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

Organon

Status and phase: Completed; Phase 3

Conditions: Migraine Headache

Treatments: Drug: rizatriptan benzoate; Drug: Comparator: sumatriptan; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00898677

2009_591

0462-030

Details and patient eligibility

About

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.

Enrollment: 1,268 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,268 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

rizatriptan 5 mg

Treatment:

Drug: rizatriptan benzoate

Drug: rizatriptan benzoate

2

Experimental group

Description:

rizatriptan 10 mg

Treatment:

Drug: rizatriptan benzoate

Drug: rizatriptan benzoate

3

Active Comparator group

Description:

sumatriptan 100 mg

Treatment:

Drug: Comparator: sumatriptan

4

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Comparator: Placebo