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Consumer Product Safety |
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Clinical Trial: Study to Test a Marketed Product in the Treatment of Migraine-Associated Nausea
This study is not yet open for patient recruitment.
Verified by Merck January 2006
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Purpose
Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.
| Condition | Intervention | Phase |
|---|---|---|
| Migraine | Drug: MK0462, rizatriptan benzoate / Duration of Treatment One (1) Day Drug: Comparator: placebo / Duration of Treatment One (1) Day | Phase III |
MedlinePlus related topics: Migraine
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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)
Further study details as provided by Merck:
Primary Outcomes: Percentage of patients with elimination of migraine-associated nausea at 2 hours postdose as recorded in patient diary
Secondary Outcomes: Percentage of patients with a 2 hour pain relief: 4-point headache severity scale as recorded in patient diary
Expected Total Enrollment: 318
Secondary Outcomes: Percentage of patients with a 2 hour pain relief: 4-point headache severity scale as recorded in patient diary
Expected Total Enrollment: 318
Study start: November 2005
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
Criteria
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00250458
Call For Site Information 1-888-577-8839
Study chairs or principal investigators
Medical Monitor, Study Director, Merck
More Information
Study ID Numbers: 2005_081
Last Updated: January 13, 2006
Record first received: November 7, 2005
ClinicalTrials.gov Identifier: NCT00250458
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-17
Last Updated: January 13, 2006
Record first received: November 7, 2005
ClinicalTrials.gov Identifier: NCT00250458
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-17
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