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A Trial to Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine

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: NCT00174395
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : January 27, 2021
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 15, 2005
Last Update Posted Date January 27, 2021
Study Start Date  ICMJE March 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)		 To evaluate pain free response at 2 hours with eletriptan 40mg in mild pain compared to moderate to severe pain intensity of migraine in early intervention.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2006)		 To demonstrate the efficacy of early intervention with eletriptan 40mg on mild compared to moderate to severe migraine pain include the following clinical outcomes: pain-free at 0.5, 1, 1.5, 4 and 24 hours; sustained pain-free, migraine recurrence
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)		 To demonstrate the efficacy of early intervention with eletriptan 40mg on mild compared to moderate to severe migraine pain across the following clinical outcomes: pain-free at 0.5, 1, 1.5, 4 and 24 hours; sustained pain-free migraine recurrence
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial to Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine
Official Title  ICMJE A Multi-Center, Open-Label, Randomized, Parallel-Group Study of the Effects of Eletriptan 40mg on Mild vs Moderate to Severe Pain Intensity of Migraine in Early Intervention.
Brief Summary To evaluate the efficacy of early intervention (dosing within 2 hours of onset of the migraine attack) with eletriptan 40mg on mild versus moderate to severe pain intensity of migraine.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Migraine
Intervention  ICMJE Drug: eletriptan
Study Arms  ICMJE Not Provided
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
Enrollment  ICMJE
 (submitted: September 9, 2005)		 220
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE October 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Diagnosis of migraine with or without aura according to the recent IHS criteria.
  • Migraine headaches must have been present for more than one year.
  • History in the last 3 months of 1 to 4 acute attacks of migraine headache per month.

Exclusion Criteria:

  • Subjects with current or past history of coronary artery disease.
  • Pregnant or breastfeeding women.
  • Subjects who have chronic daily headaches.
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 Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00174395
Other Study ID Numbers  ICMJE A1601107
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Not Provided
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