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| Study Type: | Interventional |
|---|---|
| Study Design: | Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment |
| Condition: |
Migraine |
| Interventions: |
Drug: Comparator: rizatriptan benzoate Drug: Comparator: Placebo |
Participant Flow
| Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations |
|---|
| Phase III First Patient In: 03-October-2007 Last Patient Last Visit: 08-April-2008 13 outpatient centers worldwide (10 United States, 3 Germany) |
| Significant events and approaches for the overall study following participant enrollment, but prior to group assignment |
|---|
| Participants were assessed, using the protocol inclusion and exclusion criteria, at Visit 1, and if eligible were randomized at that same visit. |
| Description | |
|---|---|
| Rizatriptan 10 mg ODT | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack |
| Placebo | Matching placebo; one dose, treatment of a single migraine attack |
| Rizatriptan 10 mg ODT | Placebo | |
|---|---|---|
| STARTED | 103 | 104 |
| COMPLETED | 92 | 96 |
| NOT COMPLETED | 11 | 8 |
| Lost to Follow-up | 2 | 0 |
| Physician Decision | 0 | 1 |
| Withdrawal by Subject | 0 | 1 |
| Lack of Qualifying Event | 9 | 6 |
Baseline Characteristics
| Description | |
|---|---|
| Rizatriptan 10 mg ODT | Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack |
| Placebo | Matching placebo; one dose, treatment of a single migraine attack |
| Rizatriptan 10 mg ODT | Placebo | Total | |
|---|---|---|---|
|
Number of Participants [units: participants] |
103 | 104 | 207 |
|
Age [units: years] Mean ( Full Range ) |
41 ( 19 to 69 ) |
44 ( 18 to 66 ) |
42.5 ( 18 to 69 ) |
|
Gender [units: participants] |
|||
| Female | 90 | 96 | 186 |
| Male | 13 | 8 | 21 |
|
Race/Ethnicity, Customized [units: participants] |
|||
| Black or African American | 4 | 3 | 7 |
| White | 95 | 100 | 195 |
| Asian | 2 | 1 | 3 |
| Multi-Racial | 2 | 0 | 2 |
Outcome Measures
| 1. Primary: | Number of Participants Who Are Pain Free at 2 Hours Post-Dose |
| 2. Secondary: | Number of Participants With 24-Hour Sustained Pain Freedom |
| 3. Secondary: | Number of Participants With no Rescue Use up to 24 Hours Post-Dose |
| 4. Secondary: | Number of Participants With Absence of Photophobia at 2 Hours Post-dose |
| 5. Secondary: | Number of Participants With Absence of Phonophobia at 2 Hours Post-dose |
| 6. Secondary: | Number of Participants With Absence of Nausea at 2 Hours Post-dose |
| 7. Secondary: | Number of Participants With Absence of Functional Disability at 2 Hours Post-Dose |
More Information
| All Principal Investigators ARE employed by the organization sponsoring the study. |
| Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data |
|---|
| In the Adverse Events section, all non-serious adverse experiences reported are post-treatment, up to the time of taking rescue medication or 14 days post-dose, whichever comes first. |
| Responsible Party: | Merck & Co., Inc. ( Executive Vice President, Clinical and Quantitative Sciences ) |
| Study ID Numbers: | 2007_547, MK0462-081 |
| Study First Received: | August 13, 2007 |
| Results First Received: | March 12, 2009 |
| Last Updated: | July 7, 2009 |
| ClinicalTrials.gov Identifier: | NCT00516737 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
