Ph2a Study to Evaluate IW-3718 in Patients With Gastroesophageal Reflux Not Completely Responsive to Proton Pump Inhibitors
- Registration Number
- NCT02030925
- Lead Sponsor
- Ironwood Pharmaceuticals, Inc.
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 93
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Matching Placebo Matching Placebo Twice a day IW-3718 IW-3718 Twice a day
- Primary Outcome Measures
Name Time Method Exploratory Endpoints - GERD Symptoms Change from baseline: Treatment Period (weeks 1-4) compared with 2-week (baseline) Pretreatment Period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Ironwood Investigational Site
🇺🇸South Ogden, Utah, United States