Text Size

The Montefiore Metoclopramide Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Benjamin Friedman, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00475306
First received: May 16, 2007
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
Results First Received: July 11, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Factorial Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Nausea
Extrapyramidal Symptoms
Interventions: Drug: metoclopramide 10 mg
Drug: Diphenhydramine 25 mg
Drug: Placebo
Drug: Metoclopramide 20 mg

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients who presented to one ED with nausea were eligible for participation

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Metoclopramide 20 mg+Diphenhydramine     Metoclopramide 20+Placebo     Metoclopramide 10 + Placebo     Metoclopramide 10+Diphenhydramine  
STARTED     73     72     72     72  
COMPLETED     72 [1]   71 [2]   72     71 [3]
NOT COMPLETED     1     1     0     1  
Protocol Violation                 1                 1                 0                 1  
[1] 1 patient had resolution of nausea prior and did not receive the investigational medication
[2] For 1 patient, data collection was incomplete and results could not be analyzed
[3] 1 patient's intravenous line infiltrated.



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
Metoclopramide 20mg+Diphenhydramine Metoclopramide 20 mg co-administered with diphenhydramine 25mg, 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 10mg co-administered with diphenhydramine 25mg, intravenously
Total Total of all reporting groups

Baseline Measures
    Metoclopramide 20mg+Diphenhydramine     Metoclopramide 20+Placebo     Metoclopramide 10 + Placebo     Metoclopramide 10+Diphenhydramine     Total  
Number of Participants  
[units: participants]
 		  72     71     72     71     286  
Age  
[units: Years]
Mean ± Standard Deviation 		  39  ± 12     42  ± 14     40  ± 13     39  ± 13     40  ± 13  
Gender [1]
[units: participants]
 		         
Female     52     52     55     51     210  
Male     20     19     17     20     76  
[1] Please note: Only patients who completed the study are reported here



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Nausea Scale   [ Time Frame: 60 minutes ]
  Show Outcome Measure 1

2.  Secondary:   Number of Participants With Akathisia   [ Time Frame: 60 minutes ]
  Show Outcome Measure 2


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Dr. BW Friedman
Organization: Montefiore Medical Center
phone: 718-920-6626
e-mail: befriedm@montefiore.org


No publications provided


Responsible Party: Benjamin Friedman, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00475306     History of Changes
Other Study ID Numbers: 07-01-005
Study First Received: May 16, 2007
Results First Received: July 11, 2011
Last Updated: November 28, 2012
Health Authority: United States: Institutional Review Board