NCT02949362 is a Phase 3 clinical trial of Teduglutide in Short Bowel Syndrome, sponsored by Shire.

Who is sponsoring NCT02949362?

NCT02949362 is sponsored by Shire.

What drugs are being tested in NCT02949362?

Interventions in NCT02949362: Teduglutide, SOC.

What condition does NCT02949362 study?

NCT02949362 studies Short Bowel Syndrome.

Is NCT02949362 still recruiting?

NCT02949362 is currently completed. Last updated 19 March 2025.

Are results published for NCT02949362?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-03-19 · How we verify

NCT02949362

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Long-term Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome Who Completed the TED-C13-003 Study

Completed Phase 3 Results posted Last updated 19 March 2025

What this trial tests

Phase 3 trial testing Teduglutide in Short Bowel Syndrome in 29 participants. Completed in 14 July 2020.

Timeline

9 December 2016

Primary endpoint
14 July 2020

14 July 2020

Quick facts

Lead sponsor	Shire
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	29
Start date	9 December 2016
Primary completion	14 July 2020
Estimated completion	14 July 2020
Sites	11 locations across United Kingdom, United States

Drugs / interventions tested

Teduglutide (TEDUGLUTIDE) — full drug profile →
SOC

Conditions studied

Short Bowel Syndrome — all drugs for Short Bowel Syndrome →

Sponsor

Shire — full company profile →

Who can join

Eligibility, any sex, with Short Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Adverse Events (AEs) in Retrospective Observation Period Primary · From end of the core study (TED-C13-003 [NCT01952080]) up to the beginning of the prospective period (up to Week 168)

An 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. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, was life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, was an important medical event. Number of particip

Participants with AEs

Group	Value	95% CI
Retrospective TED/NTT Group	23
Retrospective TED/TED Group	4

Participants with Related AEs

Group	Value	95% CI
Retrospective TED/NTT Group	23
Retrospective TED/TED Group	4

Participants with SAEs

Group	Value	95% CI
Retrospective TED/NTT Group	23
Retrospective TED/TED Group	4

Participants with Related SAE

Group	Value	95% CI
Retrospective TED/NTT Group	0
Retrospective TED/TED Group	0

Change From Baseline in Height for Age Z-score up to Week 168 of Retrospective Observation Period Primary · Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to the beginning of the prospective period (up to Week 168)

Height was measured using age Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age greater than or equal to \[\>=\] 2 years old) and World Health Organization (age less than \[\<\] 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in height for age Z-score up to Week 168 of retrospective observation

Group	Value	95% CI
Retrospective TED/NTT Group	0.128	± 0.0505

Change From Baseline in Body Weight for Age Z-score up to Week 168 of Retrospective Observation Period Primary · Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to the beginning of the prospective period (up to Week 168)

Body weight was measured using age Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in body weight for age Z-score up to Week 168 was reported. Data for this outcome was not planned to be coll

Group	Value	95% CI
Retrospective TED/NTT Group	-0.181	± 0.0601

Change From Baseline in Body Mass Index (BMI) for Age Z-score up to Week 168 of Retrospective Observation Period Primary · Baseline (Baseline visit in the core study [TED-C13-003 (NCT01952080)]) up to the beginning of the prospective period (up to Week 168)

BMI Z-score was calculated by using the retrospective height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in height for age Z-score up to Week 168 of retrospective observation peri

Group	Value	95% CI
Retrospective TED/NTT Group	-0.283	± 0.0646

Number of Participants With Treatment Emergent Adverse Events (TEAEs) of Prospective Study Period Primary · From the beginning of the prospective study period to End of Study (EOS) (up to Week 144)

TEAEs are defined as AEs that started or worsened on or after the first dose of teduglutide treatment in the core study. A SAE was any untoward medical occurrence (whether considered to be related to investigational product or not) that at any dose: results in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, was a congenital abnormality/birth defect, was an important medical event. AESI was an TEAE or TESAE of scientific and medical concern specific to the sponsor's product o

