Study to Test a Marketed Product in the Treatment of Migraine-associated Nausea

Phase 3

Completed

• Conditions: Migraine

• Registration Number: NCT00250458
• Lead Sponsor: Organon and Co

Brief Summary

Study to test the effectiveness of a marketed drug in the treatment of migraine-associated nausea.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-11-07
• Study First Submitted QC: 2005-11-07
• Study First Posted: 2005-11-08
• Study Start: 2006-03
• Primary Completion: 2006-10
• Study Completion: 2006-10
• Results First Submitted: 2009-09-21
• Results First Submitted QC: 2010-05-25
• Results First Posted: 2010-06-23
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-01
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 346

Inclusion Criteria

• 6-month history of migraine, moderate to severe migraine attacks with nausea, 1-6 migraine attacks per month

Exclusion Criteria

• Heart disease, high blood pressure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Participants With Elimination of Nausea at 2 Hours Postdose	At 2 hours after treatment	Participants reporting the absence of nausea at 2 hours post treatment. Absence or presence of nausea was recorded by the participants in an electronic diary. Absence is defined as no nausea at 2 hours post-treatment.

Secondary Outcome Measures

Name	Time	Method
Participants With Pain Relief at 2 Hours Postdose	2 hours after treatment	Participants reporting pain relief defined as a reduction of pain 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.