Trial · NCT02954458
Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
NCT02954458, Phase 3, Completed, Shire; results first posted 2021-10-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS). Trials, record NCT02954458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02954458
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Long-term Safety and Efficacy Study of Teduglutide in Pediatric Participants With Short Bowel Syndrome (SBS)
- NCT number
- NCT02954458
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 61 participants, actual
- Lead sponsor
- Shire
- Conditions
- Short Bowel Syndrome
- Interventions
- TED, SOC, Syringe, Needle
- First posted
- 2016-11-03
- Last updated
- 2025-03-28
- Other registries' IDs
- eudract:2016-000849-30
- Results first posted
- 2021-10-13
Source ClinicalTrials.gov
Registered outcomes45
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From start of study drug administration up to follow-up (up to 46 months) | An adverse event (AE) was any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. TEAEs were defined as AEs that started or worsened on or after the date of first dose of teduglutide for participants in the TED/TED, TED/NTT, and NTT/TED treatment groups, or after the core study baseline visit for participants in the NTT/NTT group. |
| Primary | Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks) | Average total urine output was recorded over a 48-hour period of parental support (PS) stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily urine output milliliter per kilogram per day (mL/kg/day) was calculated as: Total urine output over 48 hours / 2) / body weight (kilogram \[kg\]) where total urine output was calculated as the sum of the urine output in milliliter (mL) and the urine-only diaper weights in gram (g) (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF). |
| Primary | Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide Treatment (NT) | Baseline, Last visit in NT (up to Month 39) | Average total urine output was recorded over a 48 hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. Average daily urine output mL/kg/day was calculated as: (Total urine output over 48 hours/2) / body weight (kg) where total urine output was calculated as the sum of the urine output in mL and the urine-only diaper weights in gram (1g = 1mL) for the participant collected on the output diary form of electronic case report from (eCRF). |
| Primary | Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks) | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2). |
| Primary | Change From Baseline in Average Number of Stools Per Day at Last Visit During Non-Teduglutide Treatment (NT) | Baseline, Last visit in NT (up to Month 39) | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average number of stools per day. The average number of stools per day was calculated as (sum of the daily data in a 48-hour period/2). |
| Primary | Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks) | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average total daily stool/mixed stool diaper weight (gram per kilogram per day \[g/kg/day\]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day). |
| Primary | Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at Last Visit During Non-Teduglutide Treatment (NT) | Baseline, Last visit in NT (up to Month 39) | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized by the average total daily stool/mixed stool diaper weight (gram per kilogram per day \[g/kg/day\]). The body weight was used to calculate the daily stool/mixed stool diaper weight (g/kg/day). |
| Primary | Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks) | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average ostomy output per day (mL/kg/day). |
| Primary | Change From Baseline in Average Total Ostomy Output at Last Visit During Non-Teduglutide Treatment (NT) | Baseline, Last visit in NT (up to Month 39) | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The average daily fecal output was summarized the average ostomy output per day. |
| Primary | Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks) | Fecal output was recorded over a 48-hour period of PS stability before every scheduled site visit and within 1 week of implementing any PS adjustment. The Average daily fecal output was summarized the average typical stool form score using Bristol Stool Form Scale. The average typical stool form score was calculated as (sum of the daily data in a 48-hour period / 2). Typical Stool Form based on Bristol Stool Form Scale: 1 - Separate hard lumps, hard to pass, 2 - Sausage-shaped, but lumpy, 3 - Like a sausage but with cracks on the surface, 4- Like a sausage or snake, smooth and soft, 5- Soft blobs with clear-cut edges, 6- Fluffy pieces with ragged edges, a mushy stool, 7- Watery, no solid pieces. Entirely liquid. |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 registered outcomesOutcomes45
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Treatment-emergent Adverse Events (TEAEs) | From start of study drug administration up to follow-up (up to 46 months) | The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks) | The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment. | mL/kg/day | MEAN |
| PRIMARY | Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide Treatment (NT) | Baseline, Last visit in NT (up to Month 39) | The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met. | mL/kg/day | MEAN |
| PRIMARY | Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks) | The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment. | Stools per day | MEAN |
| PRIMARY | Change From Baseline in Average Number of Stools Per Day at Last Visit During Non-Teduglutide Treatment (NT) | Baseline, Last visit in NT (up to Month 39) | The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met. | Stools per day | MEAN |
| PRIMARY | Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks) | The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment. | g/kg/day | MEAN |
| PRIMARY | Change From Baseline in Average Total Daily Stool/Mixed Stool Diaper Weight at Last Visit During Non-Teduglutide Treatment (NT) | Baseline, Last visit in NT (up to Month 39) | The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met. | g/kg/day | MEAN |
