MK0462 5 mg, Sumatriptan 50 mg, and Placebo Comparison Study (0462-029)
|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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897104
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|