Trial · NCT02682381

Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition

NCT02682381, Phase 3, Completed, Shire; results first posted 2018-10-16

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition. Trials, record NCT02682381. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02682381

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Short Bowel Syndrome Research Study for Children Up To 17 Years of Age on Parenteral Nutrition
NCT number: NCT02682381
Status: Completed
Phases: Phase 3
Enrollment: 59 participants, actual
Lead sponsor: Shire
Conditions: Short Bowel Syndrome
Interventions: Teduglutide 0.05mg/kg, Teduglutide 0.025 mg/kg, Standard of Care
First posted: 2016-02-15
Last updated: 2021-06-09
Results first posted: 2018-10-16

Source ClinicalTrials.gov

Registered outcomes20

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants Who Achieved at Least a 20 Percent (%) Reduction in Weight-Normalized Average Daily Parenteral Nutrition Intravenous (PN/IV) Volume at Week 24	Baseline through Week 24	Reduction in weight-normalized PN/IV volume was performed using both participant diary and investigator prescribed data. Number of participants who achieved at least a 20% reduction in weight-normalized PN/IV volume between the baseline and week 24/EOT visit were reported.
Secondary	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	From start of study treatment up to 28 weeks	An adverse event (AE) was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and that did 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 for treatment groups and those that started or worsened on or after the baseline visit for standard of care group.
Secondary	Number of Participants Who Were Completely Weaned Off Parenteral Nutrition Intravenous (PN/IV) Support at Week 24	Week 24	A participant was considered to have achieved independence from PN/IV support (completely weaned off PN/IV) if the investigator prescribed no PN/IV at EOT and there was no use of PN/IV recorded in the participant diary during the week prior to EOT.
Secondary	Change From Baseline in Parenteral Nutrition Intravenous (PN/IV) Volume at Week 24	Baseline, Week 24	Change in PN/IV volume was reported based on the participant diary and the investigator prescribed data.
Secondary	Change From Baseline in Parenteral Nutrition Intravenous (PN/IV) Caloric Intake at Week 24	Baseline, Week 24	Change in PN/IV caloric intake was reported based on the participant diary and the investigator prescribed data.
Secondary	Change From Baseline in Plasma Citrulline Levels at Week 24	Baseline, Week 24	Plasma citrulline level was reported.
Secondary	Change From Baseline in Enteral Nutrition Volume at Week 24	Baseline, Week 24	Enteral nutrition was defined as specialized formula taken orally or by tube feeding, and excluded table foods and other fluids. Change in enteral nutrition volume was reported.
Secondary	Change From Baseline in Enteral Nutrition Caloric Intake at Week 24	Baseline, Week 24	Enteral nutrition was defined as specialized formula taken orally or by tube feeding, and excluded table foods and other fluids. Change in enteral nutrition caloric intake was reported.
Secondary	Change From Week 24 in Parenteral Nutrition Intravenous (PN/IV) Volume at Week 28	Week 24, Week 28	Change in PN/IV volume was reported.
Secondary	Change From Week 24 in Parenteral Nutrition Intravenous (PN/IV) Caloric Intake at Week 28	Week 24, Week 28	Change in PN/IV caloric intake was reported.

1 to 10 of 20Source ClinicalTrials.gov

See all 20 registered outcomes

Outcomes20

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants Who Achieved at Least a 20 Percent (%) Reduction in Weight-Normalized Average Daily Parenteral Nutrition Intravenous (PN/IV) Volume at Week 24	Baseline through Week 24	ITT population included all enrolled participants.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants With Treatment-emergent Adverse Events (TEAEs)	From start of study treatment up to 28 weeks	Safety analysis population included all participants who received at least 1 dose of teduglutide and had undergone at least 1 post-baseline safety assessment in teduglutide treatment group or participants who had undergone at least 1 post-baseline safety assessment in standard of care treatment group.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Number of Participants Who Were Completely Weaned Off Parenteral Nutrition Intravenous (PN/IV) Support at Week 24	Week 24	ITT population included all enrolled participants.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Parenteral Nutrition Intravenous (PN/IV) Volume at Week 24	Baseline, Week 24	ITT population included all enrolled participants.	Milliliters per kilogram per day	MEAN
SECONDARY	Change From Baseline in Parenteral Nutrition Intravenous (PN/IV) Caloric Intake at Week 24	Baseline, Week 24	ITT population included all enrolled participants.	Kilocalories per kilogram per day	MEAN
SECONDARY	Change From Baseline in Plasma Citrulline Levels at Week 24	Baseline, Week 24	ITT population with number of participants evaluable for this outcome measure.	Micromoles per liter	MEAN
SECONDARY	Change From Baseline in Enteral Nutrition Volume at Week 24	Baseline, Week 24	ITT population included all enrolled participants.	Milliliter per kilogram per day	MEAN
SECONDARY	Change From Baseline in Enteral Nutrition Caloric Intake at Week 24	Baseline, Week 24	ITT population included all enrolled participants.	Kilocalorie per kilogram per day	MEAN
SECONDARY	Change From Week 24 in Parenteral Nutrition Intravenous (PN/IV) Volume at Week 28	Week 24, Week 28	ITT population included all enrolled participants.	Milliliter per kilogram per day	MEAN
SECONDARY	Change From Week 24 in Parenteral Nutrition Intravenous (PN/IV) Caloric Intake at Week 28	Week 24, Week 28	ITT population included all enrolled participants.	Kilocalorie per kilogram per day	MEAN

