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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00250458

First received: November 7, 2005

Last updated: October 30, 2015

Last verified: October 2015

History of Changes

Purpose

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

Condition	Intervention	Phase
Migraine	Drug: Comparator: Rizatriptan Drug: Comparator: Placebo	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment
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)

Resource links provided by NLM:

MedlinePlus related topics: Migraine Nausea and Vomiting

Drug Information available for: Rizatriptan Rizatriptan benzoate

U.S. FDA Resources

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

Participants With Elimination of Nausea at 2 Hours Postdose [ Time Frame: At 2 hours after treatment ]
Participants reporting the absence of nausea at 2 hours post treatment. Absence or presence of nausea was recorded by the participants in an electronic diary. Absence is defined as no nausea at 2 hours post-treatment.

Secondary Outcome Measures:

Participants With Pain Relief at 2 Hours Postdose [ Time Frame: 2 hours after treatment ]
Participants reporting pain relief defined as a reduction of pain severity from grades 2 or 3 (moderate or severe pain) at baseline to grades 0 or 1 (no headache or mild pain) at 2 hours after treatment.


Enrollment:	346
Study Start Date:	March 2006
Study Completion Date:	October 2006
Primary Completion Date:	October 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Rizatriptan (MK0462)10 mg orally disintegrating tablet/oral lyophilisate	Drug: Comparator: Rizatriptan One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack.
Placebo Comparator: 2 matching placebo	Drug: Comparator: Placebo One dose matching placebo to Rizatriptan to treat one migraine attack.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Additional Information:

MedWatch - FDA maintained medical product safety Information This link exits the ClinicalTrials.gov site

Merck: Patient & Caregiver U.S. Product Web Site This link exits the ClinicalTrials.gov site

Publications:

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. 2008 Mar;48(3):368-77. Epub 2007 Nov 28.


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00250458 History of Changes
Other Study ID Numbers:	0462-074 2005_081
Study First Received:	November 7, 2005
Results First Received:	September 21, 2009
Last Updated:	October 30, 2015

Additional relevant MeSH terms:


Migraine Disorders Headache Disorders, Primary Headache Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases	Rizatriptan Serotonin Receptor Agonists Serotonin Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 18, 2017

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