Trial Outcomes & Findings for The Montefiore Metoclopramide Study (NCT NCT00475306)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

289 participants

Primary outcome timeframe

60 minutes

Results posted on

2012-12-31

Participant Flow

Patients who presented to one ED with nausea were eligible for participation

Participant milestones

Participant milestones
Measure	Metoclopramide 20 mg+Diphenhydramine Metoclopramide 20mg co-administered with diphenhydramine 25 mg, intravenously	Metoclopramide 20+Placebo Metoclopramide 20 mg co-administered with placebo, intravenously	Metoclopramide 10 + Placebo Metoclopramide 10 mg co-administered with placebo, intravenously	Metoclopramide 10+Diphenhydramine Metoclopramide 10 mg co-administered with diphenhydramine 25 mg, intravenously
Overall Study STARTED	73	72	72	72
Overall Study COMPLETED	72	71	72	71
Overall Study NOT COMPLETED	1	1	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Metoclopramide 20 mg+Diphenhydramine Metoclopramide 20mg co-administered with diphenhydramine 25 mg, intravenously	Metoclopramide 20+Placebo Metoclopramide 20 mg co-administered with placebo, intravenously	Metoclopramide 10 + Placebo Metoclopramide 10 mg co-administered with placebo, intravenously	Metoclopramide 10+Diphenhydramine Metoclopramide 10 mg co-administered with diphenhydramine 25 mg, intravenously
Overall Study Protocol Violation	1	1	0	1

Baseline Characteristics

The Montefiore Metoclopramide Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Metoclopramide 20mg+Diphenhydramine n=72 Participants Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously	Metoclopramide 20+Placebo n=71 Participants Metoclopramide 20 mg co-administered with placebo, intravenously	Metoclopramide 10 + Placebo n=72 Participants Metoclopramide 10 mg co-administered with placebo, intravenously	Metoclopramide 10+Diphenhydramine n=71 Participants Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously	Total n=286 Participants Total of all reporting groups
Age Continuous	39 Years STANDARD_DEVIATION 12 • n=5 Participants	42 Years STANDARD_DEVIATION 14 • n=7 Participants	40 Years STANDARD_DEVIATION 13 • n=5 Participants	39 Years STANDARD_DEVIATION 13 • n=4 Participants	40 Years STANDARD_DEVIATION 13 • n=21 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	52 Participants n=7 Participants	55 Participants n=5 Participants	51 Participants n=4 Participants	210 Participants n=21 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	19 Participants n=7 Participants	17 Participants n=5 Participants	20 Participants n=4 Participants	76 Participants n=21 Participants

PRIMARY outcome

Timeframe: 60 minutes

Population: Only patients who received the investigational medication are included in this analysis. Please see the participant flow section for more details.

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

Outcome measures

Outcome measures
Measure	Metoclopramide 20mg+Diphenhydramine n=72 Participants Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously	Metoclopramide 20+Placebo n=71 Participants Metoclopramide 20 mg co-administered with placebo, intravenously	Metoclopramide 10 + Placebo n=72 Participants Metoclopramide 10 mg co-administered with placebo, intravenously	Metoclopramide 10+Diphenhydramine n=71 Participants Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
Nausea Scale	0 units on a scale Interval 0.0 to 2.0	0 units on a scale Interval 0.0 to 2.0	0 units on a scale Interval 0.0 to 2.0	0 units on a scale Interval 0.0 to 2.0

SECONDARY outcome

Timeframe: 60 minutes

Population: Only patients who received the investigational medication are included in this analysis. Please see participant flow for details

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.

Outcome measures

Outcome measures
Measure	Metoclopramide 20mg+Diphenhydramine n=72 Participants Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously	Metoclopramide 20+Placebo n=71 Participants Metoclopramide 20 mg co-administered with placebo, intravenously	Metoclopramide 10 + Placebo n=72 Participants Metoclopramide 10 mg co-administered with placebo, intravenously	Metoclopramide 10+Diphenhydramine n=71 Participants Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
Number of Participants With Akathisia	9 participants	12 participants	5 participants	8 participants

Adverse Events

Metoclopramide 20mg+Diphenhydramine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Metoclopramide 20+Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Metoclopramide 10 + Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Metoclopramide 10+Diphenhydramine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. BW Friedman

Montefiore Medical Center

Phone: 718-920-6626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place