Trial · NCT00475306
The Montefiore Metoclopramide Study
NCT00475306, Phase 4, Completed, Montefiore Medical Center; results first posted 2012-12-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Montefiore Metoclopramide Study. Trials, record NCT00475306. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00475306
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Montefiore Metoclopramide Study
- NCT number
- NCT00475306
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 289 participants, actual
- Lead sponsor
- Montefiore Medical Center
- Conditions
- Nausea, Extrapyramidal Symptoms
- Interventions
- metoclopramide 10 mg, Diphenhydramine 25 mg, Placebo, Metoclopramide 20 mg
- First posted
- 2007-05-21
- Last updated
- 2012-12-31
- Results first posted
- 2012-12-31
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Nausea Scale | 60 minutes | Patients were asked to report their level of nausea on a scale for 0 to 10, with 0 representing no nausea and 10 the worst nausea imaginable |
| Secondary | Number of Participants With Akathisia | 60 minutes | The akathisia outcome was reported as follows: Either development of akathisia as measured using the Short Akathisia Instrument (Vinson DR. Journal of Emergency Medicine. 2006; 31:139-145)or use of rescue medication for treatment of akathisia.The short akathisia instrument briefly measures subjective and objective restlessness. |
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 | Nausea Scale | 60 minutes | Only patients who received the investigational medication are included in this analysis. Please see the participant flow section for more details. | units on a scale | MEDIAN |
| SECONDARY | Number of Participants With Akathisia | 60 minutes | Only patients who received the investigational medication are included in this analysis. Please see participant flow for details | participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Nausea Scale | Metoclopramide 20mg+Diphenhydramine | 0 | Inter-Quartile Range 0 to 2 | units on a scale | |
| Nausea Scale | Metoclopramide 20+Placebo | 0 | Inter-Quartile Range 0 to 2 | units on a scale | |
| Nausea Scale | Metoclopramide 10 + Placebo | 0 | Inter-Quartile Range 0 to 2 | units on a scale | |
| Nausea Scale | Metoclopramide 10+Diphenhydramine | 0 | Inter-Quartile Range 0 to 2 | units on a scale | |
| Number of Participants With Akathisia | Metoclopramide 20mg+Diphenhydramine | 9 | participants | ||
| Number of Participants With Akathisia | Metoclopramide 20+Placebo | 12 | participants | ||
| Number of Participants With Akathisia | Metoclopramide 10 + Placebo | 5 | participants | ||
| Number of Participants With Akathisia | Metoclopramide 10+Diphenhydramine | 8 | participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metoclopramide 20 mg+Diphenhydramine | 73 | |
| Overall Study | STARTED | Metoclopramide 20+Placebo | 72 | |
| Overall Study | STARTED | Metoclopramide 10 + Placebo | 72 | |
| Overall Study | STARTED | Metoclopramide 10+Diphenhydramine | 72 | |
| Overall Study | COMPLETED | Metoclopramide 20 mg+Diphenhydramine | 72 | |
| Overall Study | COMPLETED | Metoclopramide 20+Placebo | 71 | |
| Overall Study | COMPLETED | Metoclopramide 10 + Placebo | 72 | |
| Overall Study | COMPLETED | Metoclopramide 10+Diphenhydramine | 71 | |
| Overall Study | NOT COMPLETED | Metoclopramide 20 mg+Diphenhydramine | 1 | |
| Overall Study | NOT COMPLETED | Metoclopramide 20+Placebo | 1 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metoclopramide 20mg+Diphenhydramine | ||
| Total, all-cause mortality | Metoclopramide 20+Placebo | ||
| Total, all-cause mortality | Metoclopramide 10 + Placebo | ||
| Total, all-cause mortality | Metoclopramide 10+Diphenhydramine | ||
| Total, other adverse events | Metoclopramide 20mg+Diphenhydramine | 0 | 72 |
| Total, other adverse events | Metoclopramide 20+Placebo | 0 | 71 |
| Total, other adverse events | Metoclopramide 10 + Placebo | 0 | 72 |
| Total, other adverse events | Metoclopramide 10+Diphenhydramine | 0 | 71 |
| Total, serious adverse events | Metoclopramide 20mg+Diphenhydramine | 0 | 72 |
| Total, serious adverse events | Metoclopramide 20+Placebo | 0 | 71 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 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/NCT00475306
GET https://conductscience.org/api/trials/v1/NCT00475306/registered