Trials / Completed
CompletedNCT02637557
A Trial of IW-3718 for 8 Weeks in Patients With Symptomatic Gastroesophageal Reflux Disease (GERD)
A Phase 2b, Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose-range-finding Trial of IW-3718 Administered Orally for 8 Weeks to Patients With Symptomatic Gastroesophageal Reflux Disease Not Completely Responsive to Proton Pump Inhibitors
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 282 (actual)
- Sponsor
- Ironwood Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IW-3718 | |
| DRUG | Matching Placebo | |
| DRUG | PPI | All participants were taking a standard dose QD PPI (dexlansoprazole, esomeprazole, esomeprazole magnesium, lansoprazole, omeprazole, pantoprazole, pantoprazole sodium sesquihydrate, rabeprazole or rabeprazole sodium) during the study. |
Timeline
- Start date
- 2016-03-01
- Primary completion
- 2017-04-26
- Completion
- 2017-04-26
- First posted
- 2015-12-22
- Last updated
- 2019-10-15
- Results posted
- 2019-10-15
Locations
62 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02637557. Inclusion in this directory is not an endorsement.