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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02210000 | A Study to Evaluate the Effect of Camicinal on Gastroparesis Symptoms in Type 1 and 2 Diabetic Subjects With Gastroparesis | PHASE2 | COMPLETED | 114 | — | — | Aug 27, 2014 | Aug 24, 2015 | Dec 11, 2017 | 34 | United States |
The GCSI-DD consists of nine symptom severity items covering the following domains: nausea/vomiting; fullness/early satiety, and bloating. In addition, the GCSI-DD contains two symptom severity items upper abdominal pain and overall rating of gastroparesis symptoms. Participants were asked to rate each symptom on a 6-point scale from 0 to 5 with lower scores representing less symptom severity and higher scores indicating more severe symptoms. Fullness/early satiety response is defined as an improvement from Baseline by at least one point in the weekly average for the subscale. A participant was defined as a responder if the participant's weekly average change from Baseline in the fullness/early satiety response score improved by at least 1 point. Percentage of participants showing response were presented.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Subjects will receive camicinal matching placebo orally once daily (QD) from Day 1 to Day 84 |
| Camicinal 25mg | EXPERIMENTAL | Subjects will receive camicinal 25 mg orally QD from Day 1 to Day 84 |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Camicinal matching placebo is available as tablet to be taken orally with 100mL of water in the morning |
| Camicinal | DRUG | Camicinal is available as 25 mg tablet to be taken orally with 100mL of water in the morning |
Inclusion Criteria: * Type 1 or 2 diabetes mellitus (acetylated hemoglobin A1 \[HbA1c\] \<=11.0%) * Male or female between 18 and 80 years of age, inclusive. * Patient has gastroparesis at screening. A patient is eligible if one of the following criteria are met: Gastric half-time of emptying \>upp...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | VNDA | 1 | PHASE4 | Tradipitant |
| United Therapeutics Corporation | UTHR | 1 | PHASE4 | Undisclosed |