| PRIMARY | Change From Baseline in Average Total Ostomy Output at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks) | The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment. | mL/kg/day | MEAN |
| PRIMARY | Change From Baseline in Average Total Ostomy Output at Last Visit During Non-Teduglutide Treatment (NT) | Baseline, Last visit in NT (up to Month 39) | The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for all the four arms: NTT/NTT, NTT/TED, TED/NTT and TED/TED. Participants who received teduglutide treatment could enter a NT period when the teduglutide treatment criteria were not met. | mL/kg/day | MEAN |
| PRIMARY | Change From Baseline in Average Bristol Stool Form Score at EOT of Last Cycle During Teduglutide Treatment | Baseline, EOT of last cycle (up to Month 36) (Cycles 1, 2, 3, 4, and 5 = 28 weeks, and Cycle 6 = 16 weeks) | The safety population consisted all enrolled participants who provided informed consent and met all the inclusion criteria. Here, overall number of participants analyzed refer to the participants evaluable for this outcome measure. Data was collected and analyzed for NTT/TED, and TED/TED arms in Teduglutide treatment. | Scale on a Score | MEAN |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 outcomesResults by group438
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) | 6 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Non-teduglutide/Teduglutide Treatment (NTT/TED) | 3 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Teduglutide /Non-teduglutide Treatment (TED/NTT) | 1 | Participants | ||
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) | Teduglutide/Teduglutide Treatment (TED/TED) | 50 | Participants | ||
| Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment | Non-teduglutide/Teduglutide Treatment (NTT/TED) | 0.26 | Standard Deviation 1.692 | mL/kg/day | |
| Change From Baseline in Average Total Urine Output at End of Treatment (EOT) of Last Cycle During Teduglutide Treatment | Teduglutide/Teduglutide Treatment (TED/TED) | 2.51 | Standard Deviation 22.607 | mL/kg/day | |
| Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide Treatment (NT) | Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) | -0.89 | Standard Deviation 7.431 | mL/kg/day | |
| Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide Treatment (NT) | Teduglutide /Non-teduglutide Treatment (TED/NTT) | 15.01 | Standard Deviation NA | mL/kg/day | |
| Change From Baseline in Average Total Urine Output at Last Visit During Non-Teduglutide Treatment (NT) | Teduglutide/Teduglutide Treatment (TED/TED) | -6.87 | Standard Deviation 26.299 | mL/kg/day | |
| Change From Baseline in Average Number of Stools Per Day at EOT of Last Cycle During Teduglutide Treatment | Teduglutide/Teduglutide Treatment (TED/TED) | -0.47 | Standard Deviation 2.272 | Stools per day |
1 to 10 of 438Source ClinicalTrials.gov
See all 438 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) | 7 | |
| Overall Study | STARTED | Non-teduglutide/Teduglutide Treatment (NTT/TED) | 3 | |
| Overall Study | STARTED | Teduglutide /Non-teduglutide Treatment (TED/NTT) | 1 | |
| Overall Study | STARTED | Teduglutide/Teduglutide Treatment (TED/TED) | 50 | |
| Overall Study | COMPLETED | Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) | 6 | |
| Overall Study | COMPLETED | Non-teduglutide/Teduglutide Treatment (NTT/TED) | 3 | |
| Overall Study | COMPLETED | Teduglutide /Non-teduglutide Treatment (TED/NTT) | 0 | |
| Overall Study | COMPLETED | Teduglutide/Teduglutide Treatment (TED/TED) | 38 | |
| Overall Study | NOT COMPLETED | Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) | 1 | |
| Overall Study | NOT COMPLETED | Non-teduglutide/Teduglutide Treatment (NTT/TED) | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events880
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 | Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) | 0 | 7 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Non-teduglutide/Teduglutide Treatment (NTT/TED) | 1 | 3 | 1 |
| other | Anaemia | Blood and lymphatic system disorders | Teduglutide /Non-teduglutide Treatment (TED/NTT) | 0 | 1 | 0 |
| other | Anaemia | Blood and lymphatic system disorders | Teduglutide/Teduglutide Treatment (TED/TED) | 2 | 50 | 4 |
| other | Coagulopathy | Blood and lymphatic system disorders | Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) | 0 | 7 | 0 |
| other | Coagulopathy | Blood and lymphatic system disorders | Non-teduglutide/Teduglutide Treatment (NTT/TED) | 0 | 3 | 0 |
| other | Coagulopathy | Blood and lymphatic system disorders | Teduglutide /Non-teduglutide Treatment (TED/NTT) | 1 | 1 | 1 |
| other | Coagulopathy | Blood and lymphatic system disorders | Teduglutide/Teduglutide Treatment (TED/TED) | 2 | 50 | 2 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) | 0 | 7 | 0 |
| other | Lymphadenopathy | Blood and lymphatic system disorders | Non-teduglutide/Teduglutide Treatment (NTT/TED) | 0 | 3 | 0 |
1 to 10 of 880Source ClinicalTrials.gov
See all 880 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) | 0 | 7 |
| Total, all-cause mortality | Non-teduglutide/Teduglutide Treatment (NTT/TED) | 0 | 3 |
| Total, all-cause mortality | Teduglutide /Non-teduglutide Treatment (TED/NTT) | 0 | 1 |
| Total, all-cause mortality | Teduglutide/Teduglutide Treatment (TED/TED) | 2 | 50 |
| Total, other adverse events | Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) | 6 | 7 |
| Total, other adverse events | Non-teduglutide/Teduglutide Treatment (NTT/TED) | 3 | 3 |
| Total, other adverse events | Teduglutide /Non-teduglutide Treatment (TED/NTT) | 1 | 1 |
| Total, other adverse events | Teduglutide/Teduglutide Treatment (TED/TED) | 50 | 50 |
| Total, serious adverse events | Non-teduglutide/Non-teduglutide Treatment (NTT/NTT) | 4 | 7 |
| Total, serious adverse events | Non-teduglutide/Teduglutide Treatment (NTT/TED) | 2 | 3 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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/NCT02954458
GET https://conductscience.org/api/trials/v1/NCT02954458/registered?page=2