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A Trial to Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine

Primary Purpose

Migraine

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
eletriptan
Sponsored by
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Migraine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of migraine with or without aura according to the recent IHS criteria. Migraine headaches must have been present for more than one year. History in the last 3 months of 1 to 4 acute attacks of migraine headache per month. Exclusion Criteria: Subjects with current or past history of coronary artery disease. Pregnant or breastfeeding women. Subjects who have chronic daily headaches.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

To evaluate pain free response at 2 hours with eletriptan 40mg in mild pain compared to moderate to severe pain intensity of migraine in early intervention.

Secondary Outcome Measures

To demonstrate the efficacy of early intervention with eletriptan 40mg on mild compared to moderate to severe migraine pain include the following clinical outcomes: pain-free at 0.5, 1, 1.5, 4 and 24 hours; sustained pain-free, migraine recurrence

Full Information

First Posted
September 9, 2005
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00174395
Brief Title
A Trial to Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine
Official Title
A Multi-Center, Open-Label, Randomized, Parallel-Group Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine in Early Intervention.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

4. Oversight

5. Study Description

Brief Summary
To evaluate the efficacy of early intervention (dosing within 2 hours of onset of the migraine attack) with eletriptan 40mg on mild versus moderate to severe pain intensity of migraine.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
220 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
eletriptan
Primary Outcome Measure Information:
Title
To evaluate pain free response at 2 hours with eletriptan 40mg in mild pain compared to moderate to severe pain intensity of migraine in early intervention.
Secondary Outcome Measure Information:
Title
To demonstrate the efficacy of early intervention with eletriptan 40mg on mild compared to moderate to severe migraine pain include the following clinical outcomes: pain-free at 0.5, 1, 1.5, 4 and 24 hours; sustained pain-free, migraine recurrence

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of migraine with or without aura according to the recent IHS criteria. Migraine headaches must have been present for more than one year. History in the last 3 months of 1 to 4 acute attacks of migraine headache per month. Exclusion Criteria: Subjects with current or past history of coronary artery disease. Pregnant or breastfeeding women. Subjects who have chronic daily headaches.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Edmonton
State/Province
Alberta
Country
Canada
Facility Name
Pfizer Investigational Site
City
Chilliwack
State/Province
British Columbia
Country
Canada
Facility Name
Pfizer Investigational Site
City
Coquitlam
State/Province
British Columbia
Country
Canada
Facility Name
Pfizer Investigational Site
City
Langley
State/Province
British Columbia
Country
Canada
Facility Name
Pfizer Investigational Site
City
North Vancouver
State/Province
British Columbia
Country
Canada
Facility Name
Pfizer Investigational Site
City
Penticton
State/Province
British Columbia
Country
Canada
Facility Name
Pfizer Investigational Site
City
Winnipeg
State/Province
Manitoba
Country
Canada
Facility Name
Pfizer Investigational Site
City
Bathurst
State/Province
New Brunswick
Country
Canada
Facility Name
Pfizer Investigational Site
City
Moncton
State/Province
New Brunswick
Country
Canada
Facility Name
Pfizer Investigational Site
City
St. John's
State/Province
Newfoundland and Labrador
Country
Canada
Facility Name
Pfizer Investigational Site
City
Halifax
State/Province
Nova Scotia
Country
Canada
Facility Name
Pfizer Investigational Site
City
Truro
State/Province
Nova Scotia
Country
Canada
Facility Name
Pfizer Investigational Site
City
Bolton
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Brampton
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Corunna
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Fort Erie
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Hamilton
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
London
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Markham
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Mississauga
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Newmarket
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Niagara Falls
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Woodstock
State/Province
Ontario
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montague
State/Province
Prince Edward Island
Country
Canada
Facility Name
Pfizer Investigational Site
City
Cowansville
State/Province
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Drummondville
State/Province
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Granby
State/Province
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sainte Julie
State/Province
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Sherbrooke
State/Province
Quebec
Country
Canada
Facility Name
Pfizer Investigational Site
City
Regina
State/Province
Saskatchewan
Country
Canada
Facility Name
Pfizer Investigational Site
City
Mount Pearl
Country
Canada
Facility Name
Pfizer Investigational Site
City
Quebec
Country
Canada

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A1601107&StudyName=A+Trial+to+Study+of+the+Effects+of+Eletriptan+40mg+on+Mild+vs+Moderate+to+Severe+Pain+Intensity+of+Migraine
Description
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Learn more about this trial

A Trial to Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine

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