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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | August 14, 2006 | ||||
| Last Updated Date | May 19, 2008 | ||||
| Start Date ICMJE | August 2006 | ||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
One hour pain scores | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00364806 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
One hour, two hour and 24 hour pain, functional disability scores, and side effect profiles. | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | A Clinical Trial Comparing Two Different Medications to Determine Which One is Better for Patients With an Acute Migraines in the Emergency Department | ||||
| Official Title ICMJE | Prochlorperazine Verus Metoclopramide for the Treatment of Acute Migraine in the Emergency Department Setting | ||||
| 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. |
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| 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. |
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| Study Phase | Phase IV | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Double-Blind, Active Control, Parallel Assignment, Bio-equivalence Study | ||||
| Condition ICMJE | Migraine | ||||
| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 76 | ||||
| Completion Date | March 2007 | ||||
| Primary Completion Date | March 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00364806 | ||||
| Responsible Party | Benjamin friedman, Montefiore Medical Center | ||||
| Study ID Numbers ICMJE | Migraine 3 | ||||
| Study Sponsor ICMJE | Montefiore Medical Center | ||||
| Collaborators ICMJE | Albert Einstein College of Medicine of Yeshiva University | ||||
| Investigators ICMJE |
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| Information Provided By | Montefiore Medical Center | ||||
| Verification Date | May 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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