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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

93 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2014-12-31

Brief Summary

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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).

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Detailed Description

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Conditions

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Gastroesophageal Reflux

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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IW-3718

Twice a day

Group Type EXPERIMENTAL

IW-3718

Intervention Type DRUG

Matching Placebo

Twice a day

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Interventions

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IW-3718

Intervention Type DRUG

Matching Placebo

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No