Effect of Metoclopramide Versus Sumatriptan for Emergency... | NCT01791400

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

NCT01791400

Sponsor

Isfahan University of Medical Sciences

Status

Completed

Last Update Posted

Feb 15, 2013Estimated

Enrollment

124Actual

Phase

Phase 2

Conditions

Migraine Disorders

Interventions

metoclopramide, injection,20mg, one time
Sumatriptan, injection, 6 mg, one time

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2009

Primary Completion Date

Nov 2010Actual

Completion Date

Nov 2010Actual

First Submitted Date

Feb 10, 2013

First Submission Date that Met QC Criteria

Feb 13, 2013

First Posted Date

Feb 15, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2013

Last Update Posted Date

Feb 15, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hamidreza Shemshaki, Research Assistant, Isfahan University of Medical SciencesPrincipal Investigator

Lead Sponsor

Isfahan University of Medical SciencesOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

There are different options to manage benign headache in emergency department.The investigators compared Intravenous metoclopramide with Subcutaneous sumatriptan to relieve pain in emergency department.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

124Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
metoclopramide, injection,20mg, one time	Drug	metoclopramide, intravenous injection,20mg, one time	Metoclopramide

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
pain	determining pain in Metoclopramide versus sumatriptan groups	at one hour after prescription

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

20-60 years old and presented with acute headache similar to previous episodes,
with or without phonophobia,
photophobia,
vomiting or nausea.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
babak masoumi, A.Professor	Isfahan, Isfahan, Iran, Islamic Republic of	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Al-zahra university hospital		Isfahan	Isfahan		Iran

Condition Browse Module

MeSH Terms

ID	Term
D008881	Migraine Disorders
D006261	Headache

Ancestor Terms

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D008787	Metoclopramide
D018170	Sumatriptan
D007267	Injections

Ancestor Terms

ID	Term
D001549	Benzamides
D000577	Amides
D009930	Organic Chemicals
D062366	para-Aminobenzoates

Browse Leaves

Not provided

Browse Branches

Not provided