Ability to Maintain or Achieve Clinical and Endoscopic Re... | NCT01124149

ID	Type	Description	Link
2009-017044-13	EudraCT Number

Status Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Label	Type	Description	Intervention Names
MMX mesalamine/ mesalazine	Experimental		Drug: MMX mesalamine/ mesalazine

Name	Type	Description	Arm Group Labels	Other Names
MMX mesalamine/ mesalazine	Drug	4.8g/day given QD (four 1.2g tablets) for 8 weeks, 2.4g/day given QD (two 1.2g tablets) for 12 months	MMX mesalamine/ mesalazine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Subjects in Complete Remission at Month 12 of Maintenance Phase	Complete remission was defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).	12 months

Secondary Outcomes

Measure	Description	Time Frame
Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase	Clinical remission was defined as a score of 0 for rectal bleeding and stool frequency. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).

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
Advanced Clinical Research Institute

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32801008	Derived	Stevens TW, Gecse K, Turner JR, de Hertogh G, Rubin DT, D'Haens GR. Diagnostic Accuracy of Fecal Calprotectin Concentration in Evaluating Therapeutic Outcomes of Patients With Ulcerative Colitis. Clin Gastroenterol Hepatol. 2021 Nov;19(11):2333-2342. doi: 10.1016/j.cgh.2020.08.019. Epub 2020 Aug 13.
30294708	Derived

IPD Sharing Statement Module

Results Section

Participant Flow Module

ID	Title	Description
FG000	MMX Mesalamine/ Mesalazine	4.8g/day given QD for 8 weeks in the Acute Phase and 2.4g/day given QD for 12 months in the Maintenance Phase

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00042.9± 13.97

Age, Customized

Count of Participants

Participants

Title

Denominators

Categories

>=65 years

Title	Measurements
	BG00051

<=18 years

Title	Measurements
	BG000

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000308
Male	BG000409

Region of Enrollment

All enrolled subjects (n=722).

Count of Participants

Participants

Title

Denominators

Categories

BELGIUM

Title	Measurements
	BG00022

CANADA

Title	Measurements
	BG000

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 Subjects in Complete Remission at Month 12 of Maintenance Phase

Complete remission was defined as a modified Ulcerative Colitis Disease Activity Index (UC-DAI) <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).

Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.

Posted

Number

percentage of subjects

12 months

ID	Title	Description
OG000	MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)	Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
OG001	MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)	Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.

Units	Counts
Participants	OG000182 OG001277

Title

Denominators

Categories

Title	Measurements
	OG00047.8 OG00126.0

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		Regression, Logistic		<0.001		Odds Ratio (OR)	2.61			2-Sided	95	1.76	3.87					Superiority or Other (legacy)

Secondary

Percentage of Subjects in Clinical Remission at Month 12 of Maintenance Phase

Clinical remission was defined as a score of 0 for rectal bleeding and stool frequency. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).

Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.

Posted

Number

percentage of subjects

12 months

ID	Title	Description
OG000	MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)	Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
OG001	MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)	Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.

Secondary

Relapse in Ulcerative Colitis at Month 12 of Maintenance Phase

Relapse was defined in the Maintenance Phase as the need for alternative treatment for UC (including surgery); subjects were classified as having a relapse if they had withdrawn from the study due to a lack of efficacy.

Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.

Posted

Number

percentage of subjects

12 months

ID	Title	Description
OG000	MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)	Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
OG001	MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)	Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.

Secondary

Percentage of Subjects With Mucosal Healing at 12 Months of Maintenance Phase

Subjects with mucosal healing were defined as subjects who had an endoscopy score <=1. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe).

Maintenance Phase Efficacy Population included all subjects who, during the Maintenance Phase, took at least 1 dose of investigational product and had at least 1 post-dose efficacy assessment.

Posted

Number

percentage of subjects

12 months

ID	Title	Description
OG000	MMX Mesalamine/ Mesalazine (Complete Remission Acute Phase)	Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having complete remission at the end of the Acute Phase. Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.
OG001	MMX Mesalamine/ Mesalazine (Partial Remission Acute Phase)	Subjects received 4.8g/day given QD for 8 weeks in the Acute Phase and were classified as having partial remission at the end of the Acute Phase. Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. These subjects then received 2.4g/day given QD for 12 months in the Maintenance Phase.

Secondary

Improvement in Rectal Bleeding Score During the Acute Phase

Improvement was defined as at least a 1-point reduction in the rectal bleeding score from baseline at each assessment point. Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood).

Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.

Posted

Number

percentage of subjects

3 and 8 weeks

ID	Title	Description
OG000	MMX Mesalamine/ Mesalazine	4.8g/day given QD for 8 weeks in the Acute Phase

Units	Counts
Participants	OG000

Secondary

Improvement in Stool Frequency Symptoms During the Acute Phase

Improvement was defined as at least a 1-point reduction in the stool frequency score from baseline at each assessment point. Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).

Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.

Posted

Number

percentage of subjects

3 and 8 weeks

ID	Title	Description
OG000	MMX Mesalamine/ Mesalazine	4.8g/day given QD for 8 weeks in the Acute Phase

Units	Counts
Participants	OG000

Secondary

Percentage of Subjects in Complete Remission at Week 8 of Acute Phase

Complete (clinical and endoscopic) remission was defined as a modified UC-DAI <=1 with a score of 0 for rectal bleeding and stool frequency and at least a 1-point reduction in endoscopy score from baseline. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).

Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.