Participants with TEAEs

Group	Value	95% CI
Prospective TED/NTT Group	4
Prospective TED/TED Group	19

Participants with TESAEs

Group	Value	95% CI
Prospective TED/NTT Group	3
Prospective TED/TED Group	17

Participants with AESI

Group	Value	95% CI
Prospective TED/NTT Group	0
Prospective TED/TED Group	0

Change From Baseline in Height for Age Z-score up to Cycle 6 Week 12 During the End of Teduglutide Treatment Period of Prospective Study Period Primary · Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 12

Height was measured using age Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in height for age Z-score up to Cycle 6 Week 12 during the end of teduglutide treatment period in prospective stu

Group	Value	95% CI
Prospective TED/TED Group	0.05	± 1.068

Change From Baseline in Body Weight for Age Z-score up to Cycle 6 Week 24 During the End of Teduglutide Treatment Period of Prospective Study Period Primary · Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 24

Body weight was measured using age Z-score. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in body weight for age Z-score up to Cycle 6 Week 24 during the end of teduglutide treatment period of prosp

Group	Value	95% CI
Prospective TED/TED Group	-0.66	± NA

Change From Baseline in BMI for Age Z-score up to Cycle 6 Week 12 During the End of Teduglutide Treatment Period of Prospective Study Period Primary · Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 12

BMI Z-score was calculated by using the height and weight data. Z-score was calculated as (observed value - median value of the reference population) / standard deviation value of reference population. Centers for Disease Control and Prevention (age \>= 2 years old) and World Health Organization (age \< 2 years old) Z-score calculation charts are used for calculation. A negative Z-score indicates values lower than the mean while a positive Z-score indicates values higher than the mean. Change from baseline in BMI for age Z-score up to Cycle 6 Week 12 during the end of teduglutide treatment per

Group	Value	95% CI
Prospective TED/TED Group	-0.68	± 0.349

Average Total 48-Hour Urine Output up to Cycle 6 Week 12 During the End of Teduglutide Treatment Period of Prospective Study Period Primary · Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 12

Average total urine output was calculated based on the daily data recorded in participants diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average total 48-Hour urine output up to Cycle 6 Week 12 during the end of teduglutide treatment period of prospective study period was reported. Here, mL/kg/day is abbreviated as milliliter per kilogram per day.

Group	Value	95% CI
Prospective TED/TED Group	14.38	± 12.712

Average Total 48-Hour Urine Output up to Week 108 During the End of Non-Teduglutide Treatment (NTT) Period of Prospective Study Period Primary · Baseline (from the beginning of the prospective study period) up to Week 108

Average total urine output was calculated based on the daily data recorded in participants diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average total 48-Hour urine output up to Week 108 during the end of NTT period in prospective study period was reported.

Group	Value	95% CI
Prospective TED/NTT Group	22.86	± 9.956

Average Number of Stools Per Day up to Cycle 6 Week 24 During the End of Teduglutide Treatment Period of Prospective Study Period Primary · Baseline (from the beginning of the prospective study period) up to Cycle 6 Week 24

Average number of stools per day was calculated based on the daily data recorded in participants diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average number of stools per day up to cycle 6 week 24 during the end of teduglutide treatment period in prospective study period was reported.

Group	Value	95% CI
Prospective TED/TED Group	5.50	± NA

Average Number of Stools Per Day up to Week 120 During the End of NTT Period of Prospective Study Period Primary · Baseline (from the beginning of the prospective study period) up to Week 120

Average number of stools per day was calculated based on the daily data recorded in participants diaries over a 48-hour period of nutritional stability prior to each scheduled visit. Average number of stools per day up to Week 120 during the end of NTT period in prospective study period was reported.

