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

July 28, 2016 updated by: Ironwood Pharmaceuticals, Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

93

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Ironwood Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Ironwood Investigational Site
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Ironwood Investigational Site
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Ironwood Investigational Site
    • North Carolina
      • Raleigh, North Carolina, United States, 27612
        • Ironwood Investigational Site
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • Ironwood Investigational Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Ironwood Investigational Site
      • Nashville, Tennessee, United States, 37212
        • Ironwood Investigational Site
    • Utah
      • Logan, Utah, United States, 84341
        • Ironwood Investigational Site
      • South Ogden, Utah, United States, 84405
        • Ironwood Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IW-3718
Twice a day
Drug: IW-3718
Placebo Comparator: Matching Placebo
Twice a day
Drug: Matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Exploratory Endpoints - GERD Symptoms
Time Frame: Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period
Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ironwood Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

December 19, 2013

First Submitted That Met QC Criteria

January 8, 2014

First Posted (Estimate)

January 9, 2014

Study Record Updates

Last Update Posted (Estimate)

August 1, 2016

Last Update Submitted That Met QC Criteria

July 28, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICP-3718-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gastroesophageal Reflux

Clinical Trials on Matching Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Pakistan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe