Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis

NCT02025725 ↗

Phase 3 Completed 205 enrolled Evoke Pharma

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is provide confirmation of the safety and efficacy of Metoclopramide Nasal Spray compared to placebo in reducing the symptoms of diabetic gastroparesis in adult women.

Timeline

Start: 2014-03-27
Primary completion: 2016-05-27
Completion: 2016-06-27

Outcome

Missed primary endpoint

registry analysis (superiority test); 10 mg Metoclopramide Nasal Spray vs Placebo Nasal Spray; p = 0.881; ANCOVA NCT02025725 ↗

paper Although the primary end point was not met using all enrolled patients PMID 37924856 ↗

Publications

McCallum RW, Parkman HP, Fass R, Bhandari BR, Carlson MR, Buck RD. Metoclopramide Nasal Spray in Women With Symptomatic Diabetic Gastroparesis: A Randomized, Double-Blind, Placebo-Controlled Phase 3 Study. Clin Gastroenterol Hepatol. 2024 Dec;22(12):2497-2505.e5. doi: 10.1016/j.cgh.2023.10.022. Epub 2023 Nov 2.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Metoclopramide	Small molecule	10 mg	Intranasal