Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00081458
Status:
COMPLETED
Last Update Posted:
2021-06-09
First Post:
2004-04-13
Brief Title:
Safety and Efficacy Study of Teduglutide in Subjects With Short Bowel Syndrome
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
A Study of the Efficacy and Safety of Teduglutide in Subjects With Parenteral Nutrition-Dependent Short Bowel Syndrome
Status:
COMPLETED
Status Verified Date:
2021-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the efficacy safety tolerability and pharmacokinetics PK of teduglutide compared with placebo in subjects with parenteral nutrition PN-dependent short bowel syndrome SBS
Detailed Description:
Teduglutide is an analog of glucagon-like peptide 2 GLP-2 a naturally occurring hormone that regulates the growth proliferation and maintenance of cells lining the gastrointestinal tract Teduglutide has been shown in animal studies and previous human clinical trials to increase the size and number of these cells thereby increasing the absorptive surface area of the intestines
The multicenter double-blind international Phase III trial will randomly assign approximately 80 patients to receive daily subcutaneous injections of 005 milligrams or 010 milligrams of teduglutide per kilogram of body weight or a placebo Dosing will continue for a period of six months The primary endpoint in the study is a reduction in the use of intravenous feeding which is often required to sustain life in patients with SBS
The multicenter double-blind international Phase III trial will randomly assign approximately 80 patients to receive daily subcutaneous injections of 005 milligrams or 010 milligrams of teduglutide per kilogram of body weight or a placebo Dosing will continue for a period of six months The primary endpoint in the study is a reduction in the use of intravenous feeding which is often required to sustain life in patients with SBS
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-000438-35 | EUDRACT_NUMBER | None | None |