Back to resultsStudy to Test a Marketed Product in the Treatment of Migraine-associated Nausea
Primary Purpose
Migraine
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Comparator: Rizatriptan
Comparator: Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
Rizatriptan (MK0462)10 mg orally disintegrating tablet/oral lyophilisate
matching placebo
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Participants With Pain Relief at 2 Hours Postdose
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00250458
Brief Title
Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea
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 Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
October 2006 (Actual)
Study Completion Date
October 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief Summary
Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
346 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Rizatriptan (MK0462)10 mg orally disintegrating tablet/oral lyophilisate
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
matching placebo
Intervention Type
Drug
Intervention Name(s)
Comparator: Rizatriptan
Intervention Description
One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack.
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo
Intervention Description
One dose matching placebo to Rizatriptan to treat one migraine attack.
Primary Outcome Measure Information:
Title
Participants With Elimination of Nausea at 2 Hours Postdose
Description
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.
Time Frame
At 2 hours after treatment
Secondary Outcome Measure Information:
Title
Participants With Pain Relief at 2 Hours Postdose
Description
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.
Time Frame
2 hours after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
18047500
Citation
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.
Results Reference
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Learn more about this trial
Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea
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