Trial · NCT02980666
Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support
NCT02980666, Phase 3, Completed, Shire; results first posted 2021-02-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support. Trials, record NCT02980666. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02980666
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study in Japanese Pediatric Subjects With Short Bowel Syndrome (SBS) Who Are Dependent on Parenteral Support
- NCT number
- NCT02980666
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 10 participants, actual
- Lead sponsor
- Shire
- Conditions
- Short Bowel Syndrome
- Interventions
- Teduglutide
- First posted
- 2016-12-02
- Last updated
- 2022-02-02
- Other registries' IDs
- eudract:2020-005791-35
- Results first posted
- 2021-02-10
Source ClinicalTrials.gov
Registered outcomes44
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Absolute Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data | Baseline, EOT (up to Week 24) | Absolute change from baseline in PS volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Here, milliliter per kilogram per day is abbreviated as mL/kg/day. |
| Primary | Percent Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data | Baseline, EOT (up to Week 24) | Percent change from baseline in PS volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. |
| Primary | Absolute Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Baseline, EOT (up to Week 24) | Absolute change from baseline in PS caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. Here, kilo-calories per kilogram per day was abbreviated as (kcal/kg/day). |
| Primary | Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Baseline, EOT (up to Week 24) | Percent change from baseline in PS caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. |
| Primary | Absolute Change From Baseline in Plasma Citrulline at End of Treatment (EOT) | Baseline, EOT (up to Week 24) | Absolute change from baseline in plasma citrulline at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. |
| Primary | Percent Change From Baseline in Plasma Citrulline at End of Treatment (EOT) | Baseline, EOT (up to Week 24) | Percent change from baseline in plasma citrulline at EOT (up to Week 24) was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. |
| Primary | Absolute Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy Data | Baseline, EOT (up to Week 24) | Absolute change from baseline in EN volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. |
| Primary | Percent Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy Data | Baseline, EOT (up to Week 24) | Percent change from baseline in EN volume at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. |
| Primary | Absolute Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Baseline, EOT (up to Week 24) | Absolute change from baseline in EN caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. |
| Primary | Percent Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Baseline, EOT (up to Week 24) | Percent change from baseline in EN caloric intake at EOT (up to Week 24) based on dairy data was reported. EOT was defined as the last available measurement after the date of first dose during the 24-week treatment period. |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 registered outcomesOutcomes44
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Absolute Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data | Baseline, EOT (up to Week 24) | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for the study. | mL/kg/day | MEAN |
| PRIMARY | Percent Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data | Baseline, EOT (up to Week 24) | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for the study. | Percent Change | MEAN |
| PRIMARY | Absolute Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Baseline, EOT (up to Week 24) | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for the study. | kcal/kg/day | MEAN |
| PRIMARY | Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Baseline, EOT (up to Week 24) | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. | Percent change | MEAN |
| PRIMARY | Absolute Change From Baseline in Plasma Citrulline at End of Treatment (EOT) | Baseline, EOT (up to Week 24) | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Data for this outcome measure was not planned to be collected and analyzed for infants. | Micromoles per liter (mcmol/L) | MEAN |
| PRIMARY | Percent Change From Baseline in Plasma Citrulline at End of Treatment (EOT) | Baseline, EOT (up to Week 24) | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Data for this outcome measure was not planned to be collected and analyzed for infants. | Percent change | MEAN |
| PRIMARY | Absolute Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy Data | Baseline, EOT (up to Week 24) | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. | mL/kg/day | MEAN |
| PRIMARY | Percent Change From Baseline in Enteral Nutritional (EN) Volume at End of Treatment (EOT) Based on Dairy Data | Baseline, EOT (up to Week 24) | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure. | Percent change | MEAN |
| PRIMARY | Absolute Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Baseline, EOT (up to Week 24) | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. | kcal/kg/day | MEAN |
| PRIMARY | Percent Change From Baseline in Enteral Nutritional (EN) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Baseline, EOT (up to Week 24) | ITT population consisted of all participants who were enrolled into the study and met all eligible criteria for this study. Here, the number of participants analyzed refer to the participants evaluable for this outcome measure. | Percent change | MEAN |
1 to 10 of 44Source ClinicalTrials.gov
See all 44 outcomesResults by group68
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Absolute Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data | Total Children (Aged: 1 to 15 Years) | -11.8 | Standard Deviation 8.47 | mL/kg/day | |
| Absolute Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data | Infants (Corrected Gestational Age: 4 to < 12 Months) | -26.2 | Standard Deviation 13.61 | mL/kg/day | |
