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Efficacy of Linaclotide to Senna for CIC

NCT02239510 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2019-07-02

Study results available
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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.

Conditions

  • Chronic Idiopathic Constipation

Interventions

DRUG

Senna

1 capsule (50 mg) Senna daily for 12 weeks

DRUG

Linzess

1 capsule (145 mcg) of Linzess once daily for 12 weeks

Sponsors & Collaborators

  • TriHealth Inc.

    lead OTHER

Principal Investigators

  • Mohd A AlSamman, MD · TriHealth Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2016-06-30
Completion
2016-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02239510 on ClinicalTrials.gov