Rizatriptan 5 mg and 10 mg, Sumatriptan 100 mg, and Placebo Comparison Study (0462-030)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1268 participants

Study Classification

INTERVENTIONAL

Study Start Date

1995-09-30

Study Completion Date

1996-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Migraine Headache

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

rizatriptan 5 mg

Group Type EXPERIMENTAL

rizatriptan benzoate

Intervention Type DRUG

single dose administration of 5mg rizatriptan (by Mouth) p.o.

2

rizatriptan 10 mg

Group Type EXPERIMENTAL

rizatriptan benzoate

Intervention Type DRUG

single dose administration of 10 mg rizatriptan p.o.

3

sumatriptan 100 mg

Group Type ACTIVE_COMPARATOR

Comparator: sumatriptan

Intervention Type DRUG

single dose administration of sumatriptan 100 p.o.

4

placebo

Group Type PLACEBO_COMPARATOR

Comparator: Placebo

Intervention Type DRUG

placebo to rizatriptan

Interventions

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rizatriptan benzoate

single dose administration of 5mg rizatriptan (by Mouth) p.o.

Intervention Type DRUG

rizatriptan benzoate

single dose administration of 10 mg rizatriptan p.o.

Intervention Type DRUG

Comparator: sumatriptan

single dose administration of sumatriptan 100 p.o.

Intervention Type DRUG

Comparator: Placebo

placebo to rizatriptan

Intervention Type DRUG

Other Intervention Names

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rizatriptan MK0462 rizatriptan MK0462 sumatriptan

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No