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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 : November 18, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Migraine With or Without Aura Drug: Placebo Drug: Eletriptan 40 mg Drug: Eletriptan 80 mg Drug: Sumatriptan 50 mg Drug: Sumatriptan 100 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1008 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: 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).
Study Start Date : November 1996
Actual Primary Completion Date : January 1998
Actual Study Completion Date : January 1998

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Migraine

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
matching placebo

Experimental: Eletriptan 40 mg Drug: Eletriptan 40 mg
40mg oral

Experimental: Eletriptan 80 mg Drug: Eletriptan 80 mg
80mg oral

Experimental: Sumatriptan 50 mg Drug: Sumatriptan 50 mg
50mg oral

Experimental: Sumatriptan 100 mg Drug: Sumatriptan 100 mg
100mg oral




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Headache severity [ Time Frame: .5, 1, 2, 4 and 24 hours ]
  2. Pain-free response [ Time Frame: .5, 1, 2, 4 and 24 hours ]
  3. Functional response [ Time Frame: .5, 1, 2, 4 and 24 hours ]
  4. Presence or absence of nausea, photophobia, and phonophobia [ Time Frame: .5, 1, 2, 4 and 24 hours ]


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Ages Eligible for Study:   18 Years to 76 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986088


Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
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Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01986088     History of Changes
Other Study ID Numbers: A160-318
First Posted: November 18, 2013    Key Record Dates
Last Update Posted: November 18, 2013
Last Verified: November 2013
Additional relevant MeSH terms:
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Sumatriptan
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Eletriptan
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs