Trial intelligence / Profile preview

Rizatriptan ODT for Migraine-Associated Nausea

NCT00250458Phase 3

Key facts

Status
Completed
Start
Mar 2006
Primary completion
Oct 2006
Modality
Small Molecules
Conditions
migraine
01

Overview

Phase 3, randomised, double-blind trial in migraine comparing Rizatriptan with Placebo (2 arms). Primary endpoint: Participants With Elimination of Nausea at 2 Hours Postdose. Started Mar 2006; status: completed.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Rizatriptan

    Rizatriptan 10 mg ODT

  • Placebo

    Matching Placebo

03

Who it enrols

Patients with a 6-month history of migraine experiencing 1-6 moderate to severe attacks with nausea per month. Patients with heart disease or high blood pressure are excluded.

04

Endpoints

Primary

  • Participants With Elimination of Nausea at 2 Hours Postdose

Secondary

  • Participants With Pain Relief at 2 Hours Postdose

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