NCT00483717

Efficacy and Safety of Intranasal Ketorolac for the Acute Treatment of Migraine

A Phase 2, Double-blind, Randomized, Placebo-controlled Study of the Safety, Tolerability, and Analgesic Efficacy of Ketorolac Tromethamine Administered Intranasally for the Acute Treatment of Migraine

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 173 (actual)
• Sponsor: Egalet Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.

Detailed description

Evaluates the efficacy and safety of using ketorolac as a nasal spray for the acute treatment of migraine.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	Ketorolac tromethamine	31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)
DRUG	Placebo	Intranasal (IN) placebo

Timeline

• Start date: 2007-07-01
• Primary completion: 2008-01-01
• Completion: 2008-01-01
• First posted: 2007-06-07
• Last updated: 2016-09-30
• Results posted: 2016-09-30

Locations

1 site across 1 country: Germany