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NCT00172185 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study, sponsored by Shire.

Completed
Registry status
Phase 3
Development phase
65
Enrollment target

NCT00172185: Completed Phase 3 study, sponsored by Shire.

NCT00172185 is a Phase 3 study that has completed, run by Shire. The registered enrollment target is 65 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00172185, a Phase 3 study, has completed, sponsored by Shire.

COMPLETED
Registry status
Phase 3
Development phase
65 participants
Enrollment target

Study Summary

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

Primary Outcome

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.

Interventions

  • DRUG teduglutide 0.05 mg/kg/d
  • DRUG teduglutide 0.10 mg/kg/d

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2005-01-10
Est. Completion 2008-01-24
Phase Phase 3
Shire

245 total trials

What the finished NCT00172185 record still lists

NCT00172185 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (92% lower).

The record links to 0 conditions, and to 2 interventions - of which teduglutide 0.05 mg/kg/d is the first listed.

NCT00172185 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00172185 about?

NCT00172185 is a clinical study titled "Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)". The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.

What is the current status of trial NCT00172185?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 65 participants. The study started on 2005-01-10. Estimated completion is 2008-01-24.

What interventions are being tested in trial NCT00172185?

The interventions under investigation include: teduglutide 0.05 mg/kg/d (DRUG), teduglutide 0.10 mg/kg/d (DRUG).

Who is sponsoring clinical trial NCT00172185?

This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00172185's enrollment target sits among peer trials

65 1797th of 2000 higher than 202 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00172185, the US trial registry maintained by the National Library of Medicine. NCT00172185 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.