Trial · NCT03663582
Study of Teduglutide in Japanese Participants With Short Bowel Syndrome
NCT03663582, Phase 3, Completed, Shire; results first posted 2020-08-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Teduglutide in Japanese Participants With Short Bowel Syndrome. Trials, record NCT03663582. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03663582
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Teduglutide in Japanese Participants With Short Bowel Syndrome
- NCT number
- NCT03663582
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 7 participants, actual
- Lead sponsor
- Shire
- Conditions
- Short Bowel Syndrome
- Interventions
- Teduglutide, Syringe, Needle, Vial Adapter for Device
- First posted
- 2018-09-10
- Last updated
- 2020-08-04
- Results first posted
- 2020-08-04
Source ClinicalTrials.gov
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | Change from baseline in weekly PS volume at EOT/ET was reported. |
| Primary | Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | Percent change from baseline in weekly PS volume at EOT/ET was reported. |
| Primary | Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 20 | Baseline, Week 20 | Percentage of participants who achieved at least 20% reduction from baseline in weekly PS volume at Week 20 was reported. |
| Primary | Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 | Baseline, Week 24 | Percentage of participants who achieved at least 20% reduction from baseline in weekly PS volume at Week 24 was reported. |
| Primary | Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | Percentage of participants who achieve at least 20% reduction from baseline in weekly PS at EOT/ET was reported. |
| Primary | Change From Baseline in Days Per Week of Parenteral Support (PS) at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | Change from baseline in days per week of PS at EOT/ET was reported. |
| Primary | Change From Baseline in Plasma Citrulline Levels at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | Plasma citrulline levels were measured as a biomarker of enterocyte mass. Change from baseline in plasma citrulline levels up to EOT/ET was reported. |
| Primary | Number of Participants Who Were Completely Weaned Off Parenteral Support (PS) at Week 24/End of Treatment (EOT) | Week 24/EOT | Number of participants who were completely weaned off PS at Week 24/EOT was reported. |
| Primary | Area Under the Plasma Concentration-Time Curve From Zero to the Last Measurable Concentration (AUC0-t) of Teduglutide | Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12 | AUC0-t of teduglutide was reported. |
| Primary | Maximum Plasma Concentration (Cmax) of Teduglutide | Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12 | Cmax of teduglutide was reported. |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 registered outcomesOutcomes29
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. | Liter per week (L/Week) | MEAN |
| PRIMARY | Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. | Percent change | MEAN |
| PRIMARY | Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 20 | Baseline, Week 20 | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. Here, number of participants analyzed refer to the number of participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 | Baseline, Week 24 | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. Here, number of participants analyzed refer to the number of participants evaluable for this outcome measure. | Percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. | Percentage of participants | NUMBER |
| PRIMARY | Change From Baseline in Days Per Week of Parenteral Support (PS) at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. | Days per Week | MEAN |
| PRIMARY | Change From Baseline in Plasma Citrulline Levels at End of Treatment/Early Termination (EOT/ET) | Baseline, EOT/ET (up to Week 28) | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. | Micromoles (mcmol) | MEAN |
| PRIMARY | Number of Participants Who Were Completely Weaned Off Parenteral Support (PS) at Week 24/End of Treatment (EOT) | Week 24/EOT | ITT population included all participants who were deemed eligible for teduglutide treatment at the baseline visit. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Area Under the Plasma Concentration-Time Curve From Zero to the Last Measurable Concentration (AUC0-t) of Teduglutide | Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12 | Pharmacokinetic (PK) population included all participants who received at least 1 dose of teduglutide and had at least 1 evaluable post-dose pharmacokinetic concentration value. | Hour*nanogram per milliliter (h*ng/mL) | MEAN |
| PRIMARY | Maximum Plasma Concentration (Cmax) of Teduglutide | Pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10 and 12 hours Post-dose on Day 1; Pre-dose, 1, 2 hours Post-dose on Week 4 or Week 12 | PK population included all participants who received at least 1 dose of teduglutide and had at least 1 evaluable post-dose pharmacokinetic concentration value. | Nanograms per milliliter (ng/mL) | MEAN |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 outcomesResults by group31
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) | Teduglutide | -2.92 | Standard Deviation 3.463 | Liter per week (L/Week) | |
| Percent Change From Baseline in Weekly Parenteral Support (PS) Volume at End of Treatment/Early Termination (EOT/ET) | Teduglutide | -22.19 | Standard Deviation 24.953 | Percent change | |
| Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 20 | Teduglutide | 66.7 | Percentage of participants | ||
| Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) Volume at Week 24 | Teduglutide | 66.7 | Percentage of participants | ||
| Percentage of Participants Who Achieved at Least 20 Percent (%) Reduction From Baseline in Weekly Parenteral Support (PS) at End of Treatment/Early Termination (EOT/ET) | Teduglutide | 57.1 | Percentage of participants | ||
| Change From Baseline in Days Per Week of Parenteral Support (PS) at End of Treatment/Early Termination (EOT/ET) | Teduglutide | -0.43 | Standard Deviation 1.134 | Days per Week | |
| Change From Baseline in Plasma Citrulline Levels at End of Treatment/Early Termination (EOT/ET) | Teduglutide | 11.973 | Standard Deviation 11.7309 | Micromoles (mcmol) | |
| Number of Participants Who Were Completely Weaned Off Parenteral Support (PS) at Week 24/End of Treatment (EOT) | Teduglutide | Weaned Off Parenteral Support: No | 7 | Participants | |
| Number of Participants Who Were Completely Weaned Off Parenteral Support (PS) at Week 24/End of Treatment (EOT) | Teduglutide | Weaned Off Parenteral Support: Yes | 0 | Participants | |
| Area Under the Plasma Concentration-Time Curve From Zero to the Last Measurable Concentration (AUC0-t) of Teduglutide | Teduglutide | 240.3 | Standard Deviation 80.651 | Hour*nanogram per milliliter (h*ng/mL) |
1 to 10 of 31Source ClinicalTrials.gov
See all 31 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Teduglutide | 7 | |
| Overall Study | COMPLETED | Teduglutide | 6 | |
| Overall Study | NOT COMPLETED | Teduglutide | 1 |
Source ClinicalTrials.gov
Adverse events29
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 | Anaemia | Blood and lymphatic system disorders | Teduglutide | 1 | 7 | 1 |
| other | Polycythaemia | Blood and lymphatic system disorders | Teduglutide | 1 | 7 | 1 |
| other | Back pain | Musculoskeletal and connective tissue disorders | Teduglutide | 1 | 7 | 1 |
| other | Phlebitis | Vascular disorders | Teduglutide | 1 | 7 | 1 |
| other | Abdominal distension | Gastrointestinal disorders | Teduglutide | 2 | 7 | 2 |
| other | Abdominal pain | Gastrointestinal disorders | Teduglutide | 1 | 7 | 1 |
| other | Abdominal pain lower | Gastrointestinal disorders | Teduglutide | 1 | 7 | 1 |
| other | Gastrooesophageal reflux disease | Gastrointestinal disorders | Teduglutide | 1 | 7 | 1 |
| other | Nausea | Gastrointestinal disorders | Teduglutide | 1 | 7 | 1 |
| other | Injection site reaction | General disorders | Teduglutide | 2 | 7 | 2 |
1 to 10 of 29Source ClinicalTrials.gov
See all 29 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Teduglutide | 0 | 7 |
| Total, other adverse events | Teduglutide | 7 | 7 |
| Total, serious adverse events | Teduglutide | 3 | 7 |
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/NCT03663582
GET https://conductscience.org/api/trials/v1/NCT03663582/registered?page=2