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

A Phase 2a Study to Evaluate the Effect of IW-3718 Administered Orally for 4 Weeks in Patients With GERD Not Completely Responsive to Proton Pump Inhibitors

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02030925

Enrollment

Registered

2014-01-09

Start date

2014-02-28

Completion date

2014-12-31

Last updated

2016-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastroesophageal Reflux

Brief summary

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).

Interventions

DRUGIW-3718

DRUGMatching Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Exploratory Endpoints - GERD Symptoms	Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 28, 2026