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Trial record 1 of 1 for:    NCT01986088
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Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study

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ClinicalTrials.gov Identifier: NCT01986088
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : January 28, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )

Tracking Information
First Submitted Date  ICMJE November 11, 2013
First Posted Date  ICMJE November 18, 2013
Last Update Posted Date January 28, 2021
Study Start Date  ICMJE November 1996
Actual Primary Completion Date January 1998   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 11, 2013)
Headache response at 1 hour after treatment of the first attack. [ Time Frame: 1 hour ]
Headache response was defined as improvement from a severe or moderate headache at baseline to either a mild or absent headache post-dose.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 11, 2013)
  • Headache severity [ Time Frame: .5, 1, 2, 4 and 24 hours ]
  • Pain-free response [ Time Frame: .5, 1, 2, 4 and 24 hours ]
  • Functional response [ Time Frame: .5, 1, 2, 4 and 24 hours ]
  • Presence or absence of nausea, photophobia, and phonophobia [ Time Frame: .5, 1, 2, 4 and 24 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Eletriptan vs Sumatriptan: A Double-blind, Placebo-controlled, Multiple Migraine Attack Study
Official Title  ICMJE 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).
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Migraine With or Without Aura
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 11, 2013)
1008
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 1998
Actual Primary Completion Date January 1998   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 76 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01986088
Other Study ID Numbers  ICMJE A160-318
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer ( Pfizer's Upjohn has merged with Mylan to form Viatris Inc. )
Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP