Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00172185Other idCL0600-005Other id2004-000439-27Other id2004

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 65 participants (actual)
Sponsor: Shire · Industry
Design: Randomized · Triple masking
Countries: 8 countries
United States, Belgium, Canada, Denmark, France, Netherlands, Poland, United Kingdom
Start: 10 Jan 2005
Primary completion: 24 Jan 2008
Completion: 24 Jan 2008
First posted: 15 Sept 2005 (estimated)
Last update posted: 2 Jun 2021
Conditions: Short Bowel Syndrome

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20052006200720082009

Ph 3
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
NCT00172185
10 Jan 2005 to 24 Jan 2008

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.

Interventions

teduglutide 0.05 mg/kg/dDrug
teduglutide 0.10 mg/kg/dDrug

Arms2

Experimental
teduglutide 0.05 mg/kg/d
0.05 mg/kg/d teduglutide subcutaneous injection
Experimental
teduglutide 0.10 mg/kg/d
0.10 mg/kg/d teduglutide subcutaneous injection

Primary outcomes1

Outcomes the sponsor listed as primary.

Number of Subjects Achieving a 20% Reduction at Week 28
Time frame · 28 weeks
Registry description
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 outcomes(1)

Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use
Time frame · 6 months
Registry description
Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use (Responder Status is Yes or No)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeNumber· 28 weeks

Number of Subjects Achieving a 20% Reduction at Week 28

Group	Value (Participants)
Placebo/0.05	5
Placebo/0.10	3
0.05/0.05	17
0.10/0.10	14

Secondary and other outcome results(1)

Secondary outcomeNumber· 6 months

Number of Subjects Who Achieved at Least a One-Day Reduction in Parenteral Nutrition (PN) Use

Group	Value (participants)
Placebo/0.05	4
Placebo/0.10	2
0.05/0.05	17
0.10/0.10	10

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Placebo/0.05Received placebo in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005	–	2 / 6	6 / 6
Placebo/0.10Received placebo in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005	–	3 / 7	7 / 7
0.05/0.05Received teduglutide 0.05 mg/kg/d in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005	–	13 / 25	22 / 25
0.10/0.10Received teduglutide 0.10 mg/kg/d in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005	–	9 / 27	26 / 27

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Randomized controlled trial · 2013

11 results

Safety and efficacy of teduglutide after 52 weeks of treatment in patients with short bowel intestinal failure.

O'Keefe et al. 2013Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Associationcited by 122

PMID 23333663DOI 10.1016/j.cgh.2012.12.029PUB-23333663

Full text at the publisher11 results

Publisher page See results (11)

Indexing hint: Randomized controlled trial · 2011

8 results

Randomised placebo-controlled trial of teduglutide in reducing parenteral nutrition and/or intravenous fluid requirements in patients with short bowel syndrome.

Jeppesen et al. 2011Gutcited by 323

PMID 21317170PMC3112364DOI 10.1136/gut.2010.218271PUB-21317170

Free to read · publisher termsCC BY-NC8 results

Read at source See results (8)

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

ResultVipperla K, O'Keefe SJ. Study of teduglutide effectiveness in parenteral nutrition-dependent short-bowel syndrome subjects. Expert Rev Gastroenterol Hepatol. 2013 Nov;7(8):683-7. doi: 10.1586/17474124.2013.842894. Epub 2013 Oct 17. PMID 24134154

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: At dosing week 24 of protocol CL0600-004 (NCT00081458), subjects will be reviewed for their participation in this study. Subjects who meet all of the following criteria can be enrolled in this study: * Signed and dated informed consent form (ICF) to participate before any study-related procedures are performed * Completion of protocol CL0600-004 (NCT00081458) Exclusion Criteria: * History of cancer or clinically significant lymphoproliferative disease with fewer than 5 years documented disease-free state * History of alcohol or drug abuse (within previous year) * Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of screening visit * Pregnant or lactating women * Any condition or circumstance, which in the investigator's opinion would put the subject at any undue risk, prevent completion of the study, or interfere with analysis of the study results

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