- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00250458
Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea
February 1, 2022 updated by: Organon and Co
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 to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
346
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 2
matching placebo
|
One dose matching placebo to Rizatriptan to treat one migraine attack.
|
Experimental: 1
Rizatriptan (MK0462)10 mg orally disintegrating tablet/oral lyophilisate
|
One dose Rizatriptan 10 mg orally disintegrating tablet / oral lyophilisate to treat one migraine attack.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At 2 hours after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
2 hours after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2006
Primary Completion (Actual)
October 1, 2006
Study Completion (Actual)
October 1, 2006
Study Registration Dates
First Submitted
November 7, 2005
First Submitted That Met QC Criteria
November 7, 2005
First Posted (Estimate)
November 8, 2005
Study Record Updates
Last Update Posted (Actual)
February 3, 2022
Last Update Submitted That Met QC Criteria
February 1, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0462-074
- 2005_081
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Fondazione I.R.C.C.S. Istituto Neurologico Carlo...CompletedMigraine With Aura | Migraine in ChildrenItaly
-
The Cleveland ClinicWithdrawnMigraine | Migraine Disorders | Headache Disorders, Primary | Migraine Headache | Migraine Without Aura | Migraine With Aura | Headache, MigraineUnited States
Clinical Trials on Comparator: Rizatriptan
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Organon and CoCompleted
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