Prochlorperazine Versus Acetaminophen, Aspirin, and Caffeine for the Treatment of Acute Migraine (Migraine)
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|ClinicalTrials.gov Identifier: NCT01629329|
Recruitment Status : Terminated (no difference found between two groups in a preliminary analysis)
First Posted : June 27, 2012
Last Update Posted : June 25, 2014
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headaches||Drug: Aspirin, Acetaminophen, Caffeine pills Drug: Prochlorperazine 10mg||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||93 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Double-blind Comparison of Single Dose Prochlorperazine Versus Acetaminophen, Aspirin and Caffeine for the Treatment of Acute Migraine in the Emergency Department.|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||April 2014|
|Actual Study Completion Date :||April 2014|
Active Comparator: Aspirin, Acetaminophen, Caffeine pills
Patients receiving AAC(acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet)will receive 2 pills with active compound and placebo syringe with 2 ml of saline.
Drug: Aspirin, Acetaminophen, Caffeine pills
One time dose of 2 pills each containing acetaminophen 250mg, aspirin 250mg and caffeine 65mg in each tablet. Simultaneous administration of placebo(5ml of saline administered IV)
Other Name: Excedrin
Active Comparator: Prochlorperazine 10mg
Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills
Drug: Prochlorperazine 10mg
One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills.
Other Name: Compazine
- Mean difference from baseline of VAS pain scores [ Time Frame: 60 minutes from drug administration ]Primary endpoint is defined as the mean difference from baseline of pain scores at 60min.
- Number of reported adverse side-effects [ Time Frame: 30, 90, and 120 minutes from drug administration ]Secondary endpoints will also be assessed at 30min, 90min and 120min. Additional secondary endpoints will be in the number of reported adverse side-effects, defined as muscle spasm, tiredness, extreme restlessness, GI upset, vomiting in the ED and treatment failure rate.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01629329
|United States, Pennsylvania|
|Albert Einstein Medical Center|
|Philadelphia, Pennsylvania, United States, 19141|
|Principal Investigator:||Kenneth Deitch, DO||Albert Einstein Medical Center|