Clinical Trial Details

Overview

Research Study Summary

A Second Phase 3 Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients with Irritable Bowel Syndrome with Constipation (IBS-C)

Purpose

The purpose of the study is to evaluate the safety and effectiveness of plecanatide for the treatment of IBS-C.

To Learn more

CW ID: 213292
Date Last Changed: February 16, 2016

Clinical Trial Snapshot

Phase
3
Gender
Both Male and Female
Age
18 to 85 Years
Overall Status
Recruiting
Lead Sponsor
Synergy Pharmaceutical
Duration
12 Weeks
Facility Type
Out-Patient
Compensation
Up to $300

Eligibility

Inclusion Criteria:

  • Patients with symptoms or a diagnosis of Irritable Bowel Syndrome with Constipation (IBS-C)

Exclusion Criteria:

  • Is on Linzess or Amitiza within 15 days of screening
  • Body Mass Index (BMI) <18 or >40 kg/m
  • History of IBD (e.g. Crohn's disease or Ulcerative Colitis)
  • History of a fecal impaction, requiring an intervention within the last 3 months
  • A medical illness that is predominantly characterized by chronic abdominal pain (e.g. untreated endometriosis, chronic ovarian cysts, painful menses, GERD, chronic pancreatitis)
  • History of or current structural abnormality of the GI tract or a disease that can affect GI motility (e.g. bowel obstruction, untreated abdominal adhesions, lactose intolerance, laxative or enema abuse, anal fissure)

Contact

Crystal Beaber, MA, CCRC, Senior Clinical Research Coordinator
Gastroenterology Associates of Tidewater
112 Gainsborough Square; Suite 200
Chesapeake, VA 23320
Phone: 757-547-0798; ext. 1131
Fax: 757-410-4123

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Research Center Information:

Gastroenterology Associates of Tidewater

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