Trial · NCT00351377
Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate
NCT00351377, Phase 3, Completed, Novartis Pharmaceuticals; results first posted 2011-01-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate. Trials, record NCT00351377. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00351377
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Gastrointestinal and Health-related Quality of Life Outcomes in Patients With Autoimmune Diseases Treated With Mycophenolate
- NCT number
- NCT00351377
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 111 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Autoimmune Disease
- Interventions
- Enteric-coated Mycophenolate Sodium
- First posted
- 2006-07-12
- Last updated
- 2011-04-21
- Results first posted
- 2011-01-12
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in GI Symptom Severity After Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) | 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. |
| Secondary | Changes in the GI Symptom Severity Subscales After Conversion to Enteric-coated Mycophenolate Sodium | 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). |
| Secondary | Changes in GI-related Quality of Life Index (GIQLI), After Patients Are Converted From MMF to Enteric-coated Mycophenolate Sodium | 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). |
| Secondary | Changes in the GI-related Quality of Life Subscales After Conversion to Enteric-coated Mycophenolate Sodium | 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. |
| Secondary | Changes in Psychological General Well-Being Index (PGWB) After Conversion to Enteric-coated Mycophenolate Sodium | 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. |
| Secondary | Changes in Psychological General Well-Being Index (PGWB) Subscales After Conversion to Enteric-coated Mycophenolate Sodium | 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. |
| Secondary | Overall Treatment Effects for GI Symptoms Assessed by the Physician | 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. |
| Secondary | Overall Treatment Effects for GI Symptoms Assessed by the Patient | 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. |
| Secondary | Overall Treatment Effects for for Health-related Quality of Life Assessed by the Patient | 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. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Changes in GI Symptom Severity After Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) | Baseline and 6 - 8 weeks | Intention to treat (ITT) population consisting of all enrolled participants who received study medication. | Scores on a scale | MEAN |
| SECONDARY | Changes in the GI Symptom Severity Subscales After Conversion to Enteric-coated Mycophenolate Sodium | Baseline and 6-8 weeks | Intention to treat (ITT) population consisting of all enrolled participants who received study medication. | Scores on a scale | MEAN |
| SECONDARY | Changes in GI-related Quality of Life Index (GIQLI), After Patients Are Converted From MMF to Enteric-coated Mycophenolate Sodium | Baseline and 6-8 weeks | Intention to treat (ITT) population consisting of all enrolled participants who received study medication. | Scores on a scale | MEAN |
| SECONDARY | Changes in the GI-related Quality of Life Subscales After Conversion to Enteric-coated Mycophenolate Sodium | Baseline and 6-8 weeks | Intention to treat (ITT) population consisting of all enrolled participants who received study medication. | Scores on a scale | MEAN |
| SECONDARY | Changes in Psychological General Well-Being Index (PGWB) After Conversion to Enteric-coated Mycophenolate Sodium | Baseline and 6-8 weeks | Intention to treat (ITT) population consisting of all enrolled participants who received study medication. | Scores on a scale | MEAN |
| SECONDARY | Changes in Psychological General Well-Being Index (PGWB) Subscales After Conversion to Enteric-coated Mycophenolate Sodium | Baseline and 6-8 weeks | Intention to treat (ITT) population consisting of all enrolled participants who received study medication. | Scores on a scale | MEAN |
| SECONDARY | Overall Treatment Effects for GI Symptoms Assessed by the Physician | 6-8 week | Intention to treat population consisting of all enrolled participants who received study medication. | Participants | NUMBER |
| SECONDARY | Overall Treatment Effects for GI Symptoms Assessed by the Patient | 6-8 week | Intention to treat population consisting of all enrolled participants who received study medication. | Participants | NUMBER |
