Expired Study
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Portsmouth, Virginia 23708


Purpose:

ED patients with acute migraine will be randomized to either prochlorperazine and Bendaryl OR imitrex. VAS for pain will be monitored, along with side effects. Primary outcome measure is improvement in pain scales between the groups.


Criteria:

Inclusion Criteria: - Acute migraine headache Exclusion Criteria: - Pregnant - Hypertension - Chest pain - < 18 - Allergy to any of the meds


Study is Available At:


Original ID:

P06-050


NCT ID:

NCT00573599


Secondary ID:


Study Acronym:


Brief Title:

Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department


Official Title:

Prochlorperazine vs Imitrex for Acute Migraine in the Emergency Department


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

50 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

United States Naval Medical Center, Portsmouth


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

66


Enrollment Type:

Actual


Overall Contact Information

Official Name:Frank Gutierrez, MD
Principal Investigator
US Navy

Study Dates

Start Date:February 2007
Completion Date:May 2007
Completion Type:Actual
Verification Date:December 2007
Last Changed Date:December 13, 2007
First Received Date:December 13, 2007

Study Outcomes

Outcome Type:Primary Outcome
Measure:Difference in pain measured by VAS
Time Frame:80 min
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Degree of sedation, nausea, akathisia
Time Frame:80 min
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:prochlorperazine and benadryl IV
Description:prochlorperazine and benadryl IV, saline subQ
Arm Name:1
Intervention Type:Drug
Name:Imitrex SubQ, saline IV
Description:Imitrex SubQ, saline IV
Arm Name:2

Study Arms

Study Arm Type:Experimental
Arm Name:1
Description:prochlorperazine and benadryl IV, saline subQ
Study Arm Type:Active Comparator
Arm Name:2
Description:imitrex SubQ, saline IV

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:United States Naval Medical Center, Portsmouth

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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