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

NCT00483717 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2016-09-30

Study results available
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Summary

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

Conditions

Interventions

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

Sponsors & Collaborators

  • Egalet Ltd

    lead INDUSTRY

Principal Investigators

  • Roger Whiting, Ph D · American Regent, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-07-31
Primary Completion
2008-01-31
Completion
2008-01-31

Countries

  • Germany

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00483717 on ClinicalTrials.gov