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

This study has been completed.
Sponsor:
Information provided by:
Merck
ClinicalTrials.gov Identifier:
NCT00250458
First received: November 7, 2005
Last updated: June 24, 2010
Last verified: June 2010
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
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:

U.S. FDA Resources

Further study details as provided by Merck:

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: November 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
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00250458

Sponsors and Collaborators
Merck
Investigators
Study Director: Medical Monitor Merck
  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:

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00250458     History of Changes
Other Study ID Numbers: 2005_081, MK0462-074
Study First Received: November 7, 2005
Results First Received: September 21, 2009
Last Updated: June 24, 2010
Health Authority: United States: Food and Drug Administration

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
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 13, 2013