A Study of of IW-3718 in Patients with Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors

Overview

About this study

The purpose of this study is to evaluate the safety and effectiveness 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 proton pump inhibitors (PPIs).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • 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 proton pump inhibitor (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.

Exclusion Criteria:

  • 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, 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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

La Crosse, Wis.

Mayo Clinic principal investigator

Genci Babameto, M.D.

Open for enrollment

Contact information:

Jodi Kaseno

(608)392-7187

Kaseno.Jodi@mayo.edu

Jacksonville, Fla.

Mayo Clinic principal investigator

Kenneth DeVault, M.D.

Open for enrollment

Contact information:

Frances Cayer CCRP

(904)953-7778

Cayer.Frances@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20461632

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