At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 88 enrolled
Drug / intervention
teduglutidedrug
Likely dose
teduglutide 0.05 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Long-Term, Open-Label Study With Teduglutide for Subjects With Parenteral Nutrition Dependent Short Bowel Syndrome
In Brief
A Phase 3 clinical trial evaluating teduglutide for Short Bowel Syndrome. Completed, enrolled 88 participants across 23 sites in 9 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShort Bowel Syndrome
CountriesCanada, Denmark, France, Germany, Italy, Poland, Spain, United Kingdom, United States
CollaboratorsNycomed Germany GmbH
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 2009
Enrollment StartSep 2009
Primary CompletionJan 2013
TodayJul 2026
First PostedJun 30, 2009
Enrollment StartSep 21, 2009
Primary CompletionJan 24, 2013
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.0 years ago
Interventions
teduglutidedrug
0.05 mg/kg/day subcutaneously taken once per day for 24 months