Overview

A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)

Status:
Completed
Trial end date:
2017-04-26
Target enrollment:
0
Participant gender:
All
Summary
The objectives of this study are to evaluate the safety, efficacy, and dose-response relationship of IW-3718 administered orally to participants who have GERD and continue to experience GERD symptoms while receiving once-daily (QD), standard-dose proton pump inhibitors (PPIs).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Ironwood Pharmaceuticals, Inc.
Criteria
Inclusion Criteria:

- Patient is an ambulatory, community-dwelling male or nonpregnant female and is at
least 18 years old at the Screening Visit. Lactating females must agree not to
breastfeed.

- Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or
regurgitation) on ≥ 4 days per week during the 8 weeks before the Screening Visit
while taking standard QD PPI therapy.

Exclusion Criteria:

- Patient may not meet any of the excluded conditions specified in the protocol

- Patient has any alarm symptoms including but not limited to GI bleeding, anemia,
vomiting, dysphagia, or unexpected weight loss any time during the Screening or
Pretreatment Periods

- Patient has a history of clinically significant hypersensitivity or allergies to any
of the excipients contained in the study medication (active or placebo).

NOTE: Additional inclusion/exclusion criteria may apply.