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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00250458
Recruitment Status : Completed
First Posted : November 8, 2005
Results First Posted : June 23, 2010
Last Update Posted : November 2, 2015
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

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

Condition or disease Intervention/treatment Phase
Migraine Drug: Comparator: Rizatriptan Drug: Comparator: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 346 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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)
Study Start Date : March 2006
Primary Completion Date : October 2006
Study Completion Date : October 2006

Resource links provided by the National Library of Medicine

Drug Information available for: Rizatriptan
U.S. FDA Resources

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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 :
  1. 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.

Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00250458

Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Study Director: Medical Monitor Merck Sharp & Dohme Corp.

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp. Identifier: NCT00250458     History of Changes
Other Study ID Numbers: 0462-074
First Posted: November 8, 2005    Key Record Dates
Results First Posted: June 23, 2010
Last Update Posted: November 2, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Migraine Disorders
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs