Clinical Trial Details

Overview

Research Study Summary

Irritable Bowel Syndrome with Constipation (IBS-C)

Purpose

SP304203-04 : Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IIBS-C).

To Learn more

CW ID: 210860
Date Last Changed: October 16, 2015

Clinical Trial Snapshot

Gender
Both Male and Female
Age
18 to 85 Years
Overall Status
Recruiting
Facility Type
N/A

Eligibility

Ages Eligible for Study: 18 Years to 85 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:

  • Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C

Exclusion Criteria:

  • Refusal or inability to sign informed consent for the trial
  • Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires
  • BMI > 35 or < 18
  • Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial
  • Women who are pregnant or lactating
  • Diagnosis of IBS-D or IBS-M
  • Organic or obstructive disease of the small or large intestine
  • Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl)
  • Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication
  • Unstable medical illness
  • Bilirubin > 3X ULN in the absence of a conjugation defect
  • Any laboratory value > 3X ULN unless discussed and approved by the study Medical Monitor

Contact

Christina Stahl, Executive Research Director
Quality Medical Research
330 Wallace Road, Suite 103
Nashville, TN 37211
Phone: 615-835-4750

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Research Center Information:

Quality Medical Research

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