Ignite Creation Date:
2024-05-06 @ 1:45 AM
Last Modification Date:
2024-10-26 @ 11:09 AM
Study NCT ID:
NCT01895543
Status:
COMPLETED
Last Update Posted:
2016-05-09
First Post:
2013-06-28
Brief Title:
Safety and Tolerability Extension Trial for Patients With Chronic Idiopathic Constipation
Sponsor:
Ferring Pharmaceuticals
Organization:
Ferring Pharmaceuticals
Study Overview
Official Title:
A Multicenter Open-label Safety and Tolerability Extension Trial of 5 mg and 10 mg Elobixibat Daily in the Treatment of Chronic Idiopathic Constipation
Status:
COMPLETED
Status Verified Date:
2016-04
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:
Safety and Tolerability Extension Trial for Patients with Chronic Idiopathic Constipation CIC
Detailed Description:
This was a Phase 3 multicenter open-label safety and tolerability extension trial of 10 mg elobixibat daily with possibility for dose adjustment to 5 mg daily for 52-week Treatment Period in patients with CIC A dose adjustment to 5 mgday was allowed for the remainder of the trial if a patient reported unacceptable treatment-related diarrhoea that occurred within the first four weeks of treatment
The trial enrolled patients from two lead-in double-blind efficacy trials trial codes NCT01827592 and NCT01833065
The trial enrolled patients from two lead-in double-blind efficacy trials trial codes NCT01827592 and NCT01833065
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 |
|---|---|---|---|
| 2012-005601-46 | EUDRACT_NUMBER | None | None |