1 to 10 of 20Source ClinicalTrials.gov

See all 20 outcomes

Results by group91

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Units
Number of Participants Who Achieved at Least a 20 Percent (%) Reduction in Weight-Normalized Average Daily Parenteral Nutrition Intravenous (PN/IV) Volume at Week 24	0.025 mg/kg/Day Teduglutide	Participant Diary	13	Participants
Number of Participants Who Achieved at Least a 20 Percent (%) Reduction in Weight-Normalized Average Daily Parenteral Nutrition Intravenous (PN/IV) Volume at Week 24	0.05 mg/kg/Day Teduglutide	Participant Diary	18	Participants
Number of Participants Who Achieved at Least a 20 Percent (%) Reduction in Weight-Normalized Average Daily Parenteral Nutrition Intravenous (PN/IV) Volume at Week 24	Standard of Care	Participant Diary	1	Participants
Number of Participants Who Achieved at Least a 20 Percent (%) Reduction in Weight-Normalized Average Daily Parenteral Nutrition Intravenous (PN/IV) Volume at Week 24	0.025 mg/kg/Day Teduglutide	Investigator Prescribed	13	Participants
Number of Participants Who Achieved at Least a 20 Percent (%) Reduction in Weight-Normalized Average Daily Parenteral Nutrition Intravenous (PN/IV) Volume at Week 24	0.05 mg/kg/Day Teduglutide	Investigator Prescribed	18	Participants
Number of Participants Who Achieved at Least a 20 Percent (%) Reduction in Weight-Normalized Average Daily Parenteral Nutrition Intravenous (PN/IV) Volume at Week 24	Standard of Care	Investigator Prescribed	2	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	0.025 mg/kg/Day Teduglutide		24	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	0.05 mg/kg/Day Teduglutide		25	Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs)	Standard of Care		9	Participants
Number of Participants Who Were Completely Weaned Off Parenteral Nutrition Intravenous (PN/IV) Support at Week 24	0.025 mg/kg/Day Teduglutide		2	Participants

1 to 10 of 91Source ClinicalTrials.gov

See all 91 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	0.025 mg/kg/Day Teduglutide	24
Overall Study	STARTED	0.05 mg/kg/Day Teduglutide	26
Overall Study	STARTED	Standard of Care	9
Overall Study	COMPLETED	0.025 mg/kg/Day Teduglutide	24
Overall Study	COMPLETED	0.05 mg/kg/Day Teduglutide	26
Overall Study	COMPLETED	Standard of Care	9
Overall Study	NOT COMPLETED	0.025 mg/kg/Day Teduglutide	0
Overall Study	NOT COMPLETED	0.05 mg/kg/Day Teduglutide	0
Overall Study	NOT COMPLETED	Standard of Care	0

Source ClinicalTrials.gov

Adverse events327

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	Lymphadenopathy	Blood and lymphatic system disorders	0.025 mg/kg/Day Teduglutide	0	24	0
other	Lymphadenopathy	Blood and lymphatic system disorders	0.05 mg/kg/Day Teduglutide	1	26	1
other	Lymphadenopathy	Blood and lymphatic system disorders	Standard of Care	1	9	1
other	Muscle spasms	Musculoskeletal and connective tissue disorders	0.025 mg/kg/Day Teduglutide	1	24	1
other	Muscle spasms	Musculoskeletal and connective tissue disorders	0.05 mg/kg/Day Teduglutide	0	26	0
other	Muscle spasms	Musculoskeletal and connective tissue disorders	Standard of Care	1	9	1
other	Pain in extremity	Musculoskeletal and connective tissue disorders	0.025 mg/kg/Day Teduglutide	2	24	2
other	Pain in extremity	Musculoskeletal and connective tissue disorders	0.05 mg/kg/Day Teduglutide	0	26	0
other	Pain in extremity	Musculoskeletal and connective tissue disorders	Standard of Care	0	9	0
other	Ear pain	Ear and labyrinth disorders	0.025 mg/kg/Day Teduglutide	1	24	1

1 to 10 of 327Source ClinicalTrials.gov

See all 327 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	0.025 mg/kg/Day Teduglutide	0	24
Total, all-cause mortality	0.05 mg/kg/Day Teduglutide	0	26
Total, all-cause mortality	Standard of Care	0	9
Total, other adverse events	0.025 mg/kg/Day Teduglutide	24	24
Total, other adverse events	0.05 mg/kg/Day Teduglutide	23	26
Total, other adverse events	Standard of Care	9	9
Total, serious adverse events	0.025 mg/kg/Day Teduglutide	15	24
Total, serious adverse events	0.05 mg/kg/Day Teduglutide	20	26
Total, serious adverse events	Standard of Care	4	9

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37889619	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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.

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Read this trial from software.

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