Phase IIb multicentre, randomised, open-label, parallel study to compare the efficacy and safety of metoclopramide nasal spray to oral tablets in patients with diabetic gastroparesis
Phase of Trial: Phase II
Latest Information Update: 15 Feb 2018
At a glance
- Drugs Metoclopramide (Primary) ; Metoclopramide (Primary)
- Indications Diabetic gastroparesis
- Focus Therapeutic Use
- 15 Feb 2018 According to an Evoke Pharma media release, the company plans to submit its NDA for a female-only indication based on a dose in women with equivalent exposure to Reglan Tablets and will submit supporting efficacy and safety data from this and other trial (see profile 282791) specifically for women, at doses similar or lower than the dose to be proposed in the NDA. The Company expects to file the Gimoti NDA in the second quarter of 2018.
- 04 Mar 2014 Results will be presented at the 26th Annual ROTH Conference according to an Evoke Pharma media release.
- 07 Feb 2014 New trial record