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Trial record 1 of 1 for:    NCT00632385
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Efficacy and Safety of Eletriptan for the Treatment of Migraine in Patients Not Satisfied With Rizatriptan Therapy

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ClinicalTrials.gov Identifier: NCT00632385
Recruitment Status : Completed
First Posted : March 10, 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 10, 2008
Last Update Posted Date January 27, 2021
Study Start Date  ICMJE January 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: March 3, 2008)
Change from baseline in headache pain severity [ Time Frame: 1, 2, 4, and 24 hours ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 3, 2008)
  • Functional impairment [ Time Frame: 1, 2, 4, and 24 hours ]
  • Work Productivity Questionnaire [ Time Frame: Week 10 ]
  • Time Loss [ Time Frame: Week 10 ]
  • Subject Preference Questionnaire [ Time Frame: Week 10 ]
  • Global Evaluation [ Time Frame: Week 10 ]
  • Subject Satisfaction Scale [ Time Frame: Week 10 ]
  • Associated Symptoms [ Time Frame: 1, 2, 4, and 24 hours ]
  • Use of Rescue Medication [ Time Frame: Week 10 ]
  • Adverse events [ Time Frame: Week 10 ]
  • Vital signs [ Time Frame: Week 10 ]
  • Physical examination [ Time Frame: Week 10 ]
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 Efficacy and Safety of Eletriptan for the Treatment of Migraine in Patients Not Satisfied With Rizatriptan Therapy
Official Title  ICMJE An Open-label Study of Eletriptan for the Acute Treatment of Migraine in Migraine Sufferers Who Are Dissatisfied With Rizatriptan Therapy
Brief Summary To assess the efficacy and safety of eletriptan for migraine headaches in subjects who were not satisfied with rizatriptan therapy
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, followed by 40 mg oral tablet if migraine reoccurred >2 hours from first dose and within 24 hours of first dose
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)
127
Original Actual Enrollment  ICMJE
 (submitted: March 3, 2008)
123
Actual Study Completion Date  ICMJE August 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of migraine headache according to International Headache Society criteria and migraine headaches for at least 1 year
  • Eletriptan naive
  • Previously treated with rizatriptan and failed to achieve a satisfactory response within the past 12 months

Exclusion Criteria:

  • Non-migraine headaches on average more than 6 days per month or have less than 24 hours of freedom from headache between migraine attacks
  • Migraine attacks that are atypical or chronic daily headaches
  • A history of migraine with prolonged aura, familial hemiplegic migraine, basilar migraine, migrainous infarction, migraine aura without headache, migraine with acute onset aura
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00632385
Other Study ID Numbers  ICMJE A1601092
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, 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