Trial Outcomes & Findings for Prochlorperazine Versus Acetaminophen, Aspirin, and Caffeine for the Treatment of Acute Migraine (NCT NCT01629329)
NCT ID: NCT01629329
Last Updated: 2020-03-18
Results Overview
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
TERMINATED
PHASE4
93 participants
60 minutes from drug administration
2020-03-18
Participant Flow
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Participant milestones
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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.
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)
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Prochlorperazine 10mg
Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills
Prochlorperazine 10mg: One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills.
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Overall Study
STARTED
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0
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0
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Overall Study
COMPLETED
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0
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0
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Overall Study
NOT COMPLETED
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0
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Prochlorperazine Versus Acetaminophen, Aspirin, and Caffeine for the Treatment of Acute Migraine
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 60 minutes from drug administrationPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 30, 90, and 120 minutes from drug administrationPopulation: 0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available
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.
Outcome measures
Outcome data not reported
Adverse Events
Aspirin, Acetaminophen, Caffeine Pills
Prochlorperazine 10mg
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Kamran Mohiuddin, Director Clinical Research Emergency Department
EINSTEIN MEDICAL CENTER
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place