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

NCT00172185 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2021-06-02

Study results available
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Summary

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

Conditions

  • Short Bowel Syndrome

Interventions

DRUG

teduglutide 0.05 mg/kg/d

0.05 mg/kg/d subcutaneous injection

DRUG

teduglutide 0.10 mg/kg/d

0.10 mg/kg/d subcutaneous injection

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
2005-01-10
Primary Completion
2008-01-24
Completion
2008-01-24

Countries

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

Study Locations

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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 NCT00172185 on ClinicalTrials.gov