Effect of Metoclopramide Versus Sumatriptan for Emergency Department Treatment of Migraine Headache

NCT01791400 | Completed Phase 2 DMC

• 1 other identifier: ASD-1213-70
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine which drug makes lower migraine headache

Conditions

Migraine Disorders

Keywords

Metoclopramide; Sumatriptan; migraine; headache

Outcome Measures

Primary Outcomes (1)

• pain

  determining pain in Metoclopramide versus sumatriptan groups

  at one hour after prescription

Study Arms (2)

sumatriptan

OTHER

Patients who underwent 6 mg sumatriptan subcutaneous one time

Drug: Sumatriptan, injection, 6 mg, one time

Metoclopramide

OTHER

Patients who underwent 20 mg Metoclopramide intravenous one time

Drug: metoclopramide, injection,20mg, one time

Interventions

metoclopramide, injection,20mg, one time DRUG

metoclopramide, intravenous injection,20mg, one time

Also known as: plasil

Metoclopramide

Sumatriptan, injection, 6 mg, one time DRUG

Sumatriptan, subcutaneous injection, 6 mg, one time

sumatriptan

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years old and presented with acute headache similar to previous episodes,
• with or without phonophobia,
• photophobia,
• vomiting or nausea.

You may not qualify if:

• fever or neck stiffness,
• altered mental state,
• pregnancy,
• recent trauma or seizure (within 24 hours),
• focal neurological abnormality on physical examination,
• allergy to metoclopramide,
• hypertension,
• cardiovascular diseases.
• Also if the patients had taken a triptan or ergot during the last 24 hours were excluded from the study.

Sponsors & Collaborators

• Isfahan University of Medical Sciences: lead

Study Sites (1)

Al-zahra university hospital

Isfahan, Isfahan, Iran

Location

MeSH Terms

Conditions

Migraine Disorders; Headache

Interventions

Metoclopramide; Sumatriptan; Injections

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)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Sulfonamides; Sulfones; Sulfur Compounds; Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• babak masoumi, A.Professor

  Isfahan, Isfahan, Iran, Islamic Republic of

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant

Study Record Dates

• First Submitted: February 10, 2013
• First Posted: February 15, 2013
• Study Start: July 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: February 15, 2013

Record last verified: 2013-02

Locations

IR (1)