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

NCT00174395

Last updated date
Study Location
Pfizer Investigational Site
Edmonton, Alberta, , Canada
Contact
1-800-718-1021

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Migraine
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

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


- Subjects with current or past history of coronary artery disease.


- Pregnant or breastfeeding women.


- Subjects who have chronic daily headaches.

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NCT00174395
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  2. Chilliwack, British Columbia
  3. Coquitlam, British Columbia
  4. Langley, British Columbia
  5. North Vancouver, British Columbia
  6. Penticton, British Columbia
  7. Winnipeg, Manitoba
  8. Bathurst, New Brunswick
  9. Moncton, New Brunswick
  10. St. John's, Newfoundland and Labrador
  11. Halifax, Nova Scotia
  12. Truro, Nova Scotia
  13. Bolton, Ontario
  14. Brampton, Ontario
  15. Corunna, Ontario
  16. Fort Erie, Ontario
  17. Hamilton, Ontario
  18. London, Ontario
  19. Markham, Ontario
  20. Mississauga, Ontario
  21. Newmarket, Ontario
  22. Niagara Falls, Ontario
  23. Woodstock, Ontario
  24. Montague, Prince Edward Island
  25. Cowansville, Quebec
  26. Drummondville, Quebec
  27. Granby, Quebec
  28. Montreal, Quebec
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Advanced Information
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
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP