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Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Extension Protocols MK-0462-022, MK-0462-025, MK-0462-029)

Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Migraine Disorders

Intervention: Rizatriptan 5 mg (Drug); Rizatriptan 10 mg (Drug); Standard Care (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Merck Sharp & Dohme Corp.

Summary

This record describes pooled data for three extension studies: MK-0462-022 (NCT00897949); MK-0462-025 (NCT00899379); and MK-0462-029 (NCT00897104). These studies examined the long-term safety and efficacy of rizatriptan used for the treatment of acute migraine and migraine recurrence.

Clinical Details

Official title: Long-Term Exposure to Rizatriptan 5-mg and 10-mg Oral Tablet (Combined Protocols 022, 025, 029)

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Primary outcome:

Percent of Patient's Headaches With Pain Relief at 2 Hours After the Initial Dose of Test Drug

Number of Participants With Serious Clinical Adverse Experiences

Number of Participants With Drug-related Clinical Adverse Experiences

Number of Participants Who Discontinued Due to Clinical Adverse Experiences

Number of Participants With Drug-related Lab Adverse Experiences

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Participant took part in study MK-0462-022, MK-0462-025, or MK-0462-029

- History of migraine headache

Locations and Contacts

Additional Information

Starting date: March 1995
Last updated: February 13, 2015

Page last updated: August 23, 2015

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