Trials / Completed
CompletedNCT03561883
Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs)
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Trial of Oral IW-3718 Administered to Patients With Gastroesophageal Reflux Disease While Receiving Proton Pump Inhibitors
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 609 (actual)
- Sponsor
- Ironwood Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the safety and efficacy of IW-3718 administered to patients with GERD who continue to have persistent symptoms, such as heartburn and regurgitation, while receiving once-daily (QD), standard dose PPIs.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | IW-3718 | oral tablet |
| DRUG | placebo | oral tablet |
| DRUG | Standard-dose PPIs QD | background therapy |
Timeline
- Start date
- 2018-09-06
- Primary completion
- 2020-07-28
- Completion
- 2020-11-06
- First posted
- 2018-06-19
- Last updated
- 2021-08-18
- Results posted
- 2021-08-18
Locations
101 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03561883. Inclusion in this directory is not an endorsement.