Efficacy of Linaclotide to Senna for CIC

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.

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 trial
Unremarkable colonoscopy done in past 5 years

Exclusion Criteria:

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)