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.
