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

Ironwood Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Gastroesophageal Reflux

Treatments: Drug: Matching Placebo; Drug: IW-3718

Study type: Interventional

Funder types: Industry

Identifiers

NCT02030925

ICP-3718-201

Details and patient eligibility

About

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).

Enrollment: 93 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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93 participants in 2 patient groups, including a placebo group

IW-3718

Experimental group

Description:

Twice a day

Treatment:

Drug: IW-3718

Matching Placebo

Placebo Comparator group

Description:

Twice a day

Treatment:

Drug: Matching Placebo