NCT00930644 is a Phase 3 clinical trial of teduglutide in Short Bowel Syndrome, sponsored by Shire.

Who is sponsoring NCT00930644?

NCT00930644 is sponsored by Shire.

What drugs are being tested in NCT00930644?

Interventions in NCT00930644: teduglutide.

What condition does NCT00930644 study?

NCT00930644 studies Short Bowel Syndrome.

Is NCT00930644 still recruiting?

NCT00930644 is currently completed. Last updated 11 June 2021.

Are results published for NCT00930644?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2021-06-11 · How we verify

NCT00930644

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 11 June 2021

What this trial tests

Phase 3 trial testing teduglutide in Short Bowel Syndrome in 88 participants. Completed in 24 January 2013.

Timeline

21 September 2009

Primary endpoint
24 January 2013

24 January 2013

Quick facts

Lead sponsor	Shire
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	88
Start date	21 September 2009
Primary completion	24 January 2013
Estimated completion	24 January 2013
Sites	23 locations across Denmark, France, Italy, United Kingdom, Germany, Poland, Canada, United States

Drugs / interventions tested

teduglutide (TEDUGLUTIDE) — full drug profile →

Conditions studied

Short Bowel Syndrome — all drugs for Short Bowel Syndrome →

Sponsor

Shire — full company profile →

Who can join

18 and older, any sex, with Short Bowel Syndrome. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percent Change in PN/IV Volume by Visit Primary · 24 months

The mean change from baseline in weekly PN.IV volume in percent change is shown by visit.

Month 1

Group	Value	95% CI
NT/TED	-5.35	± 11.287
PBO/TED	-6.44	± 11.241
TED/TED	-40.65	± 21.546

Month 2

Group	Value	95% CI
NT/TED	-12.88	± 22.789
PBO/TED	-10.27	± 14.027
TED/TED	-44.24	± 21.823

Month 3

Group	Value	95% CI
NT/TED	-10.83	± 47.396
PBO/TED	-14.18	± 16.440
TED/TED	-45.80	± 22.681

Month 6

Group	Value	95% CI
NT/TED	-24.13	± 17.496
PBO/TED	-16.48	± 20.979
TED/TED	-34.70	± 55.319

Month 9

Group	Value	95% CI
NT/TED	-25.35	± 17.855
PBO/TED	-20.95	± 27.500
TED/TED	-37.91	± 57.460

Month 12

Group	Value	95% CI
NT/TED	-23.33	± 20.296
PBO/TED	-22.00	± 33.858
TED/TED	-51.33	± 28.299

Month 15

Group	Value	95% CI
NT/TED	-31.62	± 25.901
PBO/TED	-18.89	± 33.165
TED/TED	-54.24	± 27.871

Month 18

Group	Value	95% CI
NT/TED	-35.11	± 35.545
PBO/TED	-24.18	± 32.183
TED/TED	-63.01	± 26.587

Absolute Change in PN/IV Volume by Visit Primary · 24 months

The mean change from baseline in weekly PN.IV volume in Liters is shown by visit.

Month 1

Group	Value	95% CI
NT/TED	-1.05	± 1.315
PBO/TED	-0.95	± 1.938
TED/TED	-5.28	± 3.819

Month 2

Group	Value	95% CI
NT/TED	-1.88	± 2.057
PBO/TED	-1.38	± 2.228
TED/TED	-5.62	± 3.873

Month 3

Group	Value	95% CI
NT/TED	-2.55	± 3.123
PBO/TED	-1.65	± 2.456
TED/TED	-5.72	± 3.771

Month 6

Group	Value	95% CI
NT/TED	-3.85	± 2.761
PBO/TED	-1.90	± 3.309
TED/TED	-5.20	± 4.650

Month 9

Group	Value	95% CI
NT/TED	-3.69	± 2.916
PBO/TED	-2.61	± 4.071
TED/TED	-5.59	± 4.899

Month 12

Group	Value	95% CI
NT/TED	-2.90	± 2.762
PBO/TED	-2.72	± 4.310
TED/TED	-6.36	± 4.633

Month 15

Group	Value	95% CI
NT/TED	-3.58	± 2.811
PBO/TED	-2.48	± 4.398
TED/TED	-6.37	± 4.261

Month 18

Group	Value	95% CI
NT/TED	-3.63	± 2.834
PBO/TED	-2.90	± 4.394
TED/TED	-6.99	± 4.048

Number of Subjects Achieving PN/IV Reduction Secondary · 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.

