Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate

This study has been completed.

Study NCT00351377 Information provided by Novartis

First Received on July 10, 2006. Last Updated on April 19, 2011 History of Changes

Results First Received: December 14, 2010

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Treatment
Condition:	Autoimmune Disease
Intervention:	Drug: Enteric-coated Mycophenolate Sodium

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Enteric-coated Mycophenolate Sodium	Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.

Participant Flow: Overall Study

	Enteric-coated Mycophenolate Sodium
STARTED	111
COMPLETED	104
NOT COMPLETED	7
Adverse Event	5
Death	1
Unsatisfactory therapeutic effect	1

Baseline Characteristics

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Reporting Groups

	Description
Enteric-coated Mycophenolate Sodium	Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.

Baseline Measures

	Enteric-coated Mycophenolate Sodium
Number of Participants [units: participants]	111
Age [units: years] Mean ± Standard Deviation	49.5 ± 14.1
Gender [units: participants]
Female	82
Male	29

Outcome Measures

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1. Primary:

Changes in GI Symptom Severity After Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) [ Time Frame: Baseline and 6 - 8 weeks ]

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2. Secondary:

Changes in the GI Symptom Severity Subscales After Conversion to Enteric-coated Mycophenolate Sodium [ Time Frame: Baseline and 6-8 weeks ]

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3. Secondary:

Changes in GI-related Quality of Life Index (GIQLI), After Patients Are Converted From MMF to Enteric-coated Mycophenolate Sodium [ Time Frame: Baseline and 6-8 weeks ]

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4. Secondary:

Changes in the GI-related Quality of Life Subscales After Conversion to Enteric-coated Mycophenolate Sodium [ Time Frame: Baseline and 6-8 weeks ]

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5. Secondary:

Changes in Psychological General Well-Being Index (PGWB) After Conversion to Enteric-coated Mycophenolate Sodium [ Time Frame: Baseline and 6-8 weeks ]

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6. Secondary:

Changes in Psychological General Well-Being Index (PGWB) Subscales After Conversion to Enteric-coated Mycophenolate Sodium [ Time Frame: Baseline and 6-8 weeks ]

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7. Secondary:

Overall Treatment Effects for GI Symptoms Assessed by the Physician [ Time Frame: 6-8 week ]

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8. Secondary:

Overall Treatment Effects for GI Symptoms Assessed by the Patient [ Time Frame: 6-8 week ]

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9. Secondary:

Overall Treatment Effects for for Health-related Quality of Life Assessed by the Patient [ Time Frame: 6-8 week ]

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Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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Results Point of Contact:

Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300

No publications provided

Responsible Party:	External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00351377 History of Changes
Other Study ID Numbers:	CERL080ADE08
Study First Received:	July 10, 2006
Results First Received:	December 14, 2010
Last Updated:	April 19, 2011
Health Authority:	Belgium: Institutional Review Board