Trial · NCT00930644

Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

NCT00930644, Phase 3, Completed, Shire; results first posted 2014-12-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS). Trials, record NCT00930644. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00930644

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Trial

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

Title: Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)
NCT number: NCT00930644
Status: Completed
Phases: Phase 3
Enrollment: 88 participants, actual
Lead sponsor: Shire
Conditions: Short Bowel Syndrome
Interventions: teduglutide
First posted: 2009-06-30
Last updated: 2021-06-11
Other registries' IDs: eudract:2009-011679-65
Results first posted: 2014-12-24

Source ClinicalTrials.gov

Registered outcomes3

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

List	Outcome	Time frame	Description
Primary	Percent Change in PN/IV Volume by Visit	24 months	The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.
Primary	Absolute Change in PN/IV Volume by Visit	24 months	The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.
Secondary	Number of Subjects Achieving PN/IV Reduction	24 Months or Last Dosing Visit	The number of subjects who achieve at least 1-, 2-, and 3-day reductions in PN/IV per Week.

Source ClinicalTrials.gov

Outcomes3

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

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Percent Change in PN/IV Volume by Visit	24 months	percent change	MEAN
PRIMARY	Absolute Change in PN/IV Volume by Visit	24 months	Liters	MEAN
SECONDARY	Number of Subjects Achieving PN/IV Reduction	24 Months or Last Dosing Visit	participants	NUMBER

Source ClinicalTrials.gov

Results by group69

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

Outcome	Group	Category	Value	Spread	Units
Percent Change in PN/IV Volume by Visit	NT/TED	Month 1	-5.35	Standard Deviation 11.287	percent change
Percent Change in PN/IV Volume by Visit	PBO/TED	Month 1	-6.44	Standard Deviation 11.241	percent change
Percent Change in PN/IV Volume by Visit	TED/TED	Month 1	-40.65	Standard Deviation 21.546	percent change
Percent Change in PN/IV Volume by Visit	NT/TED	Month 2	-12.88	Standard Deviation 22.789	percent change
Percent Change in PN/IV Volume by Visit	PBO/TED	Month 2	-10.27	Standard Deviation 14.027	percent change
Percent Change in PN/IV Volume by Visit	TED/TED	Month 2	-44.24	Standard Deviation 21.823	percent change
Percent Change in PN/IV Volume by Visit	NT/TED	Month 3	-10.83	Standard Deviation 47.396	percent change
Percent Change in PN/IV Volume by Visit	PBO/TED	Month 3	-14.18	Standard Deviation 16.440	percent change
Percent Change in PN/IV Volume by Visit	TED/TED	Month 3	-45.80	Standard Deviation 22.681	percent change
Percent Change in PN/IV Volume by Visit	NT/TED	Month 6	-24.13	Standard Deviation 17.496	percent change

1 to 10 of 69Source ClinicalTrials.gov

See all 69 results by group

Participant flow3

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Teduglutide 0.05 mg/kg/Day	88
Overall Study	COMPLETED	Teduglutide 0.05 mg/kg/Day	65
Overall Study	NOT COMPLETED	Teduglutide 0.05 mg/kg/Day	23

Source ClinicalTrials.gov

Adverse events190

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	Blood and Lymphatic System Disorders	Blood and lymphatic system disorders	NT,PBO/TED	5	51	10
other	Blood and Lymphatic System Disorders	Blood and lymphatic system disorders	TED/TED	3	37	5
other	Gastrointestinal Disorders	Gastrointestinal disorders	NT,PBO/TED	34	51	148
other	Gastrointestinal Disorders	Gastrointestinal disorders	TED/TED	20	37	68
other	General Disorders, and Administration Site Conditions	General disorders	NT,PBO/TED	27	51	100
other	General Disorders, and Administration Site Conditions	General disorders	TED/TED	15	37	40
other	Hepatobiliary Disorders	Hepatobiliary disorders	NT,PBO/TED	8	51	10
other	Hepatobiliary Disorders	Hepatobiliary disorders	TED/TED	2	37	2
other	Infections and Infestations	Infections and infestations	NT,PBO/TED	31	51	97
other	Infections and Infestations	Infections and infestations	TED/TED	26	37	62

1 to 10 of 190Source ClinicalTrials.gov

See all 190 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	NT,PBO/TED
Total, all-cause mortality	TED/TED
Total, other adverse events	NT,PBO/TED	49	51
Total, other adverse events	TED/TED	35	37
Total, serious adverse events	NT,PBO/TED	32	51
Total, serious adverse events	TED/TED	24	37

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
16099790	BACKGROUND	PubMed
32341691	DERIVED	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 comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
NT,PBO/TED vs TED/TED: serious adverse events

Source Trial comparisons

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.

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/NCT00930644

GET https://conductscience.org/api/trials/v1/NCT00930644/results?page=2

API reference For AI assistants