Trial · NCT02025725

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

NCT02025725, Phase 3, Completed, Evoke Pharma; results first posted 2020-02-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis. Trials, record NCT02025725. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02025725

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Women With Diabetic Gastroparesis
NCT number: NCT02025725
Status: Completed
Phases: Phase 3
Enrollment: 205 participants, actual
Lead sponsor: Evoke Pharma
Conditions: Diabetic Gastroparesis
Interventions: Metoclopramide Nasal Spray, Placebo Nasal Spray
First posted: 2014-01-01
Last updated: 2020-07-07
Results first posted: 2020-02-11

Source ClinicalTrials.gov

Registered outcomes1

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure	Baseline Period to Week 4 of the Treatment Period	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.

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure	Baseline Period to Week 4 of the Treatment Period	Intent-to-Treat (ITT) Population	score on a scale	MEAN
POST_HOC	Gastroparesis Symptom Assessment (GSA)	Baseline Period to Weeks 1, 2, 3 and 4 of the Treatment Period	Subjects in the intent-to-treat population with moderate to severe disease (symptoms) at Baseline (i.e., baseline GSA scores higher than 2.7 on the 0-4 scale). Results presented are Weeks 1, 2, 3 and 4 compared to the Baseline Period.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure	10 mg Metoclopramide Nasal Spray		-0.925	Standard Deviation 0.935	score on a scale
Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure	Placebo Nasal Spray		-0.896	Standard Deviation 0.947	score on a scale
Gastroparesis Symptom Assessment (GSA)	10 mg Metoclopramide Nasal Spray	Week 1 of Treatment compared to Baseline Period	-0.587	Standard Deviation 0.520	score on a scale
Gastroparesis Symptom Assessment (GSA)	Placebo Nasal Spray	Week 1 of Treatment compared to Baseline Period	-0.388	Standard Deviation 0.444	score on a scale
Gastroparesis Symptom Assessment (GSA)	10 mg Metoclopramide Nasal Spray	Week 2 of Treatment compared to Baseline Period	-0.949	Standard Deviation 0.864	score on a scale
Gastroparesis Symptom Assessment (GSA)	Placebo Nasal Spray	Week 2 of Treatment compared to Baseline Period	-0.616	Standard Deviation 0.635	score on a scale
Gastroparesis Symptom Assessment (GSA)	10 mg Metoclopramide Nasal Spray	Week 3 of Treatment compared to Baseline Period	-1.095	Standard Deviation 0.912	score on a scale
Gastroparesis Symptom Assessment (GSA)	Placebo Nasal Spray	Week 3 of Treatment compared to Baseline Period	-0.750	Standard Deviation 0.785	score on a scale
Gastroparesis Symptom Assessment (GSA)	10 mg Metoclopramide Nasal Spray	Week 4 of Treatment compared to Baseline Period	-1.218	Standard Deviation 0.991	score on a scale
Gastroparesis Symptom Assessment (GSA)	Placebo Nasal Spray	Week 4 of Treatment compared to Baseline Period	-0.857	Standard Deviation 0.938	score on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	10 mg Metoclopramide Nasal Spray	102
Overall Study	STARTED	Placebo Nasal Spray	103
Overall Study	COMPLETED	10 mg Metoclopramide Nasal Spray	91
Overall Study	COMPLETED	Placebo Nasal Spray	99
Overall Study	NOT COMPLETED	10 mg Metoclopramide Nasal Spray	11
Overall Study	NOT COMPLETED	Placebo Nasal Spray	4

Source ClinicalTrials.gov

Adverse events42

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Headache	Nervous system disorders	10 mg Metoclopramide Nasal Spray	5	102	6
other	Headache	Nervous system disorders	Placebo Nasal Spray	7	103	9
other	Abdominal pain	Gastrointestinal disorders	10 mg Metoclopramide Nasal Spray	1	102	1
other	Abdominal pain	Gastrointestinal disorders	Placebo Nasal Spray	5	103	5
other	Abdominal tenderness	Gastrointestinal disorders	10 mg Metoclopramide Nasal Spray	1	102	1
other	Abdominal tenderness	Gastrointestinal disorders	Placebo Nasal Spray	2	103	2
other	Constipation	Gastrointestinal disorders	10 mg Metoclopramide Nasal Spray	1	102	1
other	Constipation	Gastrointestinal disorders	Placebo Nasal Spray	2	103	2
other	Diarrhoea	Gastrointestinal disorders	10 mg Metoclopramide Nasal Spray	3	102	3
other	Diarrhoea	Gastrointestinal disorders	Placebo Nasal Spray	0	103	0

1 to 10 of 42Source ClinicalTrials.gov

See all 42 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	10 mg Metoclopramide Nasal Spray	0	102
Total, all-cause mortality	Placebo Nasal Spray	0	103
Total, other adverse events	10 mg Metoclopramide Nasal Spray	21	102
Total, other adverse events	Placebo Nasal Spray	36	103
Total, serious adverse events	10 mg Metoclopramide Nasal Spray	3	102
Total, serious adverse events	Placebo Nasal Spray	2	103

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
37924856	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
10 mg Metoclopramide Nasal Spray vs Placebo Nasal Spray: deaths from any cause	Trial comparisons
10 mg Metoclopramide Nasal Spray vs Placebo Nasal Spray: serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02025725

GET https://conductscience.org/api/trials/v1/NCT02025725/events?page=2

API reference For AI assistants