Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Metoclopramide · 3 trials · 5 indications
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.
Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in male and female subjects receiving metoclopramide nasal spray versus subjects receiving placebo. The mGCSI-DD is a patient reported outcome measure of gastroparesis symptom severity composed of 4 individual symptoms (listed below) with each symptom graded on a scale from 0 (none) to 5 (very severe). 1. Nausea (feeling sick to your stomach as if you were going to vomit or throw up) 2. Early satiety (not able to finish a normal sized meal) 3. Bloating (feeling like you need to loosen clothes) 4. Upper abdominal pain (above the navel) The mGCSI-DD daily score is a mean of the 4 individual symptom scores. The total score is a mean of the daily scores for the observation period. A mean change (improvement) of \>1 category (for example, moderate to mild or severe to moderate) is considered to be clinically meaningful.
| 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 |
| Metoclopramide Nasal Spray 10 mg | ACTIVE_COMPARATOR | - |
| Metoclopramide Nasal Spray 14 mg | ACTIVE_COMPARATOR | - |
| 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) |
| metoclopramide | DRUG | 30 minutes before meals and at bedtime for 4 weeks |
| Placebo | DRUG | 30 minutes before meals and at bedtime |
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...