Group	Value	95% CI
Prospective TED/NTT Group	3.75	± 3.182

Adverse events — posted to ClinicalTrials.gov

Time frame: From start of screening up to end of the study (up to 168 weeks). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Retrospective TED/NTT Group

Serious: 23/24 (96%)

Deaths: 0/24

Retrospective TED/TED Group

Serious: 4/5 (80%)

Deaths: 0/5

Prospective TED/NTT Group

Serious: 3/5 (60%)

Deaths: 0/5

Prospective TED/TED Group

Serious: 17/19 (89%)

Deaths: 0/19

Serious adverse events (86 terms)

Reaction	System	Retrospective TED/NTT Group	Retrospective TED/TED Group	Prospective TED/NTT Group	Prospective TED/TED Group
Device related infection	Infections and infestations	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Device breakage	Product Issues	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Device malfunction	Product Issues	—	—	—	—
Haemorrhagic anaemia	Blood and lymphatic system disorders	—	—	—	—
Gastrointestinal haemorrhage	Gastrointestinal disorders	—	—	—	—
Ileus	Gastrointestinal disorders	—	—	—	—
Pancreatitis	Gastrointestinal disorders	—	—	—	—
Short-bowel syndrome	Gastrointestinal disorders	—	—	—	—
Vomiting	Gastrointestinal disorders	—	—	—	—
Bacteraemia	Infections and infestations	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Gastroenteritis viral	Infections and infestations	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Urosepsis	Infections and infestations	—	—	—	—
Viral infection	Infections and infestations	—	—	—	—
Dehydration	Metabolism and nutrition disorders	—	—	—	—
Electrolyte imbalance	Metabolism and nutrition disorders	—	—	—	—
Central venous catheterisation	Surgical and medical procedures	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Febrile neutropenia	Blood and lymphatic system disorders	—	—	—	—
Microcytic anaemia	Blood and lymphatic system disorders	—	—	—	—
Tachycardia	Cardiac disorders	—	—	—	—

Other adverse events (145 terms — click to expand)

Reaction	System	Retrospective TED/NTT Group	Retrospective TED/TED Group	Prospective TED/NTT Group	Prospective TED/TED Group
Vomiting	Gastrointestinal disorders	—	—	—	—
Abdominal pain	Gastrointestinal disorders	—	—	—	—
Upper respiratory tract infection	Infections and infestations	—	—	—	—
Cough	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—	—
C-reactive protein increased	Investigations	—	—	—	—
Headache	Nervous system disorders	—	—	—	—
Rash	Skin and subcutaneous tissue disorders	—	—	—	—
Anaemia	Blood and lymphatic system disorders	—	—	—	—
Abdominal distension	Gastrointestinal disorders	—	—	—	—
Nausea	Gastrointestinal disorders	—	—	—	—
Gastroenteritis	Infections and infestations	—	—	—	—
Gastroenteritis viral	Infections and infestations	—	—	—	—
Nasopharyngitis	Infections and infestations	—	—	—	—
Urinary tract infection	Infections and infestations	—	—	—	—
Viral infection	Infections and infestations	—	—	—	—
Bacterial test positive	Investigations	—	—	—	—
Dizziness	Nervous system disorders	—	—	—	—
Lethargy	Nervous system disorders	—	—	—	—
Device occlusion	Product Issues	—	—	—	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—	—	—
Dyspepsia	Gastrointestinal disorders	—	—	—	—
Faecal volume increased	Gastrointestinal disorders	—	—	—	—
Frequent bowel movements	Gastrointestinal disorders	—	—	—	—
Gastritis	Gastrointestinal disorders	—	—	—	—
Haematochezia	Gastrointestinal disorders	—	—	—	—
Lip swelling	Gastrointestinal disorders	—	—	—	—
Proctalgia	Gastrointestinal disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Pyrexia	General disorders	—	—	—	—
Ear infection	Infections and infestations	—	—	—	—
Influenza	Infections and infestations	—	—	—	—
Otitis media	Infections and infestations	—	—	—	—
Respiratory tract infection	Infections and infestations	—	—	—	—
Viral upper respiratory tract infection	Infections and infestations	—	—	—	—
White blood cells urine positive	Investigations	—	—	—	—
Decreased appetite	Metabolism and nutrition disorders	—	—	—	—
Pain in extremity	Musculoskeletal and connective tissue disorders	—	—	—	—
Dyspnoea	Respiratory, thoracic and mediastinal disorders	—	—	—	—

Most-reported serious reactions: Device related infection, Pyrexia, Device breakage, Influenza, Device malfunction, Haemorrhagic anaemia, Gastrointestinal haemorrhage, Ileus.

