Status:
TERMINATED
Efficacy of Linaclotide to Senna for CIC
Lead Sponsor:
TriHealth Inc.
Conditions:
Chronic Idiopathic Constipation
Eligibility:
All Genders
18-70 years
Phase:
NA
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). Patien...
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 hy...
Eligibility Criteria
Inclusion
- Males and females 18 - 70 years of age. Diagnosed with CIC according to Rome III criteria. Coherent and mentally competent patient to understand and consent for the trial Unremarkable colonoscopy done in past 5 years
Exclusion
- Significant diarrhea (defined as loose or watery stool and or more than three bowel movements daily associated with urgency more than 25% of the days in preceding 3 months) Untreated hypothyroidism Organic or structural disease as the cause of patient's symptoms (stricture or tumor) Diseases that affect bowel transit time (Gastroparesis, short bowel syndrome) Evidence of cathartic colon History of alcohol, laxative abuse or illicit drug use Pregnant or lactating women Planning pregnancy or become pregnant during study period Concomitant use of any medication that could alter gastrointestinal motility (Calcium channel blockers, Narcotics, anticholinergics, calcium and aluminium containing antacids, phenothiazines, ferrous sulfate)
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02239510
Start Date
September 1 2014
End Date
June 1 2016
Last Update
July 2 2019
Active Locations (1)
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1
TriHealth
Cincinnati, Ohio, United States, 45220