Ignite Creation Date:
2024-05-06 @ 7:46 AM
Last Modification Date:
2024-10-26 @ 11:51 AM
Study NCT ID:
NCT02590432
Status:
COMPLETED
Last Update Posted:
2019-08-22
First Post:
2015-10-27
Brief Title:
An Open-Label Long-term Study to Assess the Immunogenicity of LINZESS Linaclotide Administered Orally to Adult Participants With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation
Sponsor:
Forest Laboratories
Organization:
Forest Laboratories
Study Overview
Official Title:
An Open-label Long-term Study to Assess the Immunogenicity of Linaclotide Administered Orally to Adult Patients With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation
Status:
COMPLETED
Status Verified Date:
2019-08
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 primary objective of this study is to assess the potential of LINZESS linaclotide treatment to induce the development of anti-drug antibodies ADAs The secondary objectives are to provide additional evidence supporting the long-term safety and efficacy of linaclotide in adult irritable bowel syndrome with constipation IBS-C and chronic idiopathic constipation CIC participants and to evaluate lower doses of linaclotide
Detailed Description:
This study includes up to a 3-week Screening Period followed by a 52-week treatment period Participants with CIC meeting the entry criteria received linaclotide 145 μg capsules orally once daily and participants with IBS-C meeting the entry criteria received linaclotide 290 μg capsules orally once daily Participants with intolerable Adverse Events AEs following resolution of the AEs could be randomized to receive 290 μg 145 μg or the lower dose of 72 μg linaclotide oral capsules for IBS-C and 145 μg or 72 μg for CIC Participants who experienced further intolerable AEs after the randomization could be transitioned to open-label 72 μg linaclotide
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