| SECONDARY | Overall Treatment Effects for for Health-related Quality of Life Assessed by the Patient | 6-8 week | Intention to treat population consisting of all enrolled participants who received study medication. | Participants | NUMBER |
Source ClinicalTrials.gov
Results by group37
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Changes in GI Symptom Severity After Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) | Enteric-coated Mycophenolate Sodium | Baseline (N= 111) | 2.28 | Standard Deviation 1.13 | Scores on a scale |
| Changes in GI Symptom Severity After Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) | Enteric-coated Mycophenolate Sodium | 6-8 Weeks (N= 102) | 2.02 | Standard Deviation 0.93 | Scores on a scale |
| Changes in GI Symptom Severity After Conversion From Mycophenolate Mofetil (MMF) to Enteric-coated Mycophenolate Sodium (EC-MPS) | Enteric-coated Mycophenolate Sodium | Change From Baseline (N = 102) | -0.28 | Standard Deviation 0.92 | Scores on a scale |
| Changes in the GI Symptom Severity Subscales After Conversion to Enteric-coated Mycophenolate Sodium | Enteric-coated Mycophenolate Sodium | Reflux [n =102] | -0.24 | Standard Deviation 1.36 | Scores on a scale |
| Changes in the GI Symptom Severity Subscales After Conversion to Enteric-coated Mycophenolate Sodium | Enteric-coated Mycophenolate Sodium | Diarrhea [n =104] | -0.27 | Standard Deviation 1.43 | Scores on a scale |
| Changes in the GI Symptom Severity Subscales After Conversion to Enteric-coated Mycophenolate Sodium | Enteric-coated Mycophenolate Sodium | Constipation [n = 104] | 0.02 | Standard Deviation 1.18 | Scores on a scale |
| Changes in the GI Symptom Severity Subscales After Conversion to Enteric-coated Mycophenolate Sodium | Enteric-coated Mycophenolate Sodium | Abdominal pain [n =102] | -0.51 | Standard Deviation 1.20 | Scores on a scale |
| Changes in the GI Symptom Severity Subscales After Conversion to Enteric-coated Mycophenolate Sodium | Enteric-coated Mycophenolate Sodium | Indigestion [n = 104] | -0.42 | Standard Deviation 1.33 | Scores on a scale |
| Changes in GI-related Quality of Life Index (GIQLI), After Patients Are Converted From MMF to Enteric-coated Mycophenolate Sodium | Enteric-coated Mycophenolate Sodium | Baseline (N= 111) | 100.2 | Standard Deviation 23.8 | Scores on a scale |
| Changes in GI-related Quality of Life Index (GIQLI), After Patients Are Converted From MMF to Enteric-coated Mycophenolate Sodium | Enteric-coated Mycophenolate Sodium | 6-8 Weeks (N= 104) | 105.6 | Standard Deviation 22.9 | Scores on a scale |
1 to 10 of 37Source ClinicalTrials.gov
See all 37 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Enteric-coated Mycophenolate Sodium | 111 | |
| Overall Study | COMPLETED | Enteric-coated Mycophenolate Sodium | 104 | |
| Overall Study | NOT COMPLETED | Enteric-coated Mycophenolate Sodium | 7 |
Source ClinicalTrials.gov
Adverse events19
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Abdominal distension | Gastrointestinal disorders | Enteric-coated Mycophenolate Sodium | 8 | 111 | |
| other | Diarrhoea | Gastrointestinal disorders | Enteric-coated Mycophenolate Sodium | 16 | 111 | |
| other | Dyspepsia | Gastrointestinal disorders | Enteric-coated Mycophenolate Sodium | 8 | 111 | |
| other | Nausea | Gastrointestinal disorders | Enteric-coated Mycophenolate Sodium | 13 | 111 | |
| other | Vomiting | Gastrointestinal disorders | Enteric-coated Mycophenolate Sodium | 10 | 111 | |
| other | Nasopharyngitis | Infections and infestations | Enteric-coated Mycophenolate Sodium | 10 | 111 | |
| serious | Nephrogenic anaemia | Blood and lymphatic system disorders | Enteric-coated Mycophenolate Sodium | 1 | 111 | |
| serious | Thrombocytopenia | Blood and lymphatic system disorders | Enteric-coated Mycophenolate Sodium | 1 | 111 | |
| serious | Diverticulum | Gastrointestinal disorders | Enteric-coated Mycophenolate Sodium | 1 | 111 | |
| serious | Bronchitis | Infections and infestations | Enteric-coated Mycophenolate Sodium | 1 | 111 |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Enteric-coated Mycophenolate Sodium | ||
| Total, other adverse events | Enteric-coated Mycophenolate Sodium | 38 | 111 |
| Total, serious adverse events | Enteric-coated Mycophenolate Sodium | 6 | 111 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00351377
GET https://conductscience.org/api/trials/v1/NCT00351377/results?page=2