| Percent Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data | Total Children (Aged: 1 to 15 Years) | -27.7 | Standard Deviation 31.79 | Percent Change | |
| Percent Change From Baseline in Parenteral Support (PS) Volume at End of Treatment (EOT) Based on Dairy Data | Infants (Corrected Gestational Age: 4 to < 12 Months) | -26.7 | Standard Deviation 15.14 | Percent Change | |
| Absolute Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Total Children (Aged: 1 to 15 Years) | -7.2 | Standard Deviation 8.70 | kcal/kg/day | |
| Absolute Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Infants (Corrected Gestational Age: 4 to < 12 Months) | -13.8 | Standard Deviation 3.17 | kcal/kg/day | |
| Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Total Children (Aged: 1 to 15 Years) | -26.2 | Standard Deviation 33.00 | Percent change | |
| Percent Change From Baseline in Parenteral Support (PS) Caloric Intake at End of Treatment (EOT) Based on Dairy Data | Infants (Corrected Gestational Age: 4 to < 12 Months) | -25.7 | Standard Deviation 2.73 | Percent change | |
| Absolute Change From Baseline in Plasma Citrulline at End of Treatment (EOT) | Total Children (Aged: 1 to 15 Years) | 3.2 | Standard Deviation 4.28 | Micromoles per liter (mcmol/L) | |
| Percent Change From Baseline in Plasma Citrulline at End of Treatment (EOT) | Total Children (Aged: 1 to 15 Years) | 39.2 | Standard Deviation 39.46 | Percent change |
1 to 10 of 68Source ClinicalTrials.gov
See all 68 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Total Children (Aged: 1 to 15 Years) | 8 | |
| Overall Study | STARTED | Infants (Corrected Gestational Age: 4 to < 12 Months) | 2 | |
| Overall Study | COMPLETED | Total Children (Aged: 1 to 15 Years) | 8 | |
| Overall Study | COMPLETED | Infants (Corrected Gestational Age: 4 to < 12 Months) | 2 | |
| Overall Study | NOT COMPLETED | Total Children (Aged: 1 to 15 Years) | 0 | |
| Overall Study | NOT COMPLETED | Infants (Corrected Gestational Age: 4 to < 12 Months) | 0 |
Source ClinicalTrials.gov
Adverse events112
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 | Total Children (Aged: 1 - 15 Years) | 1 | 8 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Infants (Corrected Gestational Age: 4 to < 12 Months) | 0 | 2 | 0 |
| other | Abdominal pain | Gastrointestinal disorders | Total Children (Aged: 1 - 15 Years) | 1 | 8 | 1 |
| other | Abdominal pain | Gastrointestinal disorders | Infants (Corrected Gestational Age: 4 to < 12 Months) | 0 | 2 | 0 |
| other | Constipation | Gastrointestinal disorders | Total Children (Aged: 1 - 15 Years) | 2 | 8 | 2 |
| other | Constipation | Gastrointestinal disorders | Infants (Corrected Gestational Age: 4 to < 12 Months) | 0 | 2 | 0 |
| other | Dental caries | Gastrointestinal disorders | Total Children (Aged: 1 - 15 Years) | 1 | 8 | 1 |
| other | Dental caries | Gastrointestinal disorders | Infants (Corrected Gestational Age: 4 to < 12 Months) | 0 | 2 | 0 |
| other | Enteritis | Gastrointestinal disorders | Total Children (Aged: 1 - 15 Years) | 1 | 8 | 1 |
| other | Enteritis | Gastrointestinal disorders | Infants (Corrected Gestational Age: 4 to < 12 Months) | 0 | 2 | 0 |
1 to 10 of 112Source ClinicalTrials.gov
See all 112 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Total Children (Aged: 1 - 15 Years) | 0 | 8 |
| Total, all-cause mortality | Infants (Corrected Gestational Age: 4 to < 12 Months) | 0 | 2 |
| Total, other adverse events | Total Children (Aged: 1 - 15 Years) | 8 | 8 |
| Total, other adverse events | Infants (Corrected Gestational Age: 4 to < 12 Months) | 1 | 2 |
| Total, serious adverse events | Total Children (Aged: 1 - 15 Years) | 6 | 8 |
| Total, serious adverse events | Infants (Corrected Gestational Age: 4 to < 12 Months) | 2 | 2 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 37364133 | DERIVED |
Source PubMed
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 comparisons11
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
Total Children (Aged: 1 to 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): Number of Participants With Clinically Significant Changes in Vital Signs Reported as Treatment Emergent Adverse Events (TEAEs) | Trial comparisons |
Total Children (Aged: 1 to 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): Number of Participants With Clinically Significant Laboratory Abnormalities Reported as Treatment Emergent Adverse Events (TEAEs) | Trial comparisons |
| Total Children (Aged: 1 to 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Trial comparisons |
Total Children (Aged: 1 to 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): Number of Participants Who Achieved Greater Than or Equal to (>=) 20 Percent (%) Reduction in Parenteral Support (PS) Volume at Week 28 | Trial comparisons |
Total Children (Aged: 1 to 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): Number of Participants Who Achieved 100 Percent (%) Reduction in Complete Weaning of Parenteral Support (PS) Volume at End of Treatment (EOT) | Trial comparisons |
Total Children (Aged: 1 to 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): Number of Participants Who Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at End of Treatment (EOT) | Trial comparisons |
| Total Children (Aged: 1 - 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): deaths from any cause | Trial comparisons |
Total Children (Aged: 1 to 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): Number of Participants Who Achieved At Least 20 Percent (%) Reduction in Parenteral Support (PS) Volume at Week 24 | Trial comparisons |
| Total Children (Aged: 1 to 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): Number of Participants With Positive Specific Antibodies to Teduglutide | Trial comparisons |
Total Children (Aged: 1 to 15 Years) vs Infants (Corrected Gestational Age: 4 to < 12 Months): Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Reported as Treatment Emergent Adverse Events (TEAEs) | Trial comparisons |
1 to 10 of 11
See all 11 trial comparisonsTests0
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/NCT02980666
GET https://conductscience.org/api/trials/v1/NCT02980666/registered?page=2