A Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Gastroesophageal Reflux Disease (GERD)

In brief

The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard-dose PPIs.

Key facts

Study ID

NCT03561090

Run by

Ironwood Pharmaceuticals, Inc.

People needed

495

Starts

2018-06-20

Expected to finish

2020-11-03

Last updated by the study team

2021-08-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Each patient must meet all of the following criteria to be eligible for enrollment in this study:
• Patient is an ambulatory male or female (if female, nonpregnant) and is at least 18 years old at the Screening Visit.
• Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or regurgitation) while taking standard PPI therapy.
• Patient has evidence of pathological acid reflux.
• Female patients must not be pregnant and must agree to avoid pregnancy for the duration of the study.
• Patient must comply with study procedures.

You may not qualify if…

• Patients who meet any of the following criteria will not be eligible to participate in the study:
• Patient has a history of complete lack of GERD symptom response to PPI therapy.
• Patient has a significant medical or surgical history including conditions that would impact drug absorption or metabolism (such as bowel obstruction, poorly controlled diabetes, gastroparesis, hiatal hernia).
• Patient reports pain or burning behind the breastbone or in the center of the upper stomach as his or her predominant symptom at the Screening Visit.
• Patient has received an investigational drug during the 30 days before the Screening Visit, or is planning to receive another investigational drug or use an investigational device at any time during the study.
• NOTE: Other inclusion and exclusion criteria apply, per the study protocol.

Where it is running

• Alabama Medical Group, PC — Mobile, Alabama, United States
• Elite Clinical Studies — Phoenix, Arizona, United States
• Adobe Clinical Research LLC — Tucson, Arizona, United States
• Applied Research Center — Little Rock, Arkansas, United States
• Arkansas Gastroenterology — North Little Rock, Arkansas, United States
• Anaheim Clinical Trials LLC - ERN-PPDS — Anaheim, California, United States
• GW Research, Inc. — Chula Vista, California, United States
• Kindred Medical Institute for Clinical Trials, LLC — Corona, California, United States
• Facey Medical Foundation — Mission Hills, California, United States
• Northern California Research Corp — Sacramento, California, United States
• Digestive Care Center — San Carlos, California, United States
• Precision Research Institute — San Diego, California, United States
• Medical Associates Research Group, Inc. — San Diego, California, United States
• Stanford University School of Medicine — Stanford, California, United States
• University of Colorado Hospital — Aurora, Colorado, United States
• Gastroenterology Associates of Fairfield County — Bridgeport, Connecticut, United States
• Connecticut Clinical Research Foundation — Bristol, Connecticut, United States
• Chase Medical Research LLC — Waterbury, Connecticut, United States
• West Central Gastroenterology, LLP — Clearwater, Florida, United States
• Avail Clinical Research LLC — DeLand, Florida, United States
• University of Florida — Gainesville, Florida, United States
• Mayo Clinic Jacksonville - PPDS — Jacksonville, Florida, United States
• Borland Groover Clinic — Jacksonville, Florida, United States
• Health Awareness Inc - MRA — Jupiter, Florida, United States
• Pinnacle Research Group — Anniston, Alabama, United States

Full record on ClinicalTrials.gov

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