Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)
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|ClinicalTrials.gov Identifier: NCT00898677|
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : July 14, 2009
Last Update Posted : March 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headache||Drug: rizatriptan benzoate Drug: Comparator: sumatriptan Drug: Comparator: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1268 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Examine the Safety, Tolerability, and Efficacy of Single Oral Doses of MK0462 5 mg, MK0462 10 mg, and Sumatriptan 100 mg for Acute Treatment of Migraine|
|Study Start Date :||September 1995|
|Actual Primary Completion Date :||May 1996|
|Actual Study Completion Date :||September 1996|
rizatriptan 5 mg
Drug: rizatriptan benzoate
single dose administration of 5mg rizatriptan (by Mouth) p.o.
rizatriptan 10 mg
Drug: rizatriptan benzoate
single dose administration of 10 mg rizatriptan p.o.
Active Comparator: 3
sumatriptan 100 mg
Drug: Comparator: sumatriptan
single dose administration of sumatriptan 100 p.o.
Other Name: sumatriptan
Placebo Comparator: 4
Drug: Comparator: Placebo
placebo to rizatriptan
- Pain Relief at 2 Hours After Dose [ Time Frame: 2 hours after dose ]Patients reporting pain relief defined as a reduction of headache 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 to Relief Within 2 Hours After Dose [ Time Frame: within 2 hours after dose ]Patients reporting time to relief defined as the first time point at which a patient reported headache severity grade 1 or 0 (mild pain or no headache) within 2 hours after dose
- Pain Free at 2 Hours After Dose [ Time Frame: 2 hours after dose ]Patients pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each patient rated headache severity on a 4-point scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).
- Functional Status at 2 Hours After Dose [ Time Frame: 2 hours after dose ]Patients with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each patient rated functional disability on a 4-grade scale (0 = no functional disability; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 = unable to carry out daily activities, requires bed rest).
- Nausea at 2 Hours After Dose [ Time Frame: 2 hours after dose ]Patients who recorded the presence or absence of nausea 2 hours after dose
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00898677
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|