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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02267525 | The Diabetic and Idiopathic Gastroparesis Efficacy, Safety, and Tolerability (DIGEST) Study | PHASE2 | COMPLETED | 233 | — | — | Dec 1, 2014 | Jun 1, 2017 | Apr 17, 2018 | - | — |
| NCT01718938 | Phase 2 Study of Velusetrag in Diabetic or Idiopathic Gastroparesis | PHASE2 | COMPLETED | 34 | — | — | Dec 1, 2012 | Feb 1, 2014 | Feb 26, 2018 | 9 | United States |
| Arm | Type | Description |
|---|---|---|
| Velusetrag 5mg | EXPERIMENTAL | Velusetrag 5mg capsules QD (once daily) x 12 weeks |
| Velusetrag 15mg | EXPERIMENTAL | Velusetrag 15mg capsules QD x 12 weeks |
| Velusetrag 30mg | EXPERIMENTAL | Velusetrag 30mg capsules QD x 12 weeks |
| Placebo | PLACEBO_COMPARATOR | Placebo capsules QD x 12 weeks |
| Sequence 1 | EXPERIMENTAL | 3-way crossover of velusetrag or placebo |
| Sequence 2 | EXPERIMENTAL | 3-way crossover of velusetrag or placebo |
| Sequence 3 | EXPERIMENTAL | 3-way crossover of velusetrag or placebo |
| Sequence 4 | EXPERIMENTAL | 3-way crossover of velusetrag or placebo |
| Name | Type | Description |
|---|---|---|
| Velusetrag | DRUG | - |
| Placebo | DRUG | - |
| velusetrag dose 1 | DRUG | - |
| velusetrag dose 2 | DRUG | - |
| velusetrag dose 3 | DRUG | - |
Inclusion Criteria: * Symptoms of gastroparesis (eg, nausea, early satiety, fullness, bloating, upper abdominal pain, retching or vomiting) for at least 3 months prior to Screening * Composite score ≥2and \<5 on nausea, bloating, feeling excessively full after meals, and not able to finish a normal...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE4 | Tradipitant |
| United Therapeutics Corporation | UTHR | 1 | PHASE4 | Undisclosed |