Phase 3 N=88 Treatment

Open-Label Study of Teduglutide for Subjects With PN-Dependent Short Bowel Syndrome (SBS)

Short Bowel Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT00930644 ↗

Enrolled (actual)

Serious AEs

63.6%

Results posted

Dec 2014

Primary outcome: Primary: Percent Change in PN/IV Volume by Visit — -5.35; -6.44; -40.65; -12.88 percent change

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: teduglutide (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Shire
Primary completion: Jan 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change in PN/IV Volume by Visit	-5.35; -6.44; -40.65; -12.88; -10.27; -44.24	—
PRIMARY Absolute Change in PN/IV Volume by Visit	-1.05; -0.95; -5.28; -1.88; -1.38; -5.62	—
SECONDARY Number of Subjects Achieving PN/IV Reduction	3; 14; 21; 2; 7; 18	—

Summary

This study is a 2-year open label extension study to collect long term efficacy and safety data from patients who have completed the 24-weeks of study drug dosing in CL0600-020.

Eligibility Criteria

Inclusion Criteria

must have completed 24 weeks of dosing of the CL0600-020 study

Exclusion Criteria

none

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00930644). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.