Phase 3 N=346 Randomized Double-blind Treatment

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

Migraine

Bottom Line

View on ClinicalTrials.gov: NCT00250458 ↗

Enrolled (actual)

346

Serious AEs

0.0%

Results posted

Jun 2010

Primary outcome: Primary: Participants With Elimination of Nausea at 2 Hours Postdose — 130; 57; 55; 35 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Comparator: Rizatriptan (Drug); Comparator: Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Organon and Co
Primary completion: Oct 2006

Outcome Measures

Outcome	Result	p-value
PRIMARY Participants With Elimination of Nausea at 2 Hours Postdose	130; 57; 55; 35	—
SECONDARY Participants With Pain Relief at 2 Hours Postdose	129; 50; 56; 42	—

Summary

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

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00250458). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.