Trial · NCT05023382
A Study of Teduglutide in Japanese People With Short Bowel Syndrome
NCT05023382, Completed, Takeda
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study of Teduglutide in Japanese People With Short Bowel Syndrome. Trials, record NCT05023382. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05023382
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Teduglutide in Japanese People With Short Bowel Syndrome
- NCT number
- NCT05023382
- Status
- Completed
- Enrollment
- 250 participants, actual
- Lead sponsor
- Takeda
- Conditions
- Short Bowel Syndrome
- Interventions
- Teduglutide
- First posted
- 2021-08-26
- Last updated
- 2026-08-07
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants with Adverse Events | Up to 36 months | An adverse event (AE) is any untoward or undesirable medical occurrence in a participant linked in time with the use of a pharmaceutical/ medicinal product. They are not limited to the events with clear causal relationship with treatment with concerned drug. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. |
| Primary | Number of Participants with Serious Adverse Events | Up to 36 months | A serious AE is any untoward medical occurrence or effect that at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability /incapacity, is a congenital anomaly / birth defect or is medically important due to other reasons than the above mentioned criteria. |
| Secondary | Changes from Baseline in Prescription Volume of Parenteral Nutrition Intravenous (PN/IV) Support | Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation | Changes from baseline in prescription volume of PN/IV support prescribed by investigators to 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation will be reported. |
| Secondary | Percent Change from Baseline in Prescription Volume of PN/IV Support | Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation | Percent change from baseline in prescription volume of PN/IV support to multiple timepoints (6, 12, 18, 24, 30, and 36 months) after teduglutide treatment initiation will be reported. Percent change from baseline will be calculated as following; \[prescription volume at each timepoint - prescription volume at baseline\] / prescription volume at baseline \* 100 (percent). |
| Secondary | Changes from Baseline in Dose of PN/IV Support | Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation | Changes from baseline in actual dose of PN/IV support to 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation will be reported. |
| Secondary | Percent Change from Baseline of Dose in PN/IV Support | Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation | Percent change from baseline in actual dose of PN/IV support to multiple timepoints (6, 12, 18, 24, 30, and 36 months) after teduglutide treatment initiation will be reported. Percent change from baseline will be calculated as following; \[actual dose at each timepoint - actual dose at baseline\] / actual dose at baseline \* 100 (percent). |
| Secondary | Percentage of Participants who Completely Wean off PN/IV Support | Baseline, 6, 12, 18, 24, 30, and 36 months after teduglutide treatment initiation | Number of participants who completely wean off PN/IV support will be assessed. |
| Secondary | Crohn's Disease Activity Index (CDAI) | 36 months after teduglutide treatment initiation | CDAI score is calculated from the following 8 items: (a) Number of liquid or very soft stools; (b) Abdominal pain; (c) General wellbeing; (d) Extraintestinal complications; (e) Antidiarrhoeal drugs; (f) Abdominal mass; (g) Hematocrit; and (h) Body weight. Scores of some items in CDAI are calculated based on patient diary. Total range of score is more than 0. Higher score means more severe disease and especially severe disease was defined as a value of greater than 450. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 41324792 | 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 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/NCT05023382
GET https://conductscience.org/api/trials/v1/NCT05023382/registered