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 reliefChange 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
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