At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 65 enrolled
Drug / intervention
teduglutide 0.05 mg/kg/d +1 moredrug
Likely dose
Teduglutide 0.05 mg/kg/day or 0.10 mg/kg/day subcutaneous injectionAI-extracted
Key inclusion· 2
- ✓Completion of protocol CL0600-004 (NCT00081458)
- ✓Signed and dated informed consent form before any study-related procedures
Key exclusion· 4
- ✕History of cancer or clinically significant lymphoproliferative disease unless documented disease-free for at least 5 years
- ✕Prior use of native glucagon-like peptide 2 (GLP-2) within 3 months of screening visit
- ✕History of alcohol or drug abuse within the previous year
- ✕Pregnant or lactating women
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Study of the Safety and Efficacy of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome Who Completed Protocol CL0600-004 (NCT00081458)
In Brief
A Phase 3 clinical trial evaluating teduglutide 0.05 mg/kg/d and teduglutide 0.10 mg/kg/d for Short Bowel Syndrome. Completed, enrolled 65 participants across 21 sites in 8 countries.
Detailed Summary
The purpose of this clinical study is to evaluate the long-term safety and efficacy of daily administration of teduglutide.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsShort Bowel Syndrome
CountriesBelgium, Canada, Denmark, France, Netherlands, Poland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2005
First PostedSep 2005
Primary CompletionJan 2008
TodayJul 2026
First PostedSep 15, 2005
Enrollment StartJan 10, 2005
Primary CompletionJan 24, 2008
TodayJul 2, 2026
Enrollment to primary: 3.0 yearsPosted 20.8 years ago
Interventions
teduglutide 0.05 mg/kg/ddrug
0.05 mg/kg/d subcutaneous injection
teduglutide 0.10 mg/kg/ddrug
0.10 mg/kg/d subcutaneous injection