mild/2.5, mild/5, moderate/7.5, severe/10), rectal bleeding (none/0, small <50% stool/10, small with most stools/20, large >50% stool/30), stool consistency (formed/0, partially/5, unformed/10), # per 24 hrs (0-2/0, 3-5/5, 6-8/10, >8/15), nocturnal bowel movements (no/0, yes/10), activity level (no limitation/0, occasional limitation/5, severely restricted/10) Remission <10, Mild 10-34, Moderate 35-64, Severe 65-85, Success score<10 at Wk 6 (complete) or reduction of >=20 points baseline to Wk 6 with Wk 6 score>=10 (partial)

mITT subjects who were randomized & took at least one dose of study medication

Posted

Number

% participants with treatment success

Baseline and Week 6

ID	Title	Description
OG000	Low Dose	Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)
OG001	High Dose	High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Low Dose	Low Dose = Asacol 1.2 - 2.4 g/day stratified based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)			5	41	20	50
EG001	High Dose	High Dose = Asacol 2.0 - 4.8 g/day based on weight (17-<33 kg, 33-<54 kg, 54-90 kg) & disease severity (mild/moderate)			2	41	15	41

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Sinusitis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected41 at risk
Abdominal Pain	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected41 at risk
Body Mass Index Decreased	Investigations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected41 at risk
Colitis Ulcerative	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected41 at risk EG0011 events1 affected41 at risk
Adenovirus Infection	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected41 at risk
Diarrhoea Haemorrhagic	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected41 at risk
Cholangitis Sclerosing	Hepatobiliary disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected41 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected41 at risk EG0010 events0 affected41 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected41 at risk
Syncope	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected41 at risk EG0011 events1 affected41 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Colitis Ulcerative	Gastrointestinal disorders	MedDRA (13.0)	Systematic Assessment	EG0005 events5 affected50 at risk EG0012 events2 affected41 at risk
Fatigue	General disorders	MedDRA (13.0)	Systematic Assessment	EG0001 events1 affected50 at risk EG0013 events3 affected41 at risk
Pyrexia	General disorders	MedDRA (13.0)	Systematic Assessment	EG0000 events0 affected50 at risk EG0013 events3 affected41 at risk
Nasopharyngitis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0004 events4 affected50 at risk EG0014 events4 affected41 at risk
Sinusitis	Infections and infestations	MedDRA (13.0)	Systematic Assessment	EG0003 events3 affected50 at risk EG0010 events0 affected41 at risk
Dizziness	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0003 events3 affected50 at risk EG0011 events1 affected41 at risk
Headache	Nervous system disorders	MedDRA (13.0)	Systematic Assessment	EG0004 events4 affected50 at risk EG0012 events2 affected41 at risk

ID	Term
D003093	Colitis, Ulcerative

Ancestor Terms

ID	Term
D003092	Colitis
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases
D015212	Inflammatory Bowel Diseases
D003108	Colonic Diseases
D007410	Intestinal Diseases

ID	Term
D019804	Mesalamine

Ancestor Terms

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