Ignite Creation Date:
2024-05-06 @ 3:14 AM
Last Modification Date:
2024-10-26 @ 11:30 AM
Study NCT ID:
NCT02239510
Status:
TERMINATED
Last Update Posted:
2019-07-02
First Post:
2014-09-10
Brief Title:
Efficacy of Linaclotide to Senna for CIC
Sponsor:
TriHealth Inc
Organization:
TriHealth Inc
Study Overview
Official Title:
A Randomized Double-Blind Trial Comparing the Efficacy of Linaclotide to Senna in Relieving Symptoms in Patients With Chronic Idiopathic Constipation CIC
Status:
TERMINATED
Status Verified Date:
2018-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not sufficient recruitment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
In this prospective randomized double blind study the aim is to determine the efficacy of Linaclotide in relation to Senna in relieving the symptoms of chronic idiopathic constipation CIC Patients with CIC age 18 - 70 will be enrolled in the study and randomized to Senna or Linaclotide Patients will be asked to complete questionnaires during the study and will be followed for 12 weeks Main outcomes include number of daily bowel movements and measures from surveys regarding bowel habits relief and satisfaction
Detailed Description:
In this prospective randomized double blind study the aim is to determine the efficacy of Linaclotide in relation to Senna in relieving the symptoms of chronic idiopathic constipation CIC Our hypothesis is that Senna is not inferior to Linaclotide in the treatment of CIC Seventy patients aged 18-70 diagnosed with CIC and seen by a gastroenterologist affiliated with TriHealth or a patient of the Faculty Medical Center clinic will be included in the study After enrollment subjects will be randomized to receive either Linaclotide or Senna over a 12-week period after a 1 week wash-out period During th study period subjects will complete a log to record the number of daily bowel movements The subjects will also complete 3 validated surveys on a weekly basis Subjects Global Assessment SGA of Relief Subjects Global Assessment SGA of Bowel Habit and SGA of Satisfaction with their Bowel Habit A research nurse will meet with subjects at the beginning of the study and then at 3 monthly visits to administer the study medication and distribute the surveys The main outcomes measures are change in of bowel movements and SGA survey scores
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