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

Verified by: Merck, June 2010
First Received: November 7, 2005 | Last Updated: June 24, 2010 | Phase: Phase 3 | Start Date: March 2006
Overall Status: Completed | Estimated Enrollment: 346
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Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea...

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)”

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

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • 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

  • Participants With Elimination of Nausea at 2 Hours Postdose
    • Time Frame: At 2 hours after treatment
      Safety Issue?: No

Secondary Measures

  • Participants With Pain Relief at 2 Hours Postdose
    • Time Frame: 2 hours after treatment
      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 Investigator Information

Lead Investigator: Merck Industry

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 February 09, 2012

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

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

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