Clinical Trial Details

Overview

Research Study Summary

A Phase 2b, Randomized, Double-blind, Double-dummy, Placebo-controlled, parallel-group, Dose-range-finding Study of Two Delayed Release Formulations of Linaclotide Adminsitered Orally for 12 Weeks to Patients with Irritable Bowel Syndrome with Constipation

Purpose

To evaluate the safety, efficacy, and dose response of 2 different delayed release formulations of Linaclotide administered orally to patients with irritable bowel syndrome.

To Learn more

CW ID: 214077
Date Last Changed: April 15, 2016

Clinical Trial Snapshot

Phase
2
Gender
Both Male and Female
Age
18 and up
Overall Status
Recruiting
Lead Sponsor
Ironwood
Duration
4 Months
Facility Type
Out-Patient

Eligibility

Inclusion Criteria:
  • Symptoms of IBS-C for at least 6 months prior to diagnosis (abdominal pain, hard/lumpy stools) < 3 BM's per week for at least 12 weeks prior to screening
  • Patients age 50 years and older must have had a colonoscopy with negative findings during the 10 years before screening
  • Willing to discontinue laxatives throughout the trial
Exclusion Criteria:
  • Reports loose/watery stools without laxatives
  • Any history or family history of colon cancer
  • Has ever been diagnosed with inflammatory bowel disease
  • History of diverticulitis or any chronic condition (pancreatitis, polycystic kidney disease, ovarian cysts, endometriosis) unless cured from the condition.
  • Has ever had a bowel obstruction or fecal impaction that required hospitalization or ER treatment
  • Patient has taken commercially available linaclotide or participated in a linaclotide, plecanatide, or SP-333 clinical trial study during the 30 days before screening visit

More Info

Only 6 scheduled visits to clinic, rest are phone calls
  • IP is already on market as immediate release Linzess, this is a delayed release formula
  • Oral treatment
  • Will have rescue medication (bisacodyl)

Contact

Bobbi Duffy-Hidalgo APRN, Clinical Research Coordinator/ Sub-Investigator
Chase Medical Research, LLC
500 Chase Parkway 3rd Floor
Waterbury, CT 06708
Phone: 203-721-6040
Fax: 203-465-7924

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Research Center Information:

Chase Medical Research, LLC

Volunteer for this Trial

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