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Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study

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NCT01986088

Last updated on May 11, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Migraine With or Without Aura
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-76 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Eligible patients were men and women with a minimum age limit of 18 years of age (in
Canada there was also an age limit of 65 years) who were expected to have at least one
attack of migraine with or without aura, as defined by the International Headache
Society (IHS) criteria,15 every 6 weeks.

- Patients had to be capable of taking study medication as outpatients and recording the
effects.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Pregnant or breast-feeding women and those not using adequate contraception were
excluded from the trial.

- Patients with frequent nonmigrainous headache, atypical migraine that had not
previously responded to therapy, migraine with prolonged aura, familial hemiplegic
migraine, basilar migraine, or migrainous infarction were excluded from the trial.

NCT01986088
Pfizer
Completed
Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study

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Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study
A Multicentre, Double Blind, Double Dummy, Parallel Group, Placebo Controlled, Study of Two Dose Levels of Oral Eletriptan and Two Dose Levels Oral Sumatriptan Given for the Acute Treatment of Migraine(With and Without Aura).
A previously published, placebo-controlled, head-to-head comparator study found eletriptan to have superior efficacy to oral sumatriptan 100 mg in treating a single acute migraine attack. The goal of the current study was to extend the findings of that study by examining the efficacy of eletriptan compared with both 50- and 100-mg doses of sumatriptan; and to evaluate the comparative efficacy of eletriptan and sumatriptan across additional important clinical outcomes. In particular, early response (at 1 hour), sustained response (without need for additional treatment) at 24 hours, and consistency of response across multiple attacks were examined.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Migraine With or Without Aura
  • Drug: Placebo
    matching placebo
  • Drug: Eletriptan 40 mg
    40mg oral
  • Drug: Eletriptan 80 mg
    80mg oral
  • Drug: Sumatriptan 50 mg
    50mg oral
  • Drug: Sumatriptan 100 mg
    100mg oral
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: Eletriptan 40 mg
    Intervention: Drug: Eletriptan 40 mg
  • Experimental: Eletriptan 80 mg
    Intervention: Drug: Eletriptan 80 mg
  • Experimental: Sumatriptan 50 mg
    Intervention: Drug: Sumatriptan 50 mg
  • Experimental: Sumatriptan 100 mg
    Intervention: Drug: Sumatriptan 100 mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1008
January 1998
January 1998   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Eligible patients were men and women with a minimum age limit of 18 years of age (in Canada there was also an age limit of 65 years) who were expected to have at least one attack of migraine with or without aura, as defined by the International Headache Society (IHS) criteria,15 every 6 weeks.
  • Patients had to be capable of taking study medication as outpatients and recording the effects.

Exclusion Criteria:

  • Pregnant or breast-feeding women and those not using adequate contraception were excluded from the trial.
  • Patients with frequent nonmigrainous headache, atypical migraine that had not previously responded to therapy, migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, or migrainous infarction were excluded from the trial.
Sexes Eligible for Study: All
18 Years to 76 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01986088
A160-318
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2013

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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