Trial · NCT00845858
Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis
NCT00845858, Phase 2, Completed, Evoke Pharma; results first posted 2014-06-17
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis. Trials, record NCT00845858. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00845858
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Metoclopramide Nasal Spray Solution in Diabetic Patients With Gastroparesis
- NCT number
- NCT00845858
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 287 participants, actual
- Lead sponsor
- Evoke Pharma
- Conditions
- Gastroparesis, Diabetic Gastroparesis, Diabetes, Diabetes Mellitus, Delayed Gastric Emptying
- Interventions
- metoclopramide, Placebo
- First posted
- 2009-02-18
- Last updated
- 2014-06-27
- Results first posted
- 2014-06-17
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Other | The Pre-specified 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 by Gender. | 4 weeks | Change from Baseline to Week 4 of the treatment period in the mGCSI-DD total score in Female subjects receiving metoclopramide nasal spray versus Female 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. |
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 | 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 | ITT | units on a scale | MEAN |
| OTHER_PRE_SPECIFIED | The Pre-specified 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 by Gender. | 4 weeks | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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. | Metoclopramide Nasal Spray 10 mg | -1.2 | Standard Deviation 1.18 | units on a scale | |
| 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. | Metoclopramide Nasal Spray 14 mg | -1.2 | Standard Deviation 0.94 | units on a scale | |
| 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. | Placebo Nasal Spray | -1.0 | Standard Deviation 0.89 | units on a scale | |
| The Pre-specified 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 by Gender. | Female-Metoclopramide Nasal Spray 10 mg | -1.2 | Standard Deviation 1.18 | units on a scale | |
| The Pre-specified 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 by Gender. | Female-Metoclopramide Nasal Spray 14 mg | -1.3 | Standard Deviation 0.98 | units on a scale | |
| The Pre-specified 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 by Gender. | Female-Placebo Nasal Spray | -0.8 | Standard Deviation 0.79 | units on a scale |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metoclopramide Nasal Spray 10 mg | 96 | |
| Overall Study | STARTED | Metoclopramide Nasal Spray 14 mg | 96 | |
| Overall Study | STARTED | Placebo Nasal Spray | 95 | |
| Overall Study | COMPLETED | Metoclopramide Nasal Spray 10 mg | 88 | |
| Overall Study | COMPLETED | Metoclopramide Nasal Spray 14 mg | 84 | |
| Overall Study | COMPLETED | Placebo Nasal Spray | 87 | |
| Overall Study | NOT COMPLETED | Metoclopramide Nasal Spray 10 mg | 8 | |
| Overall Study | NOT COMPLETED | Metoclopramide Nasal Spray 14 mg | 12 | |
| Overall Study | NOT COMPLETED | Placebo Nasal Spray | 8 |
Source ClinicalTrials.gov
Adverse events150
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 | Dysguesia | Nervous system disorders | Metoclopramide Nasal Spray 10 mg | 12 | 95 | 13 |
| other | Dysguesia | Nervous system disorders | Metoclopramide Nasal Spray 14 mg | 13 | 95 | 14 |
| other | Dysguesia | Nervous system disorders | Placebo Nasal Spray | 4 | 95 | 4 |
| other | Headache | Nervous system disorders | Metoclopramide Nasal Spray 10 mg | 12 | 95 | 13 |
| other | Headache | Nervous system disorders | Metoclopramide Nasal Spray 14 mg | 13 | 95 | 14 |
| other | Headache | Nervous system disorders | Placebo Nasal Spray | 11 | 95 | 13 |
| other | Dizziness | Nervous system disorders | Metoclopramide Nasal Spray 10 mg | 3 | 95 | 3 |
| other | Dizziness | Nervous system disorders | Metoclopramide Nasal Spray 14 mg | 3 | 95 | 3 |
| other | Dizziness | Nervous system disorders | Placebo Nasal Spray | 2 | 95 | 2 |
| other | Somnolence | Nervous system disorders | Metoclopramide Nasal Spray 10 mg | 2 | 95 | 2 |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metoclopramide Nasal Spray 10 mg | ||
| Total, all-cause mortality | Metoclopramide Nasal Spray 14 mg | ||
| Total, all-cause mortality | Placebo Nasal Spray | ||
| Total, other adverse events | Metoclopramide Nasal Spray 10 mg | 53 | 95 |
| Total, other adverse events | Metoclopramide Nasal Spray 14 mg | 57 | 95 |
| Total, other adverse events | Placebo Nasal Spray | 53 | 95 |
| Total, serious adverse events | Metoclopramide Nasal Spray 10 mg | 0 | 95 |
| Total, serious adverse events | Metoclopramide Nasal Spray 14 mg | 2 | 95 |
| Total, serious adverse events | Placebo Nasal Spray | 3 | 95 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25576687 | 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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT00845858
GET https://conductscience.org/api/trials/v1/NCT00845858/events?page=2