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Safety and Efficacy of Eletriptan for the Treatment of Migraine in Subjects Unsuccessfully Treated With Nonsteroidal Anti-inflammatory Drugs

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00634985
Recruitment Status : Completed
First Posted : March 13, 2008
Last Update Posted : January 27, 2021
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE March 3, 2008
First Posted Date  ICMJE March 13, 2008
Last Update Posted Date January 27, 2021
Study Start Date  ICMJE November 2002
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
  • Headache severity and response post-treatment [ Time Frame: 2 hours ]
  • Functional response post-treatment [ Time Frame: 2 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 6, 2008)
  • Presence of associated symptoms including, nausea, vomiting, phonophobia, and photophobia at baseline and post-treatment [ Time Frame: 1, 2, 4, and 24 hours ]
  • Migraine recurrence post-treatment [ Time Frame: 1, 2, 4, and 24 hours ]
  • Time loss (from normal activities and from work) post-treatment [ Time Frame: 24 hours ]
  • Subject preference and acceptability post-treatment [ Time Frame: 24 hours and 12 weeks ]
  • Subject satisfaction post-treatment [ Time Frame: 2 and 24 hours ]
  • Adverse events [ Time Frame: Week 12 ]
  • Physical examination [ Time Frame: Week 12 ]
  • Vital signs [ Time Frame: Week 12 ]
  • Electrocardiogram [ Time Frame: Week 12 ]
  • Headache severity and response at baseline and post-treatment [ Time Frame: 1, 4 and 24 hours ]
  • Functional impairment severity and response at baseline and post-treatment [ Time Frame: 1, 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 Safety and Efficacy of Eletriptan for the Treatment of Migraine in Subjects Unsuccessfully Treated With Nonsteroidal Anti-inflammatory Drugs
Official Title  ICMJE A Multicentre, Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Eletriptan 40 Mg for the Treatment of Migraine (With or Without Aura) in Subjects Unsuccessfully Treated With NSAIDS
Brief Summary To assess the safety and efficacy of eletriptan for the treatment of migraine in subjects who had not been adequately treated with non-steroidal antiinflammatory drugs (NSAIDs)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE Drug: eletriptan
40 mg oral tablet for migraine attack; additional 40 mg oral tablet >2 hours from first dose if migraine reoccurred within 24 hours of achieving response
Study Arms  ICMJE Experimental: A
Intervention: Drug: eletriptan
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: April 22, 2011)		 120
Original Actual Enrollment  ICMJE
 (submitted: March 6, 2008)		 106
Actual Study Completion Date  ICMJE December 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Met International Headache Society diagnostic criteria for migraine with or without aura
  • Expected to suffer one to six acute migraine attacks per month based on past history
  • Experienced migraines for at least one year prior to entering study, and historically have not responded to NSAIDs

Exclusion Criteria:

  • Frequent migraine or frequent concomitant non-migrainous headache (average of >6 attacks per month)
  • Atypical migraines that consistently failed to respond to adequate medical therapy
  • Migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, or migraine with acute-onset aura
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00634985
Other Study ID Numbers  ICMJE A1601085
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Original Study Sponsor  ICMJE Pfizer
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