Achieving >= 1 Day of PN/IV Reduction

Group	Value	95% CI
NT/TED	3
PBO/TED	14
TED/TED	21

Achieving >= 2 Day of PN/IV Reduction

Group	Value	95% CI
NT/TED	2
PBO/TED	7
TED/TED	18

Achieving >= 3 Day of PN/IV Reduction

Group	Value	95% CI
NT/TED	2
PBO/TED	5
TED/TED	18

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected for each subject from the time informed consent was signed to the end of the study. The most commonly reported treatment emergent adverse events (>= 3% grouped at PT level) are listed.. Reporting threshold: 3%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

NT,PBO/TED

Serious: 32/51 (63%)

Deaths: —

TED/TED

Serious: 24/37 (65%)

Deaths: —

Serious adverse events (81 terms)

Reaction	System	NT,PBO/TED	TED/TED
Central line infection	Infections and infestations	—	—
Pyrexia	General disorders	—	—
Catheter bacteraemia	Infections and infestations	—	—
Catheter sepsis	Infections and infestations	—	—
Sepsis	Infections and infestations	—	—
Urinary tract infection	Infections and infestations	—	—
Catheter related infection	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—
Catheter site infection	Infections and infestations	—	—
Gastroenteritis	Infections and infestations	—	—
Gastrointestinal stoma complication	Injury, poisoning and procedural complications	—	—
Anaemia	Blood and lymphatic system disorders	—	—
Lymphadenitis	Blood and lymphatic system disorders	—	—
Cardiac failure congestive	Cardiac disorders	—	—
Tachycardia	Cardiac disorders	—	—
Crohns disease	Gastrointestinal disorders	—	—
Abdominal pain	Gastrointestinal disorders	—	—
Abdominal pain upper	Gastrointestinal disorders	—	—
Fecal volume increased	Gastrointestinal disorders	—	—
Intestinal obstruction	Gastrointestinal disorders	—	—
Melena	Gastrointestinal disorders	—	—
Pancreatitis acute	Gastrointestinal disorders	—	—
Papilla of Vater stenosis	Gastrointestinal disorders	—	—
Face oedema	General disorders	—	—
Injection site haematoma	General disorders	—	—

Other adverse events (14 terms — click to expand)

Reaction	System	NT,PBO/TED	TED/TED
Gastrointestinal Disorders	Gastrointestinal disorders	—	—
Infections and Infestations	Infections and infestations	—	—
General Disorders, and Administration Site Conditions	General disorders	—	—
Investigations	Investigations	—	—
Injury, Poisoning, and Procedural Complications	Injury, poisoning and procedural complications	—	—
Metabolism and Nutrition Disorder	Metabolism and nutrition disorders	—	—
Vascular Disorder	Vascular disorders	—	—
Musculoskeletal and Connective Tissue Disorders	Musculoskeletal and connective tissue disorders	—	—
Nervous System Disorders	Nervous system disorders	—	—
Respiratory, Thoracic, and Mediastinal Disorders	Respiratory, thoracic and mediastinal disorders	—	—
Hepatobiliary Disorders	Hepatobiliary disorders	—	—
Psychiatric Disorders	Psychiatric disorders	—	—
Renal and Urinary Disorders	Renal and urinary disorders	—	—
Blood and Lymphatic System Disorders	Blood and lymphatic system disorders	—	—

Most-reported serious reactions: Central line infection, Pyrexia, Catheter bacteraemia, Catheter sepsis, Sepsis, Urinary tract infection, Catheter related infection, Pneumonia.

Data from ClinicalTrials.gov NCT00930644 adverse events section.

