A Study Designed to Compare the Tolerability of an Increa... | NCT00658333

NCT00658333

Status Module

Sponsor/Collaborators Module

Oversight Module

No data available

No data is available for this block.

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
Enteric-coated Mycophenolate Acid	Experimental	Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.	Drug: Enteric-coated Mycophenolate Acid (EC-MPA) Drug: Placebo MMF
Mycophenolate Mofetil	Active Comparator	Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.	Drug: Mycophenolate Mofetil (MMF) Drug: Placebo EC-MPA

Name	Type	Description	Arm Group Labels	Other Names
Enteric-coated Mycophenolate Acid (EC-MPA)	Drug		Enteric-coated Mycophenolate Acid	myfortic®

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants With Response (Yes/no)	The primary variable was the response (yes/no) with positive response being defined as an increase of 360 mg/day enteric-coated mycophenolate acid (MPA)from the baseline daily dose, tolerated and maintained for a 4 week duration until the end of the study (Week 6). Tolerability was defined as the overall assessment of improvement or no change in the intensity of physician assessed gastrointestinal (GI) symptoms at end of study as reported on the physician administered evaluation of GI symptomatology.	6 weeks

Secondary Outcomes

Measure	Description	Time Frame
Average Daily Doses (mg) of Enteric-coated Mycophenolate Acid (MPA) and Mycophenolate Mofetil (MMF) by Treatment Duration Intervals	The average daily doses of enteric-coated mycophenolate acid (MPA) and mycophenolate mofetil (MMF) at baseline and during the last 2 weeks of treatment. 1000 mg MMF = 720 mg enteric-coated MPA (MPA equivalent dose).	Baseline and week 4 to week 6

Eligibility Module

Contacts/Locations Module

Facility	Status	City	State	ZIP	Country	Contacts
Novartis		Phoenix	Arizona	85012	United States
Novartis

References Module

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IPD Sharing Statement Module

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Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Enteric-coated Mycophenolate Acid	Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
FG001

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

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Document Section

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Derived Section

Miscellaneous Info Module

Submission Tracking

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Condition Browse Module

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No data is available for this block.

Intervention Browse Module

Masking Info

Type of Units Analyzed

Arm/Group Information

ID	Title	Description
BG000	Enteric-coated Mycophenolate Acid	Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
BG001	Mycophenolate Mofetil	Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
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

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00051.3± 12.54 BG00149.8± 12.45 BG00250.5± 12.30

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG0008 BG0017 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG00015 BG00115 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

Number of Participants With Response (Yes/no)

The primary variable was the response (yes/no) with positive response being defined as an increase of 360 mg/day enteric-coated mycophenolate acid (MPA)from the baseline daily dose, tolerated and maintained for a 4 week duration until the end of the study (Week 6). Tolerability was defined as the overall assessment of improvement or no change in the intensity of physician assessed gastrointestinal (GI) symptoms at end of study as reported on the physician administered evaluation of GI symptomatology.

Intent to Treat Population

Posted

Dec 2010

Number

Participants

6 weeks

ID	Title	Description
OG000	Enteric-coated Mycophenolate Acid	Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
OG001	Mycophenolate Mofetil	Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.

Units	Counts
Participants	OG00015 OG00115

Title

Denominators

Categories

Yes

Title	Measurements
	OG00010 OG0019

Title	Measurements
	OG000

Secondary

Average Daily Doses (mg) of Enteric-coated Mycophenolate Acid (MPA) and Mycophenolate Mofetil (MMF) by Treatment Duration Intervals

The average daily doses of enteric-coated mycophenolate acid (MPA) and mycophenolate mofetil (MMF) at baseline and during the last 2 weeks of treatment. 1000 mg MMF = 720 mg enteric-coated MPA (MPA equivalent dose).

Safety Population

Posted

Dec 2010

Mean

Standard Deviation

Baseline and week 4 to week 6

ID	Title	Description
OG000	Enteric-coated Mycophenolate Acid	Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.
OG001	Mycophenolate Mofetil	Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.

Units	Counts
Participants

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	Enteric-coated Mycophenolate Acid	Equimolar dose of enteric-coated mycophenolate acid with mycophenolate mofetil placebo. 1000 mg mycophenolate mofetil = 720 mg enteric-coated mycophenolate acid (MPA equivalent dose). The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.			2	15	12	15
EG001	Mycophenolate Mofetil	Mycophenolate mofetil therapy with placebo enteric-coated mycophenolate acid. The active and placebo study medications were dispensed in separate bottles identified as Bottle A and Bottle B.			0	15	12	15

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Blood creatinine increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Renal failure acute	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Neutropenia	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Abdominal distension	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0014 affected15 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0012 affected15 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0011 affected15 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0013 affected15 at risk
Defaecation urgency	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0004 affected15 at risk EG0014 affected15 at risk
Dyspepsia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0014 affected15 at risk
Eructation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0002 affected15 at risk EG0013 affected15 at risk
Flatulence	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected15 at risk EG0014 affected15 at risk
Gastrointestinal disorder	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0003 affected15 at risk EG0011 affected15 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0014 affected15 at risk
Haematochezia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Haemorrhoids	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Mouth ulceration	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Nausea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0011 affected15 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Chest discomfort	General disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Fatigue	General disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Oedema peripheral	General disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Seasonal allergy	Immune system disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Human polyomavirus infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Sputum purulent	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Complications of transplant surgery	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Eosinophil count increased	Investigations	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Lymphocyte count decreased	Investigations	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0011 affected15 at risk
Weight increased	Investigations	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Anorexia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Hyperuricaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Hypomagnesaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0011 affected15 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0011 affected15 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Night sweats	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk
Pruritus	Skin and subcutaneous tissue disorders	MedDRA	Systematic Assessment	EG0001 affected15 at risk EG0010 affected15 at risk
Hypertension	Vascular disorders	MedDRA	Systematic Assessment	EG0000 affected15 at risk EG0011 affected15 at risk

Due to the insufficient number of patients enrolled in the study, no conclusions can be made from the data.

Certain Agreements

ID	Term
D009173	Mycophenolic Acid

ID	Term
D002208	Caproates
D000144	Acids, Acyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals
D005227	Fatty Acids
D008055	Lipids