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

Last updated on May 10, 2018

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Study Location
Contact
1-800-718-1021
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
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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

- 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.

NCT01986270
Pfizer
Completed
Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo

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Comparative Study of Oral Eletriptan (40mg and 80mg), Oral Sumatriptan (25mg and 50mg) and Placebo
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
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.
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 25 mg
    25mg oral
  • Drug: Sumatriptan 50 mg
    50mg 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 25 mg
    Intervention: Drug: Sumatriptan 25 mg
  • Experimental: Sumatriptan 50 mg
    Intervention: Drug: Sumatriptan 50 mg
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1141
January 1998
January 1998   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT01986270
A160-104
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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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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