Trial · NCT02025751
Multicenter Study to Evaluate the Efficacy and Safety of Metoclopramide Nasal Spray in Men With Diabetic Gastroparesis
NCT02025751, Phase 3, Completed, Evoke Pharma; results first posted 2020-07-07
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 Men With Diabetic Gastroparesis. Trials, record NCT02025751. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02025751
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 Men With Diabetic Gastroparesis
- NCT number
- NCT02025751
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 53 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
- 2020-07-07
- Limitations and caveats
Study failed to meet recruitment goals (N=150) and was completed after 24 months (N=53). All study visits and assessments were completed. Limited pharmacokinetic (PK) samples so no calculated PK parameters.
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 | Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population) | 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
Outcomes1
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 | Change from the Baseline Period to Week 4 in Daily Total Score (Intent-to Treat Population) | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group2
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 | Metoclopramide Nasal Spray | -0.751 | Standard Deviation 0.4673 | score on a scale | |
| Gastroparesis Symptom Assessment (GSA), a Patient Reported Outcome Measure | Placebo Nasal Spray | -0.657 | Standard Deviation 0.9042 | score on a scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metoclopramide Nasal Spray | 26 | |
| Overall Study | STARTED | Placebo Nasal Spray | 27 | |
| Overall Study | COMPLETED | Metoclopramide Nasal Spray | 25 | |
| Overall Study | COMPLETED | Placebo Nasal Spray | 24 | |
| Overall Study | NOT COMPLETED | Metoclopramide Nasal Spray | 1 | |
| Overall Study | NOT COMPLETED | Placebo Nasal Spray | 3 |
Source ClinicalTrials.gov
Adverse events56
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 | Liver palpable | Investigations | Metoclopramide Nasal Spray | 0 | 26 | 0 |
| other | Liver palpable | Investigations | Placebo Nasal Spray | 1 | 27 | 1 |
| other | Platelet count decreased | Investigations | Metoclopramide Nasal Spray | 1 | 26 | 1 |
| other | Platelet count decreased | Investigations | Placebo Nasal Spray | 0 | 27 | 0 |
| other | Malaise | General disorders | Metoclopramide Nasal Spray | 0 | 26 | 0 |
| other | Malaise | General disorders | Placebo Nasal Spray | 1 | 27 | 1 |
| other | Pyrexia | General disorders | Metoclopramide Nasal Spray | 0 | 26 | 0 |
| other | Pyrexia | General disorders | Placebo Nasal Spray | 1 | 27 | 1 |
| other | Ligament sprain | Injury, poisoning and procedural complications | Metoclopramide Nasal Spray | 1 | 26 | 1 |
| other | Ligament sprain | Injury, poisoning and procedural complications | Placebo Nasal Spray | 0 | 27 | 0 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metoclopramide Nasal Spray | 0 | 26 |
| Total, all-cause mortality | Placebo Nasal Spray | 0 | 27 |
| Total, other adverse events | Metoclopramide Nasal Spray | 7 | 26 |
| Total, other adverse events | Placebo Nasal Spray | 3 | 27 |
| Total, serious adverse events | Metoclopramide Nasal Spray | 0 | 26 |
| Total, serious adverse events | Placebo Nasal Spray | 3 | 27 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|---|
| Metoclopramide Nasal Spray vs Placebo Nasal Spray: deaths from any cause | Trial comparisons |
| 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.
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/NCT02025751
GET https://conductscience.org/api/trials/v1/NCT02025751/events?page=2