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Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo

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ClinicalTrials.gov Identifier: NCT01986270
Recruitment Status : Completed
First Posted : November 18, 2013
Last Update Posted : November 18, 2013
Sponsor:
Information provided by (Responsible Party):
Pfizer

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.

Condition or disease Intervention/treatment Phase
Migraine With or Without Aura Drug: Placebo Drug: Eletriptan 40 mg Drug: Eletriptan 80 mg Drug: Sumatriptan 25 mg Drug: Sumatriptan 50 mg Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1141 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : December 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 25 mg Drug: Sumatriptan 25 mg
25mg oral

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




Primary Outcome Measures :
  1. Headache response at 1 hour after the first dose for 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. Pain-free response at 1 hour after the first dose for the first attack. [ Time Frame: 1 hour ]
    A pain free response was defined as an improvement from a severe or moderate headache at baseline to an absent headache post-dose.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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): NCT01986270


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: NCT01986270     History of Changes
Other Study ID Numbers: A160-104
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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Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Sumatriptan
Eletriptan
Vasoconstrictor Agents
Serotonin 5-HT1 Receptor Agonists
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs