Trial · NCT00798967

Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects

NCT00798967, Phase 3, Completed, Shire; results first posted 2012-02-01

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects. Trials, record NCT00798967. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00798967

On this page

Trial

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

Title: Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects
NCT number: NCT00798967
Status: Completed
Phases: Phase 3
Enrollment: 86 participants, actual
Lead sponsor: Shire
Conditions: Short Bowel Syndrome
Interventions: teduglutide, placebo
First posted: 2008-11-27
Last updated: 2021-06-03
Other registries' IDs: eudract:2008-006193-15
Results first posted: 2012-02-01

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Responder	Weeks 20 and 24	Comparison of subjects treated with teduglutide to placebo who achieve a 20 to 100% reduction from baseline in weekly parenteral nutrition/intravenous fluid (PN/I.V.) volume at weeks 20 and 24.
Secondary	Absolute Change in PN/I.V. Volume From Baseline to Last Time Point	Week 0 to last visit when data was collected.	Absolute change in the volume of PN/I.V. from baseline (Week 0) to the visit when the last data point was collected (week 4 through week 24, or earlier if the subject discontinued early).

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	Responder	Weeks 20 and 24	Percentages were based on the number of subjects in the Intent to Treat (ITT) population.	subjects	NUMBER
SECONDARY	Absolute Change in PN/I.V. Volume From Baseline to Last Time Point	Week 0 to last visit when data was collected.	Intent-to-Treat (ITT) was defined for efficacy analyses which included all randomized patients.	Liters/Week	MEAN

Source ClinicalTrials.gov

Results by group4

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

Outcome	Group	Value	Spread	Units
Responder	Teduglutide	27		subjects
Responder	Placebo	13		subjects
Absolute Change in PN/I.V. Volume From Baseline to Last Time Point	Teduglutide	-4.28	Standard Deviation 3.81	Liters/Week
Absolute Change in PN/I.V. Volume From Baseline to Last Time Point	Placebo	-2.38	Standard Deviation 2.79	Liters/Week

Source ClinicalTrials.gov

Participant flow8

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Teduglutide	43
Overall Study	STARTED	Placebo	43
Overall Study	Discontinued During Dosing Period	Teduglutide	4
Overall Study	Discontinued During Dosing Period	Placebo	4
Overall Study	COMPLETED	Teduglutide	39
Overall Study	COMPLETED	Placebo	39
Overall Study	NOT COMPLETED	Teduglutide	4
Overall Study	NOT COMPLETED	Placebo	4

Source ClinicalTrials.gov

Adverse events84

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	Teduglutide	9	42	14
other	Abdominal distension	Gastrointestinal disorders	Placebo	1	43	2
other	Abdominal pain	Gastrointestinal disorders	Teduglutide	13	42	14
other	Abdominal pain	Gastrointestinal disorders	Placebo	10	43	14
other	Central line systemic infections	Infections and infestations	Teduglutide	7	42	12
other	Central line systemic infections	Infections and infestations	Placebo	7	43	8
other	Diarrhea	Gastrointestinal disorders	Teduglutide	3	42	4
other	Diarrhea	Gastrointestinal disorders	Placebo	5	43	7
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Teduglutide	3	42	3
other	Dyspnea	Respiratory, thoracic and mediastinal disorders	Placebo	0	43	0

1 to 10 of 84Source ClinicalTrials.gov

See all 84 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Teduglutide
Total, all-cause mortality	Placebo
Total, other adverse events	Teduglutide	35	42
Total, other adverse events	Placebo	34	43
Total, serious adverse events	Teduglutide	15	42
Total, serious adverse events	Placebo	12	43

Source ClinicalTrials.gov

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
16099790	RESULT	PubMed
22982184	DERIVED	PubMed
23274148	DERIVED	PubMed
23587733	DERIVED	PubMed
24134154	DERIVED	PubMed
27507402	DERIVED	PubMed
29174926	DERIVED	PubMed
31784300	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
Teduglutide vs Placebo: 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/NCT00798967

GET https://conductscience.org/api/trials/v1/NCT00798967/events?page=2

API reference For AI assistants