Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 92 of 1163 for:    MYCOPHENOLIC ACID

Conversion of CellCept to Myfortic: A Prospective Study in Liver Transplant Recipients

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: NCT00336895
Recruitment Status : Completed
First Posted : June 14, 2006
Results First Posted : November 7, 2016
Last Update Posted : November 7, 2016
Sponsor:
Collaborator:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Roberto Lopez, MD, University of Pittsburgh

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Immunosuppression
Intervention Drug: Myfortic
Enrollment 29
Recruitment Details  
Pre-assignment Details 30 participants were screened only 29 participants were enrolled
Arm/Group Title Liver Transplant Subjects
Hide Arm/Group Description

All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.

Myfortic: Myfortic 360mg or 720 mg BID for 90 days.

Period Title: Overall Study
Started 30
Completed 26
Not Completed 4
Reason Not Completed
diarrhea             1
nausea and upset stomach             1
Physician Decision             1
screen failed             1
Arm/Group Title Liver Transplant Subjects
Hide Arm/Group Description

All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.

Myfortic: Myfortic 360mg or 720 mg BID for 90 days.

Overall Number of Baseline Participants 29
Hide Baseline Analysis Population Description
30 potential participants were screened but only 29 enrolled.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants
52.2  (13.0)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants
Female
13
  44.8%
Male
16
  55.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants
29
Abdominal Pain- screening   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 29 participants
10.7778  (5.09399)
[1]
Measure Description:

The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort.

The scale ranges from a minimal value of 3 ( No discomfort at all) to a maximum of 21 ( Very severe discomfort)

Reflux screening   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 29 participants
5.0000  (3.67423)
[1]
Measure Description:

The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort.

The scale ranges from a minimal value of 2 ( No discomfort at all) to a maximum of 14 ( Very severe discomfort)

Indigestion screening   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 29 participants
12.6800  (7.11056)
[1]
Measure Description:

The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort.

The scale ranges from a minimal value of 4 ( No discomfort at all) to a maximum of 28 ( Very severe discomfort)

Diarrhea screening   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 29 participants
10.3200  (5.57315)
[1]
Measure Description:

The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort.

The scale ranges from a minimal value of 3 ( No discomfort at all) to a maximum of 21 ( Very severe discomfort)

Constipation screening   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 29 participants
7.2000  (4.52769)
[1]
Measure Description:

The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort.

The scale ranges from a minimal value of 3 ( No discomfort at all) to a maximum of 21 ( Very severe discomfort)

1.Primary Outcome
Title Gastrointestinal Side Effects and Quality of Life (Total Score of GSRS)
Hide Description

The gastrointestinal Symptom Rating Scale (GSRS) is a validated scale, the items range from 1= No discomfort at all to 7= Very severe discomfort.

The scale ranges from a minimal value of 15 ( No discomfort at all) to a maximum of 105 ( Very severe discomfort)

The GSRS contains 15 items, each rated on a seven- point likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items breakdown into the following five scales: abdominal ( Abdominal pain, hunger pains and nausea): reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome ( borborygmus, abdominal distention, eructation and increased flatus) and constipation syndrome (constipation, hard stools and feeling of incomplete evacuation)

Time Frame screening, 2, 6 and 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liver Transplant Subjects
Hide Arm/Group Description:

All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.

Myfortic: Myfortic 360mg or 720 mg BID for 90 days.

Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
screening 46.000  (21.17585)
2 weeks 29.0400  (9.44934)
6 weeks 26.2800  (8.79640)
12 weeks 25.3600  (8.87356)
2.Primary Outcome
Title Number of Participants With Cytomegalovirus Infection or Disease
Hide Description [Not Specified]
Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liver Transplant Subjects
Hide Arm/Group Description:

All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.

Myfortic: Myfortic 360mg or 720 mg BID for 90 days.

Overall Number of Participants Analyzed 29
Measure Type: Number
Unit of Measure: participants
0
3.Primary Outcome
Title Gastrointestinal Side Effects and Quality of Life (-Subscales of GSRS)
Hide Description

The GSRS contains 15 items, each rated on a seven- point likert scale from no discomfort to very severe discomfort. Based on a factor analysis, the 15 GSRS items breakdown into the following five scales: abdominal ( Abdominal pain, hunger pains and nausea): reflux syndrome (heartburn and acid regurgitation), diarrhea syndrome (diarrhea, loose stools and urgent need for defecation), indigestion syndrome ( borborygmus, abdominal distention, eructation and increased flatus) and constipation syndrome (constipation, hard stools and feeling of incomplete evacuation) The range of the scale for abdominal pain was 3 to 21, reflux 2 to 14, diarrhea 3 to 21, indigestion 4 to 28 and constipation 3 to 21.

Higher values represent more severe discomfort.

Time Frame 12 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Liver Transplant Subjects
Hide Arm/Group Description:

All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.

Myfortic: Myfortic 360mg or 720 mg BID for 90 days.

Overall Number of Participants Analyzed 29
Mean (Standard Deviation)
Unit of Measure: units on a scale
Abdominal Pain 10.78  (5.09)
Reflux 2.64  (1.04)
Indigestion 7.08  (3.40)
Diarrhea 5.44  (3.70)
Constipation 4.56  (1.94)
Time Frame 0-12 weeks
Adverse Event Reporting Description The protocol specified adverse events including bone marrow suppression, incidence of CMV infection and incidence of acute cellular rejection.
 
Arm/Group Title Liver Transplant Subjects
Hide Arm/Group Description

All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.

Myfortic: Myfortic 360mg or 720 mg BID for 90 days.

All-Cause Mortality
Liver Transplant Subjects
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Liver Transplant Subjects
Affected / at Risk (%)
Total   0/30 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Liver Transplant Subjects
Affected / at Risk (%)
Total   0/30 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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.
Results Point of Contact
Name/Title: Dr. Roberto Lopez-Solis
Organization: UPittsburgh
Phone: 412-647-5173
Responsible Party: Roberto Lopez, MD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00336895     History of Changes
Other Study ID Numbers: CERL080A-US27
First Submitted: June 12, 2006
First Posted: June 14, 2006
Results First Submitted: May 19, 2016
Results First Posted: November 7, 2016
Last Update Posted: November 7, 2016