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Efficacy of Linaclotide to Senna for CIC

Information source: TriHealth Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Idiopathic Constipation

Intervention: Senna (Drug); Linzess (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: TriHealth Inc.

Official(s) and/or principal investigator(s):
Mohd A AlSamman, MD, Principal Investigator, Affiliation: TriHealth Inc.

Overall contact:
Mohd A AlSamman, MD, Phone: 513-862-8205, Email: mohd_alsamman@trihealth.com

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.

Clinical Details

Official title: A Randomized, Double-Blind, Trial Comparing the Efficacy of Linaclotide to Senna in Relieving Symptoms in Patients With Chronic Idiopathic Constipation (CIC)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Change in number of daily bowel movements

Secondary outcome:

Change in assessment of relief

Change in assessment of bowel habit

Change in satisfaction with bowel habit

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 18-60 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.

Eligibility

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

Males and females 18 - 60 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)

Locations and Contacts

Mohd A AlSamman, MD, Phone: 513-862-8205, Email: mohd_alsamman@trihealth.com

TriHealth, Cincinnati, Ohio 45244, United States; Recruiting
Jenni Steinbrunner, BS, Phone: 513-862-4033, Email: jenni_steinbrunner@trihealth.com
Mohd A AlSamman, MD, Principal Investigator
Andrew Chun, MD, Sub-Investigator
Jenni Steinbrunner, BS, Sub-Investigator
Tom Imhoff, PharmD, Sub-Investigator
Truong Bui, MD, Sub-Investigator
Additional Information

Starting date: September 2014
Last updated: April 22, 2015

Page last updated: August 23, 2015

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