Viewing Study NCT00364806



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Last Modification Date: 2024-10-26 @ 9:26 AM
Study NCT ID: NCT00364806
Status: COMPLETED
Last Update Posted: 2018-04-17
First Post: 2006-08-14

Brief Title: Prochlorperazine vs Metoclopramide
Sponsor: Montefiore Medical Center
Organization: Montefiore Medical Center

Study Overview

Official Title: Prochlorperazine Verus Metoclopramide for the Treatment of Acute Migraine in the Emergency Department Setting
Status: COMPLETED
Status Verified Date: 2018-04
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Migraine headaches are a common reason for patients to present to an emergency department We are comparing two different medications to see which one is better for patients who present ot an emergency room with a migraine headache
Detailed Description: One-third of the five million headache patients who present to US Emergency Departments ED annually have a migraine headache The anti-emetic dopamine receptor antagonists have proven efficacy for migraines are at least as well-tolerated as triptans and enjoy wide-spread use in North American EDs However it is not yet clear which medication within this class and which dosage is optimal Therefore we propose a randomized clinical trial to compare the efficacy and tolerability of two standard medications for migraine

Specific Aim To compare the efficacy of metoclopramide versus prochlorperazine for the emergency department treatment of migraine headaches Both of these medications will be combined with diphenhydramine to prevent extra-pyramidal side effects

Patients will be enrolled as participants if they present to one of the participating EDs and consent to participate Medications will be administered as an intravenous drip over 15 minutes Rescue medication will be administered if needed after one hour A follow-up phone call will be conducted 24 hours after the ED visit

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None