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

Completed · 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

NCT03561883

Run by

Ironwood Pharmaceuticals, Inc.

People needed

609

Starts

2018-09-06

Expected to finish

2020-11-06

Last updated by the study team

2021-08-18

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

• Digestive Health Specialists of The Southeast — Dothan, Alabama, United States
• Holland Center for Family Health — Peoria, Arizona, United States
• Hope Research Institute LLC — Peoria, Arizona, United States
• Atria Clinical Research — Little Rock, Arkansas, United States
• Preferred Research Partners — Little Rock, Arkansas, United States
• Hope Clinical Research, LLC — Canoga Park, California, United States
• Om Research LLC — Lancaster, California, United States
• Torrance Clinical Research — Lomita, California, United States
• United Gastroenterologists — Murrieta, California, United States
• Clinical Applications Laboratories Inc — San Diego, California, United States
• Care Access Research, San Pablo — San Pablo, California, United States
• Paragon Rx Clinical, Inc. - Santa Ana — Santa Ana, California, United States
• Medical Research Center of Connecticut LLC — Hamden, Connecticut, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Stamford Therapeutics Consortium — Stamford, Connecticut, United States
• Optimus U Corp — Coral Gables, Florida, United States
• Nature Coast Clinical Research LLC - ERN-PPDS — Inverness, Florida, United States
• Jacksonville Center For Clinical Research — Jacksonville, Florida, United States
• Precision Clinical Research, LLC — Lauderdale Lakes, Florida, United States
• Suncoast Research Group LLC - ERN-PPDS — Miami, Florida, United States
• Applemed Research Inc — Miami, Florida, United States
• Gutierrez Medical Center — Orlando, Florida, United States
• Columbus Regional Research Institute at Talbotton — Columbus, Georgia, United States
• Consultative Gastroenterology — Decatur, Georgia, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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