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

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00250458

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: Headache Migraine Nausea and Vomiting

Drug Information available for: Rizatriptan Benzoate Rizatriptan Potassium benzoate

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 Outcome Measures:

Percentage of patients with elimination of migraine-associated nausea at 2 hours post-dose as recorded in patient diary [ Time Frame: 2 hours post-dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage of patients with a 2 hour pain relief: 4-point headache severity scale as recorded in patient diary [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	318
Study Start Date:	March 2006
Estimated Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Eligibility

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00250458

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Publications:

Responsible Party:	Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2005_081, MK0462-074
Study First Received:	November 7, 2005
Last Updated:	February 14, 2008
ClinicalTrials.gov Identifier:	NCT00250458
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Benzoates
Migraine Disorders
Headache
Central Nervous System Diseases
Headache Disorders, Primary

Nausea
Rizatriptan
Brain Diseases
Serotonin
Headache Disorders

Additional relevant MeSH terms:

Serotonin Agonists
Neurotransmitter Agents
Serotonin Agents
Molecular Mechanisms of Pharmacological Action

Physiological Effects of Drugs
Nervous System Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009