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

Completed · Phase 2 · Has a placebo group

Conditions studied: Gastroesophageal Reflux

In brief

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).

Key facts

Study ID

NCT02030925

Run by

Ironwood Pharmaceuticals, Inc.

People needed

93

Starts

2014-02-01

Expected to finish

2014-12-01

Last updated by the study team

2016-08-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Ironwood Investigational Site — North Little Rock, Arkansas, United States
• Ironwood Investigational Site — Anaheim, California, United States
• Ironwood Investigational Site — Monroe, Louisiana, United States
• Ironwood Investigational Site — Chesterfield, Michigan, United States
• Ironwood Investigational Site — Raleigh, North Carolina, United States
• Ironwood Investigational Site — Cleveland, Ohio, United States
• Ironwood Investigational Site — Chattanooga, Tennessee, United States
• Ironwood Investigational Site — Nashville, Tennessee, United States
• Ironwood Investigational Site — Logan, Utah, United States
• Ironwood Investigational Site — South Ogden, Utah, United States

Full record on ClinicalTrials.gov

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