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Trial record 10 of 1171 for:    MYCOPHENOLIC ACID

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00351377
Recruitment Status : Completed
First Posted : July 12, 2006
Results First Posted : January 12, 2011
Last Update Posted : April 21, 2011
Sponsor:
Information provided by:
Novartis

Tracking Information
First Submitted Date  ICMJE July 10, 2006
First Posted Date  ICMJE July 12, 2006
Results First Submitted Date  ICMJE December 14, 2010
Results First Posted Date  ICMJE January 12, 2011
Last Update Posted Date April 21, 2011
Study Start Date  ICMJE June 2006
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2011)
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 ]
Changes in GI symptom severity was measured by changes in the Gastrointestinal Symptom Rating Scale (GSRS) total score from baseline visit to the visit at 6-8 weeks. This total score was calculated as the average of the 15 single items (each ranging from 1-7 score points) and thus also had a range from 1-7 score points. Higher values indicate more unfavorable conditions.
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2006)
Changes in GI symptom severity after conversion from mycophenolate mofetil (MMF) to enteric-coated mycophenolate sodium; week 0, 6-8, 6-12 (optional follow-up visit)
Change History Complete list of historical versions of study NCT00351377 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2011)
  • Changes in the GI Symptom Severity Subscales After Conversion to Enteric-coated Mycophenolate Sodium [ Time Frame: Baseline and 6-8 weeks ]
    Changes in GI symptom severity was measured by changes in the total scores of 5 subscales (reflux, diarrhea, constipation, abdominal pain and indigestion) of the Gastrointestinal Symptom Rating Scale (GSRS) from baseline visit to the visit at 6-8 weeks. The GSRS is a 15-item instrument with a mean subscale score ranging from 1 (no discomfort) to 7 (very severe discomfort).
  • 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 ]
    Assessed by changes in the Gastrointestinal Quality of Life Index (GIQLI) from Baseline visit to the 6-8 week visit. The GIQLI is a 36-item questionnaire and consists of 5 different subscales. The total score was calculated as the sum of the 36 single items which each ranged from 0-4, leading to a hypothetical range from 0-144 score points (lower scores indicate more unfavorable conditions). The mean change was calculated as (6-8 week visit value) minus (Baseline value).
  • Changes in the GI-related Quality of Life Subscales After Conversion to Enteric-coated Mycophenolate Sodium [ Time Frame: Baseline and 6-8 weeks ]
    The 5 different subscales of the GI-related Quality of Life (GIQLI) were analyzed separately by calculating the average value of the items that were included in the respective subscore. Thus, the theoretical range for each of the subscores was the same as for the single items, i.e. 0-4 score points. An increase in the subscale score indicates an improvement in symptoms.
  • Changes in Psychological General Well-Being Index (PGWB) After Conversion to Enteric-coated Mycophenolate Sodium [ Time Frame: Baseline and 6-8 weeks ]
    The PGWB consists of 22 single items (each ranging from 0-5) with 7 dimensions (including the total score) to be calculated. Lower scores indicate more unfavorable conditions. The total raw score is calculated by summing up all of the single items and thus has a hypothetical range from 0-110 score points. This raw score is further transformed using the formula: (raw score / 110) x 100 to fit a range from 0-100.
  • Changes in Psychological General Well-Being Index (PGWB) Subscales After Conversion to Enteric-coated Mycophenolate Sodium [ Time Frame: Baseline and 6-8 weeks ]
    The change from baseline to the 6-8 week visit for each of the six subscores (each ranging from 0-5) of the PGWB were analyzed individually. Each of the subscores was transformed to fit a range from 0-100. Lower scores indicate more unfavorable conditions, so an increase in score indicates an improvement in symptoms.
  • Overall Treatment Effects for GI Symptoms Assessed by the Physician [ Time Frame: 6-8 week ]
    Assessed using the Overall Treatment Effects for GI symptoms questionnaire. The question was: "Has there been any change in the participant's GI symptoms since his/her last study visit? Please indicate if there has been any change in his/her symptoms." The possible answers were: "Improved", "about the same", or "worse. The questionnaire was completed by the physician.
  • Overall Treatment Effects for GI Symptoms Assessed by the Patient [ Time Frame: 6-8 week ]
    Assessed using the Overall Treatment Effects for GI symptoms questionnaire. The question was: "Has there been any change in the participant's GI symptoms since his/her last study visit? Please indicate if there has been any change in his/her symptoms." The possible answers were: "Improved", "about the same", or "worse. The questionnaire was completed by the patient.
  • Overall Treatment Effects for for Health-related Quality of Life Assessed by the Patient [ Time Frame: 6-8 week ]
    Assessed using the Overall Treatment Effects for health-related quality of life questionnaire. Possible answers were: "Improved", "about the same", or "worse. The questionnaire was completed by the patient.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2006)
  • proportion of patients who are experiencing at least minor GI symptoms under MMF-based immunosuppressive therapy; week 0, 6-8 weeks, and 6-12 weeks (optional follow-up visit)
  • changes in health related quality of life, and impact of immunosuppressive-induced GI symptoms; week 0, 6-8 weeks, and 6-12 weeks (optional follow-up visit)
  • therapeutic efficacy; week 0, 6-8 weeks, and 6-12 weeks (optional follow-up visit)
  • identification of specific indications within the broad range of autoimmune diseases in which patients profit most from conversion to enteric-coated mycophenolate sodium; week 0, 6-8 weeks, 6-12 weeks (optional follow-up visit)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate
Official Title  ICMJE Measurement and Analysis of Patient Reported Gastrointestinal (GI) and Health-related Quality of Life (HRQL) Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate (MPA)
Brief Summary Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will 1) determine the proportion of patients with autoimmune diseases who are experiencing any GI complaints under MMF-based immunosuppressive treatment and 2) assess if a switch from MMF to enteric-coated mycophenolate sodium (EC-MPS) results in improved GI and/or health-related quality of life outcomes.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autoimmune Disease
Intervention  ICMJE Drug: Enteric-coated Mycophenolate Sodium
Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily.
Other Name: Myfortic
Study Arms  ICMJE Experimental: 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.
Intervention: Drug: Enteric-coated Mycophenolate Sodium
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 12, 2009)
111
Original Enrollment  ICMJE
 (submitted: July 10, 2006)
200
Actual Study Completion Date  ICMJE June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion criteria:

  1. Patients with autoimmune diseases;
  2. receiving immunosuppressive therapy that includes MMF at time of study enrollment;
  3. receiving immunosuppressive regimen that includes MMF at a stable dose for at least 1 month prior to enrollment. Patients can only be enrolled into the study if it is expected that treatment will continue at the same dose until study end (6-8 weeks after enrollment).

Exclusion criteria:

  1. If applicable, GI symptoms assumed or known not to be caused by Mycophenolic acid (MPA) therapy (e.g. oral biphosphonates induced, infectious diarrhea);
  2. Women of child-bearing potential who are planning to become pregnant or are pregnant and/or lactating or who are unwilling to use effective means of contraception;
  3. Presence of psychiatric illness (i.e., schizophrenia, major depression) that, in the opinion of the site investigator, would interfere with study requirements;
  4. Current acute medical intervention or hospitalization;
  5. Presence of a medical condition not related to a GI event at time of visit, which requires immediate medical intervention.

Other protocol-defined inclusion/exclusion criteria may apply

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries Switzerland
 
Administrative Information
NCT Number  ICMJE NCT00351377
Other Study ID Numbers  ICMJE CERL080ADE08
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party External Affairs, Novartis Pharmaceuticals
Study Sponsor  ICMJE Novartis Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date April 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP