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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00838396 | A Study to Evaluate the Efficacy and Safety of Controlled Release Arbaclofen Placarbil (XP19986) in Patients With Gastroesophageal Reflux Disease | PHASE2 | COMPLETED | 58 | — | — | Oct 1, 2005 | Aug 1, 2006 | Sep 14, 2016 | 3 | United States |
| Arm | Type | Description |
|---|---|---|
| XP19986 CR | EXPERIMENTAL | On either study Day 1 or study Day 5 (after completion of the minimum 3-day washout period), participants received a single dose of XP19986 10, 20, 40 or 60 mg. |
| Placebo for XP19986 CR | PLACEBO_COMPARATOR | On either study Day 1 or study Day 5 (after completion of the minimum 3-day washout period), participants received a single dose of placebo. |
| Name | Type | Description |
|---|---|---|
| XP19986 CR | DRUG | - |
| Placebo for XP19986 CR | DRUG | - |
Inclusion Criteria: 1. History of GERD symptoms (e.g. heartburn episodes) at least 3 times per week 2. Discontinuation of drugs used to treat GERD (PPIs, H2-blockers) and/or drugs known to cause GERD symptoms (e.g. nonsteroidal anti-inflammatory drugs \[NSAIDs\]) for 7 days prior to baseline (Visit...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| AstraZeneca PLC | AZN | 1 | PHASE3 | Nexium |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 1 | PHASE2 | Dexlansoprazole |
| Catalyst Pharmaceuticals, Inc. | CPRX | 1 | PHASE2 | MHS-1031 |
| Phathom Pharmaceuticals, Inc. | PHAT | 1 | — | Vonoprazan |