Posted

Number

percentage of subjects

8 Weeks

ID	Title	Description
OG000	MMX Mesalamine/ Mesalazine	4.8g/day given QD for 8 weeks in the Acute Phase

Units	Counts
Participants

Secondary

Percentage of Subjects in Partial Remission at Week 8 of Acute Phase

Partial remission was defined as a modified UC-DAI <=3 with a combined stool frequency and rectal bleeding score of <=1 and not in complete remission. The modified UC-DAI score is the sum of the scores of 4 parameters (stool frequency, rectal bleeding, endoscopy score, and physician global assessment), each scoring between 0 and 3, making 12 the worst score. Endoscopy score (mucosal appearance) ranges from 0-3 (0 = normal, 1 = mild , 2 = moderate, 3 = severe). Rectal bleeding is assessed on a scale from 0-3 (0 = no rectal bleeding, 1 = streaks of blood, 2 = obvious blood, 3 = mostly blood). Stool frequency is assessed on a scale of 0-2 (0 = 0-1 more than normal per day, 1 = 2-3 more than normal per day, 2 = 4 or more than normal per day).

Acute Phase Safety Population included all subjects who, during the Acute Phase, took at least 1 dose of investigational product.

Posted

Number

percentage of subjects

8 weeks

ID	Title	Description
OG000	MMX Mesalamine/ Mesalazine	4.8g/day given QD for 8 weeks in the Acute Phase

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	MMX Mesalamine/ Mesalazine (Acute Phase)	4.8g/day given QD for 8 weeks in the Acute Phase			13	717	60	717
EG001	MMX Mesalamine/ Mesalazine (Maintenance Phase)	2.4 g/day given QD for 12 months in the Maintenance Phase			14	461	65	461

Serious Adverse Events

Term	Organ System	Statistical Information
Myocardial infarction	Cardiac disorders	EG0001 affected717 at risk EG0010 affected461 at risk
Colitis ulcerative	Gastrointestinal disorders	EG0002 affected717 at risk EG0011 affected461 at risk
Pancreatitis acute	Gastrointestinal disorders	EG0001 affected717 at risk EG0010 affected461 at risk
Arthritis bacterial	Infections and infestations	EG0001 affected717 at risk EG0010 affected461 at risk
Lung infection	Infections and infestations	EG0001 affected717 at risk EG0010 affected461 at risk
Pneumonia staphylococcal	Infections and infestations	EG0001 affected717 at risk EG0010 affected461 at risk
Pyelonephritis acute	Infections and infestations	EG0001 affected717 at risk EG0010 affected461 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	EG0001 affected717 at risk EG0010 affected461 at risk
HIV test positive	Investigations	EG0001 affected717 at risk EG0010 affected461 at risk
Dehydration	Metabolism and nutrition disorders	EG0001 affected717 at risk EG0011 affected461 at risk
Arthritis reactive	Musculoskeletal and connective tissue disorders	EG0001 affected717 at risk EG0010 affected461 at risk
Pregnancy	Pregnancy, puerperium and perinatal conditions	EG0001 affected717 at risk EG0010 affected461 at risk
Nephrolithiasis	Renal and urinary disorders	EG0001 affected717 at risk EG0010 affected461 at risk
Anemia	Blood and lymphatic system disorders	EG0000 affected717 at risk EG0012 affected461 at risk
Atrial fibrillation	Cardiac disorders	EG0000 affected717 at risk EG0011 affected461 at risk
Bundle branch block left	Cardiac disorders	EG0000 affected717 at risk EG0011 affected461 at risk
Abdominal pain	Gastrointestinal disorders	EG0000 affected717 at risk EG0012 affected461 at risk
Diarrhea	Gastrointestinal disorders	EG0000 affected717 at risk EG0013 affected461 at risk
Pyrexia	General disorders	EG0000 affected717 at risk EG0011 affected461 at risk
Appendicitis	Infections and infestations	EG0000 affected717 at risk EG0011 affected461 at risk
Gastroenteritis	Infections and infestations	EG0000 affected717 at risk EG0011 affected461 at risk
Hepatitis B	Infections and infestations	EG0000 affected717 at risk EG0011 affected461 at risk
Forearm fracture	Injury, poisoning and procedural complications	EG0000 affected717 at risk EG0011 affected461 at risk
Road traffic accident	Injury, poisoning and procedural complications	EG0000 affected717 at risk EG0012 affected461 at risk
C-reactive protein increased	Investigations	EG0000 affected717 at risk EG0011 affected461 at risk
Back pain	Musculoskeletal and connective tissue disorders	EG0000 affected717 at risk EG0011 affected461 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	EG0000 affected717 at risk EG0011 affected461 at risk
Cerebrovascular accident	Nervous system disorders	EG0000 affected717 at risk EG0011 affected461 at risk
Hemorrhagic stroke	Nervous system disorders	EG0000 affected717 at risk EG0011 affected461 at risk
Radiculopathy	Nervous system disorders	EG0000 affected717 at risk EG0011 affected461 at risk
Metrorrhagia	Reproductive system and breast disorders	EG0000 affected717 at risk EG0011 affected461 at risk
Venous thrombosis limb	Vascular disorders	EG0000 affected717 at risk EG0011 affected461 at risk

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
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

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Colitis ulcerative	Gastrointestinal disorders				EG00010 affected717 at risk EG00143 affected461 at risk
Drug ineffective	General disorders				EG00050 affected717 at risk EG00122 affected461 at risk