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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp. Identifier:
First received: November 7, 2005
Last updated: October 30, 2015
Last verified: October 2015
Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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 identifier: NCT00250458

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

Additional Information:
Responsible Party: Merck Sharp & Dohme Corp. 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
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Migraine Disorders
Brain Diseases
Central Nervous System Diseases
Headache Disorders
Headache Disorders, Primary
Nervous System Diseases
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Physiological Effects of Drugs
Serotonin Agents
Serotonin Receptor Agonists processed this record on May 26, 2016