A Comparison of Once a Day Dose Compared to 2 Doses/Day | NCT00505778

NCT00505778

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
Mesalamine (Asacol) Once-Daily	Active Comparator	an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)	Drug: Mesalamine Once-Daily
Mesalamine (Asacol) Twice-Daily	Active Comparator	an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)	Drug: Mesalamine Twice-Daily

Name	Type	Description	Arm Group Labels	Other Names
Mesalamine Once-Daily	Drug	Mesalamine tablets, 1.6-2.4 g/day taken orally once a day for 52 weeks	Mesalamine (Asacol) Once-Daily

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI)	Remission defined as SCCAI <5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).	6 months

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Patients Remaining in Remission at Month 3, ITT Population	Remission defined as SCCAI < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Tom G Todaro, MD	Procter and Gamble	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Research Facility		Athens	Alabama	35611	United States
Research Facility

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20064514	Derived	Sandborn WJ, Korzenik J, Lashner B, Leighton JA, Mahadevan U, Marion JF, Safdi M, Sninsky CA, Patel RM, Friedenberg KA, Dunnmon P, Ramsey D, Kane S. Once-daily dosing of delayed-release oral mesalamine (400-mg tablet) is as effective as twice-daily dosing for maintenance of remission of ulcerative colitis. Gastroenterology. 2010 Apr;138(4):1286-96, 1296.e1-3. doi: 10.1053/j.gastro.2009.12.054. Epub 2010 Jan 11.

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	Mesalamine Once-Daily	an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
FG001	Mesalamine Twice-Daily	an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)

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

No data available

No data is available for this block.

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Mesalamine Once-Daily	an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
BG001	Mesalamine Twice-Daily	an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
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, Customized

ITT Population

Number

Participants

Title

Denominators

Categories

< 65 years old

Title	Measurements
	BG000409 BG001414 BG002823

> = 65 years old

Gender

ITT Population

Number

participants

Title

Denominators

Categories

Female

Title	Measurements
	BG000261 BG001268 BG002

Region of Enrollment

ITT Population

Number

participants

Title

Denominators

Categories

Canada

Title	Measurements
	BG0006 BG0018 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

Percentage of Patients Remaining in Remission at Month 6, ITT Population, Determined by the Simple Clinical Colitis Activity Index (SCCAI)

Remission defined as SCCAI <5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).

ITT Population

Posted

Number

Percentage of Participants

6 months

ID	Title	Description
OG000	Mesalamine Once-Daily	an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
OG001	Mesalamine Twice-Daily	an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)

Units	Counts
Participants	OG000512 OG001511

Title

Denominators

Categories

Title	Measurements
	OG00090.5 OG00191.8

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	Assumed true remission rate is 70% with no difference in remission rates between QD and BID dosing.The non-inferiority margin used in hypothesis testing was set to 10%.	Cochran-Mantel-Haenszel	Stratified by prior Asacol dose Category	0.5016		BID-QD Difference in Remission Rates	1.3			2-Sided	95	-2.3	4.9				Yes	Non-Inferiority or Equivalence	To establish non-inferiority for primary efficacy variable at 2-sided upper confidence bound of 95% with 90% power, 442 patients per treatment group were required to be analyzable for primary efficacy analysis. Assuming 10% enrolled would not be analyzable, 1000 patients would be enrolled. If the 95% confidence interval's upper bound interval for the difference between the Asacol BID and Asacol QD group is <10%, then non-inferiority of Asacol QD is claimed.

Secondary

Percentage of Patients Remaining in Remission at Month 3, ITT Population

Remission defined as SCCAI < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).

ITT Population

Posted

Number

Percentage of Participants

3 months

ID	Title	Description
OG000	Mesalamine Once-Daily	an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
OG001	Mesalamine Twice-Daily	an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)

Units	Counts
Participants	OG000

Secondary

Percentage of Patients Remaining in Remission at Month 12, ITT Population

Remission defined as SCCAI score < 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).

