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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

NCTNCT00081458 (opens ClinicalTrials.gov in a new tab)Other idCL0600-004Other id2004-000438-35Other id2004
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
84 participants (actual)
Sponsor
Shire · Industry
Design
Randomized · Triple masking
Countries
9 countries

United States, Belgium, Canada, Denmark, France, Germany, Netherlands, Poland, United Kingdom

Start
25 May 2004
Primary completion
6 Jul 2007
Completion
6 Jul 2007
First posted
14 Apr 2004 (estimated)
Last update posted
9 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
20042005200620072008
  1. Ph 3

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

    NCT00081458

    25 May 2004 to 6 Jul 2007

Registry summary

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

The purpose of this study is to evaluate the efficacy, safety, tolerability, and pharmacokinetics (PK) of teduglutide compared with placebo in subjects with parenteral nutrition (PN)-dependent short bowel syndrome (SBS).

Interventions

  • PlaceboDrug
  • Teduglutide 0.05 mg/kg/dDrug
  • Teduglutide 0.1 mg/kg/dDrug

Arms3

  • Placebo comparator

    placebo

    Placebo injectable subcutaneously daily into the thigh or abdomen

  • Experimental

    2

    teduglutide 0.05 mg/kg/d

  • Experimental

    3

    teduglutide 0.1 mg/kg/d

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. A Graded Response Score in Parenteral Nutrition (PN) Reduction

    Time frame · 6 months

    Registry description

    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 outcomes(1)

  1. Number of Subjects Achieving Binary Response at Week 20, Maintained at Week 24

    Time frame · 6 months of treatment

    Registry description

    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.

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· 6 months

A Graded Response Score in Parenteral Nutrition (PN) Reduction

GroupValue (participants)
Placebo15
Teduglutide 0.05 mg/kg/d19
Teduglutide 0.1 mg/kg/d24
Secondary and other outcome results(1)
Secondary outcomeNumber· 6 months of treatment

Number of Subjects Achieving Binary Response at Week 20, Maintained at Week 24

GroupValue (participants)
Placebo1
Teduglutide 0.05 mg/kg/d16
Teduglutide 0.1 mg/kg/d8

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboPlacebo injected subcutaneously daily–5 / 1615 / 16
Teduglutide 0.05 mg/kg/dteduglutide 0.05 mg/kg/d injected subcutaneously–13 / 3533 / 35
Teduglutide 0.1 mg/kg/dteduglutide 0.1 mg/kg/d injected subcutaneously–11 / 3231 / 32

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 · 2017

2 results

Patients With Short Bowel on Narcotics During 2 Randomized Trials Have Abdominal Complaints Independent of Teduglutide.

Fujioka et al. 2017JPEN. Journal of parenteral and enteral nutritioncited by 10

PMID 27507402PMC5703028DOI 10.1177/0148607116663481PUB-27507402

CC BY2 results
Download PDFSee results (2)

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 sourceSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Men and women, aged 18 years of age or older at the time of signing the informed consent form (ICF) * SBS as a result of major intestinal resection resulting in at least 12 months intravenous feeding * Body weight must be less than 90 kg * At baseline, subjects must require PN treatment to meet their caloric or electrolyte needs due to ongoing malabsorption at least 3 times weekly and to be on a stable PN regimen for 4 weeks before dosing * Body mass index (BMI) 18 to 27 kg/m2 * Adequate hepatic and renal function 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) * Participation in a clinical study within 30 days prior to signing the ICF, or concurrent participation in any clinical study * Clinically significant laboratory abnormalities at the time of randomization * Previous use of teduglutide (ALX-0600) * Prior use of native GLP-2 within 3 months of screening visit * Hospital admission within 1 month prior to 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. * Presence of excluded disease: Radiation enteritis, Scleroderma, Celiac disease, Refractory/Tropical sprue, Pseudo-obstruction, Active inflammatory bowel disease (IBD), Pre-malignant/malignant change in colonoscopy biopsy or polypectomy, Surgery scheduled within the time frame of the study, Human immunodeficiency virus (HIV) positive test, Immunological disorders, Possible allergies to teduglutide or its constituents, Significant, active, uncontrolled, untreated systemic diseases

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