Trial · NCT00336817
A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant Recipients
NCT00336817, Not applicable, Completed, University of Pittsburgh; results first posted 2017-03-09
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant Recipients. Trials, record NCT00336817. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00336817
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Prospective Study on the Tolerability and Efficacy of the de Novo Use of Myfortic in Liver Transplant Recipients
- NCT number
- NCT00336817
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 30 participants, actual
- Lead sponsor
- University of Pittsburgh
- Conditions
- Immunosuppression
- Interventions
- Myfortic, CellCept
- First posted
- 2006-06-14
- Last updated
- 2017-03-09
- Results first posted
- 2017-03-09
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil | screening, 2, 6 and 12 weeks | 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 break down into the following five scale: abdominal pain syndrome ( 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 distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation). The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The total GSRS range of scores is 15 to 105 with higher scores meaning the worst of symptoms. |
| Primary | GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil (Abdominal Pain Subscale) | screening, 2, 6 and 12 weeks | 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 break down into the following five scale: abdominal pain syndrome ( 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 distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation). The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The abdominal Pain subscale range is 3 to 21 with higher scores means worst symptoms |
| Primary | GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil (Reflux Subscale) | screening, 2, 6 and 12 weeks | 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 break down into the following five scale: abdominal pain syndrome ( 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 distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation). The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. Reflux subscale range is 2 to 14 with higher scores means worst symptoms |
| Primary | GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Indigestion Subscale) | screening, 2, 6 and 12 weeks | 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 break down into the following five scale: abdominal pain syndrome ( 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 distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation). The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The Indigestion subscale range is 4 to 28 with higher scores means worst symptoms |
| Primary | GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Diarrhea Subscale) | screening, 2, 6 and 12 weeks | 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 break down into the following five scale: abdominal pain syndrome ( 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 distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation). The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. The Diarrhea subscale range is 3 to 21 with higher scores means worst symptoms |
| Primary | GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Constipation Subscale) | screening, 2, 6 and 12 weeks | 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 break down into the following five scale: abdominal pain syndrome ( 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 distension, eructation and increased flatus) and constipation syndrome (constipation, hard stools, and feeling of incomplete evacuation). The GSRS is a disease-specific instrument of 15 items combined into five symptom clusters depicting Reflux, Abdominal pain, Indigestion, Diarrhea, and Constipation. The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. Constipation subscale range is 3 to 21 with higher scores means worst symptoms |
| Primary | Number of Participants With Bone Marrow Suppression | 12 weeks | Number of participants with: Thrombocytopenia (\<50,000 mm3), Leukopenia (\< 2000 mm3), absolute neutrophils count ( \<1000 mm3) or hemoglobin ( \< 7.0 g/dL) |
| Primary | Incidence of Cytomegalovirus Infection or Disease During the Study Period | 12 weeks | number of participants |
| Secondary | Drug Discontinuation Due to Side Effects | 12 weeks | Drug discontinuation due to drug side effects regarding Cellcept and Myfortic. |
| Secondary | Number of Participants With Clinically Significant Decrease in Serum Creatinine From Baseline Through Week 12 | 12 weeks | Creatinine levels |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil | screening, 2, 6 and 12 weeks | One participant in the myfortic group was ineligible | units on a scale | MEAN |
| PRIMARY | GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil (Abdominal Pain Subscale) | screening, 2, 6 and 12 weeks | units on a scale | MEAN | |
| PRIMARY | GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil (Reflux Subscale) | screening, 2, 6 and 12 weeks | units on a scale | MEAN | |
| PRIMARY | GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Indigestion Subscale) | screening, 2, 6 and 12 weeks | units on a scale | MEAN | |
| PRIMARY | GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Diarrhea Subscale) | screening, 2, 6 and 12 weeks | units on a scale | MEAN | |
| PRIMARY | GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil ( Constipation Subscale) | screening, 2, 6 and 12 weeks | units on a scale | MEAN | |
| PRIMARY | Number of Participants With Bone Marrow Suppression | 12 weeks | participants | NUMBER | |
| PRIMARY | Incidence of Cytomegalovirus Infection or Disease During the Study Period | 12 weeks | participants | NUMBER | |
| SECONDARY | Drug Discontinuation Due to Side Effects | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Clinically Significant Decrease in Serum Creatinine From Baseline Through Week 12 | 12 weeks | participants | NUMBER |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group62
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil | Myfortic Group | screening | 21.80 | Standard Deviation 4.37 | units on a scale |
| GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil | CellCept Group | screening | 23.07 | Standard Deviation 6.04 | units on a scale |
| GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil | Myfortic Group | 2 weeks | 24.90 | Standard Deviation 5.47 | units on a scale |
| GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil | CellCept Group | 2 weeks | 22.14 | Standard Deviation 5.08 | units on a scale |
| GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil | Myfortic Group | 6 weeks | 28.90 | Standard Deviation 16.10 | units on a scale |
| GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil | CellCept Group | 6 weeks | 26.07 | Standard Deviation 15.72 | units on a scale |
| GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil | Myfortic Group | 12 weeks | 21.80 | Standard Deviation 7.30 | units on a scale |
| GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil | CellCept Group | 12 weeks | 25.21 | Standard Deviation 15.95 | units on a scale |
| GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil (Abdominal Pain Subscale) | Myfortic Group | screening | 5.20 | Standard Deviation 1.81 | units on a scale |
| GI Side Effects as Assessed by Gastro Intestinal Symptoms Rating Scale (GSRS) of Enteric-coated Mycophenolate Sodium vs Mycophenolate Mofetil (Abdominal Pain Subscale) | CellCept Group | screening | 5.29 | Standard Deviation 1.63 | units on a scale |
1 to 10 of 62Source ClinicalTrials.gov
See all 62 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Myfortic Group | 15 | |
| Overall Study | STARTED | CellCept Group | 15 | |
| Overall Study | COMPLETED | Myfortic Group | 14 | |
| Overall Study | COMPLETED | CellCept Group | 13 | |
| Overall Study | NOT COMPLETED | Myfortic Group | 1 | |
| Overall Study | NOT COMPLETED | CellCept Group | 2 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Myfortic Group | ||
| Total, all-cause mortality | CellCept Group | ||
| Total, other adverse events | Myfortic Group | 0 | 15 |
| Total, other adverse events | CellCept Group | 0 | 15 |
| Total, serious adverse events | Myfortic Group | 0 | 15 |
| Total, serious adverse events | CellCept Group | 0 | 15 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Myfortic Group vs CellCept Group: Drug Discontinuation Due to Side Effects | Trial comparisons |
| Myfortic Group vs CellCept Group: Number of Participants With Bone Marrow Suppression | Trial comparisons |
| Myfortic Group vs CellCept Group: Number of Participants With Neurotoxicity | Trial comparisons |
| Myfortic Group vs CellCept Group: Incidence of Biopsy-proven Acute Cellular Rejection During the Study Period | Trial comparisons |
| Myfortic Group vs CellCept Group: Incidence of Cytomegalovirus Infection or Disease During the Study Period | Trial comparisons |
| Myfortic Group vs CellCept Group: Incidence of Graft Loss or Death During the Study Period | Trial comparisons |
| Myfortic Group vs CellCept Group: Number of Participants With Clinically Significant Decrease in Serum Creatinine From Baseline Through Week 12 | Trial comparisons |
| Myfortic Group vs CellCept Group: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00336817
GET https://conductscience.org/api/trials/v1/NCT00336817/results?page=2