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

Ironwood Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Gastroesophageal Reflux Disease (GERD)

Treatments: Drug: placebo; Drug: IW-3718; Drug: Standard-dose PPIs QD

Study type: Interventional

Funder types: Industry

Identifiers

NCT03561090

C3718-301

Details and patient eligibility

About

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.

Enrollment: 495 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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.

Exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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495 participants in 2 patient groups, including a placebo group

1500 mg IW-3718 BID + PPI

Experimental group

Description:

Three 500 mg IW-3718 tablets administered twice daily (BID), immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.

Treatment:

Drug: IW-3718

Drug: Standard-dose PPIs QD

Placebo + PPI

Placebo Comparator group

Description:

Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day.

Treatment:

Drug: Standard-dose PPIs QD

Drug: placebo