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: February 14, 2008

Verified by: Merck, February 2008

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

Overall Status: Completed

Estimated Enrollment: 318

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, Placebo Control, Parallel Assignment, Efficacy Study

Outcome Measures for this Clinical Trial

Primary:

  • Percentage of patients with elimination of migraine-associated nausea at 2 hours post-dose as recorded in patient diary 2 hours post-dose No

Secondary:

  • Percentage of patients with a 2 hour pain relief: 4-point headache severity scale as recorded in patient diary 2 hours 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

Clinical Trials Locations, Contact Details, and Sponsors

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 18, 2008

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

Clinical Trials Authorship and Review

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.