Trial · NCT00172185

Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)

NCT00172185, Phase 3, Completed, Shire; results first posted 2013-04-23

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 Who Completed Protocol CL0600-004 (NCT00081458). Trials, record NCT00172185. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00172185

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 Who Completed Protocol CL0600-004 (NCT00081458)
NCT number: NCT00172185
Status: Completed
Phases: Phase 3
Enrollment: 65 participants, actual
Lead sponsor: Shire
Conditions: Short Bowel Syndrome
Interventions: teduglutide 0.05 mg/kg/d, teduglutide 0.10 mg/kg/d
First posted: 2005-09-15
Last updated: 2021-06-02
Other registries' IDs: eudract:2004-000439-27
Results first posted: 2013-04-23

Source ClinicalTrials.gov

Registered outcomes2

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

List	Outcome	Time frame	Description
Primary	Number of Subjects Achieving a 20% Reduction at Week 28	28 weeks	For those subjects who received teduglutide (0.05 or 0.10 mg dose) in Study 004 and the same in Study 005, Parenteral Nutrition (PN) Use at Week 28 was compared to the Baseline Visit of Study 004 to calculate the 20% reduction in PN Use. For those subjects who received placebo in Study 004 and either teduglutide 0.05 or 0.10 mg dose in Study 005, PN Use at Week 28 was compared to the use of PN at Week 24 of Study 004 to calculate the 20% reduction in PN Use.
Secondary	Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use	6 months	Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use (Responder Status is Yes or No)

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	Number of Subjects Achieving a 20% Reduction at Week 28	28 weeks	Number of participants for analysis was determined based on completing all of the prerequisite visits in Study 005. Subjects who dropped out of the study were considered failures.	Participants	NUMBER
SECONDARY	Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use	6 months	Response Status is Yes or No	participants	NUMBER

Source ClinicalTrials.gov

Results by group12

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

Outcome	Group	Category	Value	Units
Number of Subjects Achieving a 20% Reduction at Week 28	Placebo/0.05		5	Participants
Number of Subjects Achieving a 20% Reduction at Week 28	Placebo/0.10		3	Participants
Number of Subjects Achieving a 20% Reduction at Week 28	0.05/0.05		17	Participants
Number of Subjects Achieving a 20% Reduction at Week 28	0.10/0.10		14	Participants
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use	Placebo/0.05	Response Status: Yes	4	participants
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use	Placebo/0.10	Response Status: Yes	2	participants
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use	0.05/0.05	Response Status: Yes	17	participants
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use	0.10/0.10	Response Status: Yes	10	participants
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use	Placebo/0.05	Response Status: No	2	participants
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use	Placebo/0.10	Response Status: No	5	participants

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo/0.05	6
Overall Study	STARTED	Placebo/0.10	7
Overall Study	STARTED	0.05/0.05	25
Overall Study	STARTED	0.10/0.10	27
Overall Study	COMPLETED	Placebo/0.05	6
Overall Study	COMPLETED	Placebo/0.10	5
Overall Study	COMPLETED	0.05/0.05	20
Overall Study	COMPLETED	0.10/0.10	23
Overall Study	NOT COMPLETED	Placebo/0.05	0
Overall Study	NOT COMPLETED	Placebo/0.10	2

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events244

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	Cardiac disorders	Cardiac disorders	Placebo/0.05	0	6	0
other	Cardiac disorders	Cardiac disorders	Placebo/0.10	0	7	0
other	Cardiac disorders	Cardiac disorders	0.05/0.05	2	25	2
other	Cardiac disorders	Cardiac disorders	0.10/0.10	1	27	1
other	Abdominal discomfort	Gastrointestinal disorders	Placebo/0.05	1	6	1
other	Abdominal discomfort	Gastrointestinal disorders	Placebo/0.10	0	7	0
other	Abdominal discomfort	Gastrointestinal disorders	0.05/0.05	1	25	1
other	Abdominal discomfort	Gastrointestinal disorders	0.10/0.10	1	27	3
other	Abdominal distension	Gastrointestinal disorders	Placebo/0.05	1	6	1
other	Abdominal distension	Gastrointestinal disorders	Placebo/0.10	1	7	1

1 to 10 of 244Source ClinicalTrials.gov

See all 244 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo/0.05
Total, all-cause mortality	Placebo/0.10
Total, all-cause mortality	0.05/0.05
Total, all-cause mortality	0.10/0.10
Total, other adverse events	Placebo/0.05	6	6
Total, other adverse events	Placebo/0.10	7	7
Total, other adverse events	0.05/0.05	22	25
Total, other adverse events	0.10/0.10	26	27
Total, serious adverse events	Placebo/0.05	2	6
Total, serious adverse events	Placebo/0.10	3	7

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers3

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
21317170	RESULT	PubMed
23333663	RESULT	PubMed
24134154	RESULT	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.

GET https://conductscience.org/api/trials/v1/NCT00172185

GET https://conductscience.org/api/trials/v1/NCT00172185/events?page=2

API reference For AI assistants