ITT Population

Posted

Number

Percentage of Participants

12 months

ID	Title	Description
OG000	Mesalamine Once-Daily	an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
OG001	Mesalamine Twice-Daily	an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)

Units	Counts
Participants	OG000

Secondary

Number of Subjects Who Relapse/Flare Within 6 Months, ITT Population

Relapse/flare is defined as SCCAI >= 5. Simple Clinical Colitis Activity Index: minimum score 0, maximum score 19, reflects disease activity over the 24 hours prior to completion. Composite Score: bowel frequency (day, 0-3) (night, 0-2), defecation urgency (0-3), blood in stool (0-3), general well being (0-4), extracolonic features (arthritis, pyoderma gangrenosum, erythema nodosum, uveitis - 1 per manifestation).

ITT Population

Posted

Number

Participants

6 months

ID	Title	Description
OG000	Mesalamine Once-Daily	an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
OG001	Mesalamine Twice-Daily	an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)

Units	Counts
Participants	OG000

Secondary

Total MARS (Medication Adherence Report Scale) Questionnaire Scores, ITT Population, Month 6

MARS: Composite score for the following statements: I change how many times per day I take my medicine, I forget to use it, I stop taking it for a while, I only use it when I am having active symptoms, I decide to miss out on a dose, I take less than instructed, I take more than instructed, I avoid using it if I can, I use it regularly every day (reverse scored): 5-never, 4-rarely, 3-sometimes, 2-often, 1-very often. Minimum score 9, maximum score 45.

ITT Population

Posted

Mean

Standard Error

MARS Score

6 months

ID	Title	Description
OG000	Mesalamine Once-Daily	an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
OG001	Mesalamine Twice-Daily	an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)

Units	Counts
Participants	OG000

Secondary

Percentage of Participants Indicating Ulcerative Colitis in Remission (Patient Defined Remission Index), ITT Population, Month 6

Is your ulcerative colitis in remission (not active)? Y/N

ITT Population

Posted

Number

Percentage of Participants

6 months

ID	Title	Description
OG000	Mesalamine Once-Daily	an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
OG001	Mesalamine Twice-Daily	an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)

Units	Counts
Participants	OG000

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	Mesalamine Once-Daily	an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)			18	512	0	512
EG001	Mesalamine Twice-Daily	an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)			9	511	0	511

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal Pain	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected512 at risk EG0011 affected511 at risk
Ascites	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected512 at risk EG0011 affected511 at risk
Constipation	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected512 at risk EG0011 affected511 at risk
Rectal Haemorrhage	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected512 at risk EG0011 affected511 at risk
Anal fistula	Gastrointestinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Breast Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected512 at risk EG0011 affected511 at risk
Oesophageal Carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected512 at risk EG0011 affected511 at risk
Small Cell Lung Cancer Metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0000 affected512 at risk EG0011 affected511 at risk
Renal Cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Thyroid Neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Uterine Leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Cardiomyopathy	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected512 at risk EG0011 affected511 at risk
Coronary Artery Disease	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected512 at risk EG0011 affected511 at risk
Atrial Fibrillation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Cardiac Failure Congestive	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Myocardial Infarcation	Cardiac disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Renal Failure Acute	Renal and urinary disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected512 at risk EG0012 affected511 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected512 at risk EG0011 affected511 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Pulmonary Embolism	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected512 at risk EG0011 affected511 at risk
Haemothorax	Respiratory, thoracic and mediastinal disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Deep Vein Thrombosis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0000 affected512 at risk EG0011 affected511 at risk
Hypertension	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Thrombophlebitis	Vascular disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Cholangitis	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0002 affected512 at risk EG0010 affected511 at risk
Jaundice Cholestatic	Hepatobiliary disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Appendicitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0002 affected512 at risk EG0010 affected511 at risk
Diverticulitis	Infections and infestations	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Clavicle Fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Rib Fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Spinal Compression Fracture	Injury, poisoning and procedural complications	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Altered State of Consciousness	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Convulsion	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Transient Ischaemic Attack	Nervous system disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 at risk
Chest Pain	General disorders	MedDRA (10.0)	Systematic Assessment	EG0001 affected512 at risk EG0010 affected511 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

Title	Measurements
	BG000103 BG00197 BG002200