Sponsor's own description

This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Long-Term Teduglutide for the Treatment of Patients With Intestinal Failure Associated With Short Bowel Syndrome.
Schwartz LK, O'Keefe SJ, Fujioka K, Gabe SM, et al · · 2016 · cited 132× · PMID 26844839 · DOI 10.1038/ctg.2015.69
Independence From Parenteral Nutrition and Intravenous Fluid Support During Treatment With Teduglutide Among Patients With Intestinal Failure Associated With Short Bowel Syndrome.
Iyer KR, Kunecki M, Boullata JI, Fujioka K, et al · · 2017 · cited 63× · PMID 27875291 · DOI 10.1177/0148607116680791
Reduction of Parenteral Nutrition and Hydration Support and Safety With Long-Term Teduglutide Treatment in Patients With Short Bowel Syndrome-Associated Intestinal Failure: STEPS-3 Study.
Seidner DL, Fujioka K, Boullata JI, Iyer K, et al · · 2018 · cited 57× · PMID 29761915 · DOI 10.1002/ncp.10092
Teduglutide for the treatment of adults with intestinal failure associated with short bowel syndrome: pooled safety data from four clinical trials.
Pape UF, Iyer KR, Jeppesen PB, Kunecki M, et al · · 2020 · cited 40× · PMID 32341691 · DOI 10.1177/1756284820905766
Enteral Autonomy and Days Off Parenteral Support With Teduglutide Treatment for Short Bowel Syndrome in the STEPS Trials.
Seidner DL, Gabe SM, Lee HM, Olivier C, et al · · 2020 · cited 23× · PMID 31423614 · DOI 10.1002/jpen.1687
Colon polyps in patients with short bowel syndrome before and after teduglutide: Post hoc analysis of the STEPS study series.
Armstrong D, Forbes A, Jeppesen PB, Lee HM, et al · · 2020 · cited 22× · PMID 31522784 · DOI 10.1016/j.clnu.2019.08.020
Changes in Parenteral Nutrition Requirements and BMI in Patients with Parenteral Nutrition-Dependent Short Bowel Syndrome after Stopping Teduglutide-9 Years of Follow-Up.
Zaczek Z, Jurczak-Kobus P, Panczyk M, Braszczyńska-Sochacka J, et al · · 2022 · cited 11× · PMID 35458196 · DOI 10.3390/nu14081634
An updated overview of glucagon-like peptide-2 analog trophic therapy for short bowel syndrome in adults.
Zhu C, Li Y. · · 2022 · cited 9× · PMID 35343263 · DOI 10.1177/03000605221086145

Verify or expand the search:

Other trials of teduglutide

Trials testing the same drug.

NCT01952080 — A Pharmacokinetic, Safety, and Pharmacodynamic Study of Teduglutide in Pediatric Subjects With Short Bowel Syndrome · Phase 3 · completed
NCT01209351 — Effect of Teduglutide on Gastric Emptying in Healthy Subjects · Phase 1 · completed
NCT00798967 — Study of Teduglutide Effectiveness in Parenteral Nutrition (PN)-Dependent Short Bowel Syndrome (SBS) Subjects · Phase 3 · completed
NCT00820885 — A Double-Blind Multi-Dose Tolerability and Pharmacokinetic Study of Teduglutide · Phase 1 · completed

Other recruiting trials for Short Bowel Syndrome

Currently open trials in the same condition.

NCT07197944 — Efficacy And Safety Evaluation of Glepaglutide in Treatment of SBS · Phase 3 · recruiting
NCT05535361 — A Feasibility Study to Evaluate Safety and Probable Benefit of the Eclipse XL1 System for Distraction Enterogenesis in A · NA · recruiting
NCT06973304 — A Study of Teduglutide in Chinese Adults With Short Bowel Syndrome · Phase 3 · recruiting
NCT06326645 — Open-Label Pilot Study With Crofelemer in Patients With Short Bowel Syndrome · EARLY_PHASE1 · recruiting
NCT06771505 — SBS DISK- Creation of a Quality of Life Tool for Short Bowel Patients Compared With a Validated Quality of Life Question · recruiting

Other Shire trials

Trials by the same sponsor.

NCT05067868 — A Study of Replagal in Children and Adults With Fabry Disease in India · Phase 4 · recruiting
NCT03878953 — A Clinical Study of rhPTH(1-84) Treatment in Japanese Participants With Chronic Hypoparathyroidism · Phase 3 · withdrawn
NCT04840667 — A Study of Replagal in Treatment-naïve Adults With Fabry Disease · Phase 3 · terminated
NCT04429984 — Post Marketing Surveillance (PMS) Study for Velaglucerase Alfa (VPRIV) in India · completed
NCT04440488 — ARALAST NP Alpha-1 Lung Density Chronic Obstructive Pulmonary Disease-Emphysema (COPD-E) Study · Phase 4 · withdrawn

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00930644 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Shire
Last refreshed: 11 June 2021

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00930644.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing