Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea
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)
2 other identifiers
interventional
346
0 countries
N/A
Brief Summary
Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2006
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 7, 2005
CompletedFirst Posted
Study publicly available on registry
November 8, 2005
CompletedStudy Start
First participant enrolled
March 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2006
CompletedResults Posted
Study results publicly available
June 23, 2010
CompletedFebruary 3, 2022
February 1, 2022
7 months
November 7, 2005
September 21, 2009
February 1, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Participants With Elimination of Nausea at 2 Hours Postdose
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.
At 2 hours after treatment
Secondary Outcomes (1)
Participants With Pain Relief at 2 Hours Postdose
2 hours after treatment
Study Arms (2)
1
EXPERIMENTALRizatriptan (MK0462)10 mg orally disintegrating tablet/oral lyophilisate
2
PLACEBO COMPARATORmatching placebo
Interventions
One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack.
Eligibility Criteria
You may qualify if:
- month history of migraine, moderate to severe migraine attacks with nausea, 1-6 migraine attacks per month
You may not qualify if:
- Heart disease, high blood pressure
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
Related Publications (1)
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. doi: 10.1111/j.1526-4610.2007.00954.x. Epub 2007 Nov 28.
PMID: 18047500BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 7, 2005
First Posted
November 8, 2005
Study Start
March 1, 2006
Primary Completion
October 1, 2006
Study Completion
October 1, 2006
Last Updated
February 3, 2022
Results First Posted
June 23, 2010
Record last verified: 2022-02