Ph2a Study to Evaluate IW-3718 in Patients With Gastroesophageal Reflux Not Completely Responsive to Proton Pump Inhibitors

Gastroesophageal Reflux Clinical Trial

Official title:

A Phase 2a Study to Evaluate the Effect of IW-3718 Administered Orally for 4 Weeks in Patients With GERD Not Completely Responsive to Proton Pump Inhibitors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02030925
• Other study ID #: ICP-3718-201
• Status: Completed
• Phase: Phase 2
• First received: December 19, 2013
• Last updated: July 28, 2016
• Start date: February 2014
• Est. completion date: December 2014

Study information

• Verified date: July 2016
• Source: Ironwood Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is meant to assess the effect of IW-3718 as an added treatment to ongoing once-daily protocol pump inhibitor (PPI) treatment for patients who continue to experience symptoms of their gastroesophageal reflux disease (GERD).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient is between 18 and 65 years of age at the Screening Visit; females must not be pregnant or must not be breastfeeding;

• Patient has a confirmed diagnosis of gastroesophageal reflux disease, must be currently taking a proton pump inhibitor (PPI), and must be experiencing GERD symptoms as specified by the protocol.

Exclusion Criteria:

• Patient may not meet any of the excluded conditions specified in the protocol;

• Patient is experiencing alarm symptoms such as GI bleeding, anemia, vomiting, dysphagia, or unexpected weight loss;

• Patient has a clinically significant hypersensitivity or allergies to any of the active ingredients or excipients in the study medication.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gastroesophageal Reflux

Intervention

Drug:
• IW-3718

• Matching Placebo

Locations

Country	Name	City	State
United States	Ironwood Investigational Site	Anaheim	California
United States	Ironwood Investigational Site	Chattanooga	Tennessee
United States	Ironwood Investigational Site	Chesterfield	Michigan
United States	Ironwood Investigational Site	Cleveland	Ohio
United States	Ironwood Investigational Site	Logan	Utah
United States	Ironwood Investigational Site	Monroe	Louisiana
United States	Ironwood Investigational Site	Nashville	Tennessee
United States	Ironwood Investigational Site	North Little Rock	Arkansas
United States	Ironwood Investigational Site	Raleigh	North Carolina
United States	Ironwood Investigational Site	South Ogden	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Ironwood Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exploratory Endpoints - GERD Symptoms		Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period	No