Trial · NCT00081458

Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome

NCT00081458, Phase 3, Completed, Shire; results first posted 2013-07-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome. Trials, record NCT00081458. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00081458

On this page

Trial

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

Title: Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome
NCT number: NCT00081458
Status: Completed
Phases: Phase 3
Enrollment: 84 participants, actual
Lead sponsor: Shire
Conditions: Short Bowel Syndrome
Interventions: Placebo, Teduglutide 0.05 mg/kg/d, Teduglutide 0.1 mg/kg/d
First posted: 2004-04-14
Last updated: 2021-06-09
Other registries' IDs: eudract:2004-000438-35
Results first posted: 2013-07-15

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	A Graded Response Score in Parenteral Nutrition (PN) Reduction	6 months	The intensity of the response relied on a reduction from Baseline in weekly parenteral nutrition (PN) volume (minimum reduction of 20% and a maximum of 100%). Duration of the response incorporated responses at Weeks(Wk) 16-20 and at Wk20-24. Zero (0 - lowest) assigned if \<20% reduction at Wk20-24 and reduction at Wk16-20 of \< 20%, 20-39%, or \>=40%. One (1) assigned if reduction of 20-39% at Wk20-24 but \< 20% at Wk16-20. Two(2) assigned if reductions of 40-99% at Wk20-24 AND \<20% at Wk16-20 OR 20-39% at Wk20-24 AND 20-39% at Wk16-20. Three (3) assigned if reductions of 100% at Wk20-24 AND \<20% at Wk16-20 OR 40-99% at Wk20-24 AND 20-39% at Wk16-20 OR 20-39% at Wk20-24 AND \>=40% at Wk16-20. Four (4) assigned if reductions of 100% at Wk20-24 AND 20-39% at Wk16-20 OR 40-99% at Wk20-24 AND \>=40% at Wk16-20.
Secondary	Number of Subjects Achieving Binary Response at Week 20, Maintained at Week 24	6 months of treatment	An efficacy responder was defined as achieving at least a 20% reduction from Baseline to Week 20 and maintained at Week 24 in weekly actual PN infusion volume.

Source ClinicalTrials.gov

Outcomes2

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	A Graded Response Score in Parenteral Nutrition (PN) Reduction	6 months	Intent to Treat (ITT) analysis using a stepdown procedure that was stopped if the 0.10 mg/kg dose was not significantly better than placebo.	participants	NUMBER
SECONDARY	Number of Subjects Achieving Binary Response at Week 20, Maintained at Week 24	6 months of treatment		participants	NUMBER

Source ClinicalTrials.gov

Results by group21

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

Outcome	Group	Category	Value	Units
A Graded Response Score in Parenteral Nutrition (PN) Reduction	Placebo	0 (No Response)	15	participants
A Graded Response Score in Parenteral Nutrition (PN) Reduction	Teduglutide 0.05 mg/kg/d	0 (No Response)	19	participants
A Graded Response Score in Parenteral Nutrition (PN) Reduction	Teduglutide 0.1 mg/kg/d	0 (No Response)	24	participants
A Graded Response Score in Parenteral Nutrition (PN) Reduction	Placebo	1	0	participants
A Graded Response Score in Parenteral Nutrition (PN) Reduction	Teduglutide 0.05 mg/kg/d	1	6	participants
A Graded Response Score in Parenteral Nutrition (PN) Reduction	Teduglutide 0.1 mg/kg/d	1	2	participants
A Graded Response Score in Parenteral Nutrition (PN) Reduction	Placebo	2	1	participants
A Graded Response Score in Parenteral Nutrition (PN) Reduction	Teduglutide 0.05 mg/kg/d	2	6	participants
A Graded Response Score in Parenteral Nutrition (PN) Reduction	Teduglutide 0.1 mg/kg/d	2	4	participants
A Graded Response Score in Parenteral Nutrition (PN) Reduction	Placebo	4	0	participants

1 to 10 of 21Source ClinicalTrials.gov

See all 21 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	16
Overall Study	STARTED	Teduglutide 0.05 mg/kg/d	35
Overall Study	STARTED	Teduglutide 0.1 mg/kg/d	33
Overall Study	Received Treatment	Placebo	16
Overall Study	Received Treatment	Teduglutide 0.05 mg/kg/d	35
Overall Study	Received Treatment	Teduglutide 0.1 mg/kg/d	32
Overall Study	COMPLETED	Placebo	15
Overall Study	COMPLETED	Teduglutide 0.05 mg/kg/d	27
Overall Study	COMPLETED	Teduglutide 0.1 mg/kg/d	29
Overall Study	NOT COMPLETED	Placebo	1

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events189

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	abdominal distension	Gastrointestinal disorders	Placebo	0	16	0
other	abdominal distension	Gastrointestinal disorders	Teduglutide 0.05 mg/kg/d	6	35	7
other	abdominal distension	Gastrointestinal disorders	Teduglutide 0.1 mg/kg/d	3	32	4
other	Abdominal pain	Gastrointestinal disorders	Placebo	2	16	2
other	Abdominal pain	Gastrointestinal disorders	Teduglutide 0.05 mg/kg/d	7	35	12
other	Abdominal pain	Gastrointestinal disorders	Teduglutide 0.1 mg/kg/d	9	32	11
other	diahrrea	Gastrointestinal disorders	Placebo	0	16	0
other	diahrrea	Gastrointestinal disorders	Teduglutide 0.05 mg/kg/d	0	35	0
other	diahrrea	Gastrointestinal disorders	Teduglutide 0.1 mg/kg/d	3	32	3
other	Dyspepsia	Gastrointestinal disorders	Placebo	1	16	1

1 to 10 of 189Source ClinicalTrials.gov

See all 189 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Teduglutide 0.05 mg/kg/d
Total, all-cause mortality	Teduglutide 0.1 mg/kg/d
Total, other adverse events	Placebo	15	16
Total, other adverse events	Teduglutide 0.05 mg/kg/d	33	35
Total, other adverse events	Teduglutide 0.1 mg/kg/d	31	32
Total, serious adverse events	Placebo	5	16
Total, serious adverse events	Teduglutide 0.05 mg/kg/d	13	35
Total, serious adverse events	Teduglutide 0.1 mg/kg/d	11	32

Source ClinicalTrials.gov

Papers6

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
1904648	BACKGROUND	PubMed
3109044	BACKGROUND	PubMed
8205419	BACKGROUND	PubMed
9352883	BACKGROUND	PubMed
21317170	RESULT	PubMed
27507402	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 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.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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GET https://conductscience.org/api/trials/v1/NCT00081458/results?page=2

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