Prochlorperazine Versus Acetaminophen, Aspirin, and Caffeine for the Treatment of Acute Migraine

NCT01629329 | Terminated Phase 4 Results

• 1 other identifier: 4258
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this randomized, double blind study is to demonstrate that one dose oral "excedrin migraine" (acetaminophen, aspirin and caffeine) is not inferior when compared to one dose of intravenous prochlorperazine for the treatment of acute migraine headaches in the emergency department.

Conditions

Migraine Headaches

Keywords

Headache; prochlorperazine; excedrin migraine; treatment efficacy; pain scores

Outcome Measures

Primary Outcomes (1)

• Mean Difference From Baseline of VAS Pain Scores

  0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

  60 minutes from drug administration

Secondary Outcomes (1)

• Number of Reported Adverse Side-effects

  30, 90, and 120 minutes from drug administration

Study Arms (2)

Aspirin, Acetaminophen, Caffeine pills

ACTIVE COMPARATOR

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

Prochlorperazine 10mg

ACTIVE COMPARATOR

Patients will receive active compound of Prochlorperazine 10mg via IV syringe and 2 unmarked placebo pills

Drug: Prochlorperazine 10mg

Interventions

Aspirin, Acetaminophen, Caffeine pills DRUG

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)

Also known as: Excedrin

Aspirin, Acetaminophen, Caffeine pills

Prochlorperazine 10mg DRUG

One time dose of Prochlorperazine 10mg/2ml given IV slow push. Simultaneous administration of 2 unmarked placebo pills.

Also known as: Compazine

Prochlorperazine 10mg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years or older
• Headache must meet the IHS criteria for migraine or probable migraine
• out of 4 of following:
• Unilateral location
• Throbbing (pulsating) quality
• Moderate to severe intensity (inhibits/prohibits daily activities)
• Exacerbation with moderate activity or mild activity
• During HA, at least 1 out of 3 of following:
• Nausea and/or vomiting
• Photophobia
• Phonophobia

You may not qualify if:

• Known allergy to study medications
• Pregnancy
• \< 18 years old
• Inability to provide written, informed consent
• Patients with positive lumbar puncture or positive CT scan for suspected secondary headache
• History of peptic ulcer disease
• History of liver failure
• History of coagulopathy
• Gastrointestinal bleeding within the last 3 months
• Previous gastrointestinal bleeding with non-steroidal anti-inflammatory medications
• Ingestion of other pain medications within the previous six hours deemed to put the patient at risk of exceeding a toxic dose of ASA or acetaminophen (\> 100mg/kg for ASA or acetaminophen)
• Vomiting within one hour of receiving oral study medications.

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead

Study Sites (1)

Albert Einstein Medical Center

Philadelphia, Pennsylvania, 19141, United States

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Aspirin; Acetaminophen; acetaminophen, aspirin, caffeine drug combination; Prochlorperazine

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Acetanilides; Anilides; Amides; Aniline Compounds; Amines; Phenothiazines; Sulfur Compounds; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

0 Participants analyzed. PI has left the institution. Efforts made to contact were unsuccessful. No data available

Results Point of Contact

• Title: Kamran Mohiuddin, Director Clinical Research Emergency Department
• Organization: EINSTEIN MEDICAL CENTER

MOHIUDDK@EINSTEIN.EDU

2154562313

Study Officials

• Kenneth Deitch, DO

  Albert Einstein Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2012
• First Posted: June 27, 2012
• Study Start: November 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: July 1, 2014
• Last Updated: March 18, 2020
• Results First Posted: March 18, 2020

Record last verified: 2014-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)