Study to Test a Marketed Product in the Treatment of Migraine-Associated Nausea

Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea...

Date First Received: November 7, 2005

Last Updated: January 28, 2009

Verified by: Merck, January 2009

Clinical Trial Phase: Phase 3 | Start Date: March 2006

Overall Status: Completed

Estimated Enrollment: 346

Brief Summary

Official Title: “A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Elimination of Migraine-Associated Nausea in Migraine Patients Treated With Rizatriptan Orally Disintegrating Tablet (ODT)”

Condition Keyword(s):

Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: October 2006

Intervention(s) in this Clinical Trial

  • Drug: Comparator: Rizatriptan
    • One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack.
  • Drug: Comparator: Placebo
    • One dose matching placebo to Rizatriptan to treat one migraine attack.

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • Rizatriptan (MK0462)10 mg orally disintegrating tablet/oral lyophilisate
  • Placebo Comparator: 2
    • matching placebo

Outcome Measures for this Clinical Trial

Primary Measures

  • Percentage of patients with elimination of nausea at 2 hours postdose
    • Time Frame: 2 hours post-dose
      Safety Issue?: No

Secondary Measures

  • Percentage of patients with pain relief at 2 hours postdose
    • Time Frame: 2 hours post-dose
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • 6-month history of migraine, moderate to severe migraine attacks with nausea, 1-6 migraine attacks per month

Exclusion Criteria:

  • Heart disease, high blood pressure

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Merck

Overall Clinical Trial Officials and Contacts

Medical Monitor Study Director Merck  

Related Publications

References

Freitag F, Taylor FR, Hamid MA, Rodgers A, Hustad CM, Ramsey KE, Skobieranda F. Elimination of Migraine-Associated Nausea in Patients Treated with Rizatriptan Orally Disintegrating Tablet (ODT): A Randomized, Double-Blind, Placebo-Controlled Study. Headache. 2007 Nov 28; [Epub ahead of print]

Additional Information

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00250458

Study ID Number: 2005_081

ClinicalTrials.gov Identifier: NCT00250458

Health Authority: United States: Food and Drug Administration

MedWatch - FDA maintained medical product safety Information

PhRMA Clinical Study Results Database - web-based repository for clinical study results

Merck: Patient & Caregiver U.S. Product Web Site

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