MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)
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|ClinicalTrials.gov Identifier: NCT00897104|
Recruitment Status : Completed
First Posted : May 12, 2009
Results First Posted : July 23, 2010
Last Update Posted : March 4, 2015
|Condition or disease||Intervention/treatment||Phase|
|Migraine Headache||Drug: rizatriptan benzoate (MK0462) Drug: Comparator: sumatriptan Drug: Comparator: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||933 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Placebo-Controlled, Parallel-Groups, Outpatient Study to Compare the Efficacy and Safety of MK0462 5 mg p.o. and Sumatriptan 50 mg p.o. for the Acute Treatment of Migraine|
|Study Start Date :||August 1995|
|Actual Primary Completion Date :||May 1996|
|Actual Study Completion Date :||September 1996|
Drug: rizatriptan benzoate (MK0462)
single dose 5 mg rizatriptan p.o.
Other Name: MK0462
Drug: Comparator: sumatriptan
single dose 50 mg sumatriptan p.o.
Placebo Comparator: 3
Drug: Comparator: Placebo
Placebo to rizatriptan or sumatriptan, single dose placebo tablet taken orally
- Pain Relief at 2 Hours After Treatment [ Time Frame: 2 hours after treatment ]Participants 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 Treatment [ Time Frame: within 2 hours after treatment ]Participants reporting time to relief (defined as the first time that a participant reported grade 0 or 1 in headache severity within 2 hours after treatment (for the comparison of rizatriptan 5 mg and sumatriptan 50 mg).
- Pain Free at 2 Hours After Treatment [ Time Frame: 2 hours after treatment ]Participants pain free (defined as a reduction of headache severity to grade 0 [no pain]) at 2 hours after treatment. Each participant rated headache severity on a 4-grade scale (0 = no headache; 1 = mild pain; 2 = moderate pain; 3 = severe pain).
- Lack of Functional Disability at 2 Hours After Treatment as Measured by the Level of Impairment in Daily Activities [ Time Frame: 2 hours after treatment ]Participants with no functional disability measured by the level of impairment to daily activities at 2 hours after treatment. Each participant rated functional disability on a 4-grade scale (0 =normal; 1 = daily activities mildly impaired; 2 = daily activities severely impaired; 3 =unable to carry out daily activities, required bed rest).
- Presence or Absence of Associated Symptoms (Photophobia, Phonophobia, Nausea, and Vomiting) at 2 Hours After Treatment [ Time Frame: 2 hours after treatment ]Participants who recorded the presence or absence of the associated symptoms photophobia, phonophobia, nausea, and vomiting at 2 hours after treatment.
- Participants Who Used Escape Medication 2 Hours After the Treatment Dose [ Time Frame: 2 hours after treatment ]Escape medication is defined as rescue medication for participants who experienced lack of efficacy from the study medication.
- Duration of Relief (Time to Recurrence From the Time of First Recorded Pain Relief [Grade = 0 or 1]) [ Time Frame: 24 hours ]Duration of relief or the time to recurrence from the time of first recorded pain relief (grade = 0 or 1) was calculated for responders who had a headache recurrence
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): NCT00897104
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|