Efficacy of Linaclotide to Senna for CIC

Phase

N/A

Condition

Irritable Bowel Syndrome (Ibs)

Constipation

Treatment

N/A

Clinical Study ID

NCT02239510

14040

Ages 18-70
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria: 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 trialUnremarkable colonoscopy done in past 5 years

Exclusion

Exclusion Criteria: Significant diarrhea (defined as loose or watery stool and or more than three bowelmovements 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 bowelsyndrome) Evidence of cathartic colon History of alcohol, laxative abuse or illicit druguse Pregnant or lactating women Planning pregnancy or become pregnant during study periodConcomitant use of any medication that could alter gastrointestinal motility (Calciumchannel blockers, Narcotics, anticholinergics, calcium and aluminium containing antacids,phenothiazines, ferrous sulfate)

Study Design

September 01, 2014

June 30, 2016

Study 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: Subject's Global Assessment SGA of Relief, Subject's 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.

Connect with a study center

TriHealth
Cincinnati, Ohio 45220
United States
Site Not Available

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