Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
IW-3718 · 3 trials · 3 indications
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.
The WHSS for an analysis week was defined as the average of available DHSS during that week. DHSS was defined as the maximum on a 6-point scale (0=Did Not Have, 1=Very Mild, 2=Mild, 3=Moderate, 4=Moderately Severe, 5=Severe) of the 3 items measuring heartburn ( "Heartburn," "Burning feeling behind breastbone or in the center of the upper stomach," and "Pain behind breastbone or in the center of the upper stomach,") from a particular day. 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. |
| Control | PLACEBO_COMPARATOR | Matching placebo twice daily |
| 500 mg IW-3718 | EXPERIMENTAL | 500 mg IW-3718 twice daily |
| 1000 mg IW-3718 | EXPERIMENTAL | 1000 mg IW-3718 twice daily |
| 1500 mg IW-3718 | EXPERIMENTAL | 1500 mg IW-3718 twice daily |
| IW-3718 | EXPERIMENTAL | Twice a day |
| Matching Placebo | PLACEBO_COMPARATOR | Twice a day |
| Name | Type | Description |
|---|---|---|
| IW-3718 | DRUG | oral tablet |
| placebo | DRUG | oral tablet |
| Standard-dose PPIs QD | DRUG | background therapy |
| Matching Placebo | DRUG | - |
| PPI | DRUG | 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. |
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...