Efficacy of Linaclotide to Senna for CIC

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

Study Overview

• Status: Terminated
• Conditions: Chronic Idiopathic Constipation
• Intervention / Treatment: Drug: Senna; Drug: Linzess

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 18-70 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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45220
      • TriHealth

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Senna; 1 capsule (50 mg) Senna daily for 12 weeks	Drug: Senna; 1 capsule (50 mg) Senna daily for 12 weeks; Other Names: sennoside
Active Comparator: Linzess; 1 capsule (145 mcg) once daily for 12 weeks	Drug: Linzess; 1 capsule (145 mcg) of Linzess once daily for 12 weeks; Other Names: Linaclotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Number of Bowel Movements Per Week	Change from before to after in number of weekly bowel movements	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Relief	Change from before to after treatment in patient assessment of relief - The Subject's Global Assessment (SGA) of Relief was used to measure this outcome. In evaluating subject's response to SGA of relief, subject's who respond with either "completely relieved" or "considerably relieved" for at least 50% of the weeks at the end point or "somewhat relieved" for 100 % of the weeks at the end point will be considered responders to therapy.	12 weeks
Change in Assessment of Bowel Habit	Change from before treatment to after treatment in assessment of bowel habit The Subject's Global Assessment (SGA) of Bowel Habit was used to measure this outcome. Patients were asked how bothersome their constipation was in the past week on a scare from 0 (Absent) to 100 (Very Severe).	12 weeks
Change in Satisfaction With Bowel Habit	Change from before treatment to after treatment on patient satisfaction with bowel habit The Subject's Global Assessment (SGA) of Satisfaction with Bowel Habit was used to measure this outcome. Patients were asked how satisfied they have been with their bowel habits in the previous week on a scale of 0 (Unsatisfied) to 100 (Very Satisfied).	12 weeks

Collaborators and Investigators

• Sponsor: TriHealth Inc.
• Investigators: Principal Investigator: Mohd A AlSamman, MD, TriHealth Inc.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: September 10, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimate): September 12, 2014

Study Record Updates

• Last Update Posted (Actual): July 2, 2019
• Last Update Submitted That Met QC Criteria: June 12, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: constipation; bowel habits
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Constipation; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Guanylyl Cyclase C Agonists; Enzyme Activators; Laxatives; Linaclotide; Sennosides
• Other Study ID Numbers: 14040

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Recruitment was low and therefore results are insufficient to share.