Back to resultsComparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo
Primary Purpose
Migraine With or Without Aura
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Placebo
Eletriptan 40 mg
Eletriptan 80 mg
Sumatriptan 25 mg
Sumatriptan 50 mg
Sponsored by
About this trial
This is an interventional treatment trial for Migraine With or Without Aura
Eligibility Criteria
Inclusion Criteria:
- Subjects who expected to suffer at least one acute attack of migraine, with or without aura, each 6 weeks (The diagnosis of migraine was to comply with the criteria proposed by the International Headache Society (IHS))
- Subjects capable of taking medication as outpatients, and recording the effects of such medication.
Exclusion Criteria:
- Pregnant or breast-feeding women
- Migraine subjects who also suffered from concomitant frequent (non-migrainous) headache, defined as more than six attacks per month on average.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Placebo Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
Placebo
Eletriptan 40 mg
Eletriptan 80 mg
Sumatriptan 25 mg
Sumatriptan 50 mg
Arm Description
Outcomes
Primary Outcome Measures
Headache response at 1 hour after the first dose for the first attack.
Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose.
Secondary Outcome Measures
Pain-free response at 1 hour after the first dose for the first attack.
A pain free response was defined as an improvement from a severe or moderate headache at baseline to an absent headache post-dose.
Full Information
NCT ID
NCT01986270
First Posted
October 30, 2013
Last Updated
January 26, 2021
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01986270
Brief Title
Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo
Official Title
A Multicenter, Double-blind, Placebo Controlled, Parallel Group, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels of of Oral Sumatriptan Given for the Acute Treatment of Migraine
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
December 1996 (undefined)
Primary Completion Date
January 1998 (Actual)
Study Completion Date
January 1998 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study was to compare the efficacy, toleration and safety of eletriptan 40mg and 80mg, with sumatriptan 25mg and 50mg, and placebo when given orally to subjects with an acute migraine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine With or Without Aura
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1141 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
Eletriptan 40 mg
Arm Type
Experimental
Arm Title
Eletriptan 80 mg
Arm Type
Experimental
Arm Title
Sumatriptan 25 mg
Arm Type
Experimental
Arm Title
Sumatriptan 50 mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching Placebo
Intervention Type
Drug
Intervention Name(s)
Eletriptan 40 mg
Intervention Description
40mg oral
Intervention Type
Drug
Intervention Name(s)
Eletriptan 80 mg
Intervention Description
80mg oral
Intervention Type
Drug
Intervention Name(s)
Sumatriptan 25 mg
Intervention Description
25mg oral
Intervention Type
Drug
Intervention Name(s)
Sumatriptan 50 mg
Intervention Description
50mg oral
Primary Outcome Measure Information:
Title
Headache response at 1 hour after the first dose for the first attack.
Description
Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose.
Time Frame
1 hour
Secondary Outcome Measure Information:
Title
Pain-free response at 1 hour after the first dose for the first attack.
Description
A pain free response was defined as an improvement from a severe or moderate headache at baseline to an absent headache post-dose.
Time Frame
1 hour
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:
Subjects who expected to suffer at least one acute attack of migraine, with or without aura, each 6 weeks (The diagnosis of migraine was to comply with the criteria proposed by the International Headache Society (IHS))
Subjects capable of taking medication as outpatients, and recording the effects of such medication.
Exclusion Criteria:
Pregnant or breast-feeding women
Migraine subjects who also suffered from concomitant frequent (non-migrainous) headache, defined as more than six attacks per month on average.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A160-104&StudyName=Comparative%20Study%20of%20Oral%20Eletriptan%20%2840mg%20and%2080mg%29%2C%20Oral%20Sumatriptan%20%2825mg%20and%2050mg%29%20and%20Placebo
Description
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Learn more about this trial
Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo
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