Back to resultsRizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)
Primary Purpose
Migraine Headache
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
rizatriptan benzoate
rizatriptan benzoate
Comparator: sumatriptan
Comparator: Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Migraine Headache
Eligibility Criteria
Inclusion Criteria:
- Patient had at least a 6-month history of migraine, with or without aura
- Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions.
- Patient was judged to be in good health, apart from migraine
Exclusion Criteria:
- Patient was pregnant or a nursing mother
- Patient had abused drugs or alcohol within 12 months prior to entering the study
- Patient had a history of cardiovascular disease
- Patient had clinically significant Electrocardiography (ECG) abnormality
- Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
- Patient received treatment with an investigational device or compound within 30 days of the study start
- Patient typically suffered from less then 1 or more than 8 attacks of migraine per month
- Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
- Patient had hypersensitivity to sumatriptan
- Patient had participated in any previous study involving rizatriptan
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Active Comparator
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
rizatriptan 5 mg
rizatriptan 10 mg
sumatriptan 100 mg
placebo
Outcomes
Primary Outcome Measures
Pain Relief at 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
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
Secondary Outcome Measures
Pain Free at 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
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
Patients who recorded the presence or absence of nausea 2 hours after dose
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00898677
Brief Title
Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
September 1995 (undefined)
Primary Completion Date
May 1996 (Actual)
Study Completion Date
September 1996 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief Summary
A study to compare rizatriptan 10 mg verse sumatriptan 100 mg in the treatment of migraine attacks and duration of relief provided. This study will also provide additional efficacy data on rizatriptan 5 mg and 10 mg for the treatment of migraine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Migraine Headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
1268 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
rizatriptan 5 mg
Arm Title
2
Arm Type
Experimental
Arm Description
rizatriptan 10 mg
Arm Title
3
Arm Type
Active Comparator
Arm Description
sumatriptan 100 mg
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
placebo
Intervention Type
Drug
Intervention Name(s)
rizatriptan benzoate
Other Intervention Name(s)
rizatriptan, MK0462
Intervention Description
single dose administration of 5mg rizatriptan (by Mouth) p.o.
Intervention Type
Drug
Intervention Name(s)
rizatriptan benzoate
Other Intervention Name(s)
rizatriptan, MK0462
Intervention Description
single dose administration of 10 mg rizatriptan p.o.
Intervention Type
Drug
Intervention Name(s)
Comparator: sumatriptan
Other Intervention Name(s)
sumatriptan
Intervention Description
single dose administration of sumatriptan 100 p.o.
Intervention Type
Drug
Intervention Name(s)
Comparator: Placebo
Intervention Description
placebo to rizatriptan
Primary Outcome Measure Information:
Title
Pain Relief at 2 Hours After Dose
Description
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 Frame
2 hours after dose
Title
Time to Relief Within 2 Hours After Dose
Description
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
Time Frame
within 2 hours after dose
Secondary Outcome Measure Information:
Title
Pain Free at 2 Hours After Dose
Description
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).
Time Frame
2 hours after dose
Title
Functional Status at 2 Hours After Dose
Description
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).
Time Frame
2 hours after dose
Title
Nausea at 2 Hours After Dose
Description
Patients who recorded the presence or absence of nausea 2 hours after dose
Time Frame
2 hours after dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient had at least a 6-month history of migraine, with or without aura
Patient was male, or if female must have been postmenopausal, surgically sterilized, or taking adequate contraceptive precautions.
Patient was judged to be in good health, apart from migraine
Exclusion Criteria:
Patient was pregnant or a nursing mother
Patient had abused drugs or alcohol within 12 months prior to entering the study
Patient had a history of cardiovascular disease
Patient had clinically significant Electrocardiography (ECG) abnormality
Patient had a resting systolic blood pressure of greater than 145 mm Hg or diastolic of less than 95 mm Hg at screening
Patient received treatment with an investigational device or compound within 30 days of the study start
Patient typically suffered from less then 1 or more than 8 attacks of migraine per month
Patient had difficulty in distinguishing his/her migraine attacks from tension or interval headaches
Patient had hypersensitivity to sumatriptan
Patient had participated in any previous study involving rizatriptan
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Citations:
PubMed Identifier
19222588
Citation
Ho TW, Rodgers A, Bigal ME. Impact of recent prior opioid use on rizatriptan efficacy. A post hoc pooled analysis. Headache. 2009 Mar;49(3):395-403. doi: 10.1111/j.1526-4610.2009.01346.x. Epub 2008 Feb 12.
Results Reference
background
PubMed Identifier
11284463
Citation
Tfelt-Hansen P, Teall J, Rodriguez F, Giacovazzo M, Paz J, Malbecq W, Block GA, Reines SA, Visser WH. Oral rizatriptan versus oral sumatriptan: a direct comparative study in the acute treatment of migraine. Rizatriptan 030 Study Group. Headache. 1998 Nov-Dec;38(10):748-55. doi: 10.1046/j.1526-4610.1998.3810748.x.
Results Reference
result
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Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)
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