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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02025751 | Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis | PHASE3 | COMPLETED | 53 | — | — | Apr 1, 2014 | Oct 1, 2016 | Jul 7, 2020 | 49 | United States |
| NCT02025725 | Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis | PHASE3 | COMPLETED | 205 | — | — | Mar 27, 2014 | Jun 27, 2016 | Jul 7, 2020 | 50 | United States |
Change from the Baseline Period to Week 4 of the Treatment Period in the mean daily Gastroparesis Symptom Assessment (GSA) total score for subjects receiving Metoclopramide Nasal Spray 10 mg versus subjects receiving placebo. The GSA minimum value is 0 (no symptoms) and the maximum value is 4 (very severe symptoms). A higher score is a worse outcome.
| Arm | Type | Description |
|---|---|---|
| Metoclopramide Nasal Spray | EXPERIMENTAL | Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks |
| Placebo Nasal Spray | PLACEBO_COMPARATOR | Placebo Nasal Spray 30 minutes before meals and at bedtime (QID) for 4 weeks |
| 10 mg Metoclopramide Nasal Spray | EXPERIMENTAL | Metoclopramide Nasal Spray 10 mg, 30 minutes before meals and at bedtime (QID) for 4 weeks |
| Name | Type | Description |
|---|---|---|
| Metoclopramide Nasal Spray | DRUG | One 10 mg spray dose 30 minutes before meals and before bed for 28 days (QID) |
| Placebo Nasal Spray | DRUG | One placebo spray dose 30 minutes before meals and before bed for 28 days (QID) |
Inclusion Criteria: * Male subjects between the ages of 18 and 75 years * Willingness and ability to give written informed consent * The ability to read, understand and speak English * Prior diagnosis of Type 1 or Type 2 diabetes * Diagnosis of diabetic gastroparesis with confirmation of delayed ga...