Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis

Phase 2

Completed

• Conditions: Gastroparesis; Diabetic Gastroparesis; Diabetes; Diabetes Mellitus; Delayed Gastric Emptying
• Interventions: Drug: Placebo; Drug: metoclopramide

• Registration Number: NCT00845858
• Lead Sponsor: Evoke Pharma

Brief Summary

To evaluate the safety and the effectiveness of two doses of metoclopramide nasal spray solution, 10 mg and 14 mg, compared to placebo in reducing the symptoms of diabetic gastroparesis.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-02-17
• Study First Submitted QC: 2009-02-17
• Study First Posted: 2009-02-18
• Study Start: 2009-04
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2013-11
• Results First Submitted: 2014-04-17
• Results First Submitted QC: 2014-05-16
• Results First Posted: 2014-06-17
• Last Update Submitted: 2014-06-17
• Last Update Posted: 2014-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 287

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Nasal Spray	Placebo	-
Metoclopramide Nasal Spray 10 mg	metoclopramide	-
Metoclopramide Nasal Spray 14 mg	metoclopramide	-

Primary Outcome Measures

Name	Time	Method
The Primary Efficacy Endpoint is the Change From Baseline to Week 4 of the Treatment Period in the Modified Gastroparesis Cardinal Symptom Index-Daily Diary (mGCSI-DD) Total Score.	4 weeks	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.

Trial Locations

Locations (65)

Digestive Specialists of the Southeast; 🇺🇸 Dothan, Alabama, United States

Clinical Research Associates; 🇺🇸 Huntsville, Alabama, United States

Medical Affiliated Research Center, Inc.; 🇺🇸 Huntsville, Alabama, United States

Desert Sun Gastroenterology; 🇺🇸 Tucson, Arizona, United States

Clopton Clinic; 🇺🇸 Jonesboro, Arkansas, United States

Arkansas Gastroenterology; 🇺🇸 Sherwood, Arkansas, United States

Robert M. Karns, MD, a Medical Corporation; 🇺🇸 Beverly Hills, California, United States

VA Long Beach Healthcare System; 🇺🇸 Long Beach, California, United States

Impact Clinical Trials; 🇺🇸 Los Angeles, California, United States

Prime-Care Clinical Research; 🇺🇸 Mission Viejo, California, United States

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