Data from ClinicalTrials.gov NCT02949362 adverse events section.

Sponsor's own description

The purpose of this study is to evaluate the safety and efficacy of teduglutide treatment of children with short bowel syndrome (SBS) who completed the TED-C13-003 study over a long-term period. It will evaluate how these children fared after the TED-C13-003 study ended. This study will also offer teduglutide treatment to eligible subjects, regardless of treatment received in TED-C13-003.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Safety and Efficacy of Teduglutide in Pediatric Patients With Intestinal Failure due to Short Bowel Syndrome: A 24-Week, Phase III Study.
Kocoshis SA, Merritt RJ, Hill S, Protheroe S, et al · · 2020 · cited 86× · PMID 31495952 · DOI 10.1002/jpen.1690
Safety Findings in Pediatric Patients During Long-Term Treatment With Teduglutide for Short-Bowel Syndrome-Associated Intestinal Failure: Pooled Analysis of 4 Clinical Studies.
Hill S, Carter BA, Cohran V, Horslen S, et al · · 2021 · cited 21× · PMID 33305440 · DOI 10.1002/jpen.2061
Use of Teduglutide in Children With Intestinal Failure: A Systematic Review.
Gigola F, Cianci MC, Cirocchi R, Ranucci MC, et al · · 2022 · cited 16× · PMID 35774551 · DOI 10.3389/fnut.2022.866518
Long-term teduglutide associated with improved response in pediatric short bowel syndrome-associated intestinal failure.
Wales PW, Hill S, Robinson I, Raphael BP, et al · · 2024 · cited 11× · PMID 38873891 · DOI 10.1002/jpn3.12276
Quality of life for pediatric patients with short bowel syndrome-associated intestinal failure treated with teduglutide.
Wendel D, Wales PW, Kocoshis S, Venick R, et al · · 2026 · PMID 41858082 · DOI 10.1002/jpn3.70358
Abstract
· 2025
Abstract
· 2024
Abstract
· 2024

Verify or expand the search:

Other trials of Teduglutide

Trials testing the same drug.

NCT06973304 — A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome · Phase 3 · recruiting
NCT03953170 — Pilot Study to Investigate the Effect of Teduglutide on Temporary Ileostomy Function and Complications · Phase 3 · withdrawn
NCT05027308 — A Study of Teduglutide in Japanese Children With Short Bowel Syndrome Aged 4 Months or Older · Phase 3 · completed
NCT05023382 — A Study of Teduglutide in Japanese People With Short Bowel Syndrome · active not recruiting
NCT04832087 — Pediatric Teduglutide Registry · completed

Other recruiting trials for Short Bowel Syndrome

Currently open trials in the same condition.

NCT07197944 — Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS · Phase 3 · recruiting
NCT05535361 — A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in A · NA · recruiting
NCT06973304 — A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome · Phase 3 · recruiting
NCT06326645 — Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome · EARLY_PHASE1 · recruiting
NCT06771505 — SBS DISK- Creation of a Quality of Life Tool for Short Bowel Patients Compared With a Validated Quality of Life Question · recruiting

Other Shire trials

Trials by the same sponsor.

NCT05067868 — A Study of Replagal in Children and Adults With Fabry Disease in India · Phase 4 · recruiting
NCT03878953 — A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism · Phase 3 · withdrawn
NCT04840667 — A Study of Replagal in Treatment-naïve Adults With Fabry Disease · Phase 3 · terminated
NCT04429984 — Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India · completed
NCT04440488 — ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study · Phase 4 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02949362 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shire
Last refreshed: 19 March 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02949362.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing