Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT03561883 | Trial of IW-3718 for 8 Weeks in Patients With Persistent Gastroesophageal Reflux Disease (GERD) Receiving Proton Pump Inhibitors (PPIs) | PHASE3 | COMPLETED | 609 | — | — | Sep 6, 2018 | Nov 6, 2020 | Aug 18, 2021 | 101 | United States, Canada |
The WHSS is defined as the weekly average of the DHSS. The DHSS for a day is the greater of the 2 items assessing heartburn severity (Item #1 "Burning feeling behind the breastbone or in the center of the upper stomach" and Item #2 "Pain behind the breastbone or in the center of the upper stomach"). The DHSS items are assessed on a 5-point ordinal scale, where 0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, and 5=Severe; higher scores indicate worse symptoms. A negative change from baseline indicates improvement.
| Arm | Type | Description |
|---|---|---|
| 1500 mg IW-3718 BID | EXPERIMENTAL | Three 500 mg IW-3718 tablets administered twice daily (BID), immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day. |
| Placebo | PLACEBO_COMPARATOR | Three placebo tablets administered BID immediately after the morning and evening meals. Standard-dose PPIs administered QD approximately 30-60 minutes before the morning meal each day. |
| Name | Type | Description |
|---|---|---|
| IW-3718 | DRUG | oral tablet |
| placebo | DRUG | oral tablet |
| Standard-dose PPIs QD | DRUG | background therapy |
Inclusion Criteria: Each patient must meet all of the following criteria to be eligible for enrollment in this study: * Patient is an ambulatory male or female (if female, nonpregnant) and is at least 18 years old at the Screening Visit. * Patient has a diagnosis of GERD and reports experiencing G...