Ignite Creation Date:
2024-05-06 @ 3:28 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02291679
Status:
COMPLETED
Last Update Posted:
2017-06-15
First Post:
2014-11-11
Brief Title:
Trial of Linaclotide in Patients With Chronic Idiopathic Constipation
Sponsor:
Ironwood Pharmaceuticals Inc
Organization:
Ironwood Pharmaceuticals Inc
Study Overview
Official Title:
A Phase 3 Randomized Double-blind Placebo-controlled Parallel-group Trial of Linaclotide 72 ug or 145 ug Administered Orally for 12 Weeks to Patients With Chronic Idiopathic Constipation
Status:
COMPLETED
Status Verified Date:
2017-05
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 objective of this trial was to determine the efficacy and safety of linaclotide 72 ug administered once daily to patients with chronic idiopathic constipation CIC The primary efficacy parameter is the percentage of participants in each dosing group that meet the protocol definition for complete spontaneous bowel movement CSBM Overall Responder
Detailed Description:
The trial also included a 145 ug linaclotide treatment arm an FDA-approved dose for CIC as an established positive control to validate the study design
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