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

NCT00081458 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2021-06-09

Study results available
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Summary

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).

Conditions

  • Short Bowel Syndrome

Interventions

DRUG

Placebo

placebo injectable subcutaneously daily into thigh or abdomen

DRUG

Teduglutide 0.05 mg/kg/d

Teduglutide 0.05 mg/kg/d daily injectable subcutaneously into the thigh or abdomen

DRUG

Teduglutide 0.1 mg/kg/d

Teduglutide 0.1 /g/kg/d daily injection subcutaneously into thigh or abdomen

Sponsors & Collaborators

  • Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-25
Primary Completion
2007-07-06
Completion
2007-07-06

Countries

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

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00081458 on ClinicalTrials.gov