NCT00293657

Study of Lornoxicam or Placebo for Acute Treatment of the Headache of Migraine.

A Randomized, Double-Blind, Single-Dose Study, Placebo-Controlled Evaluation of the Safety and Efficacy of Intravenous Lornoxicam in the Acute Treatment of the Headache of Migraine.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 150 (planned)
• Sponsor: POZEN · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: —

Summary

To determine whether a single dose of intravenous lornoxicam is superior to intravenous placebo for the acute treatment of moderate or severe headache associated with a single migraine attack in patients with a history of migraine. Two-thirds of patients in this study will receive a single dose of intravenous lornoxicam (8mg or 16 mg) and one-third of patients will receive a single dose of an intravenous placebo.

Detailed description

The headache of migraine is the primary symptom of this disorder that is estimated to affect approximately 10% of the population of developed countries, with the majority of persons with migraine being females between the ages of 20 and 50 years. Patients with migraine desire rapid and complete relief from headache and decreased frequency of recurrence over the 24 hours after treatment. Current treatments for migraine often provide incomplete pain relief and additional acute treatments are needed. Lornoxicam is a member of the NSAID class of anti-inflammatory drugs and is shown to be effective in the acute management of postoperative pain and arthritis. The current study will evaluate the efficacy of single doses of lornoxicam, administered intravenously, in treatment of the headache of migraine to determine possible future uses of this drug in this condition.

Conditions

• Headache (Migraine)

Interventions

Type	Name	Description
DRUG	Lornoxicam 8 mg
DRUG	Lornoxicam 16 mg
DRUG	Placebo

Timeline

• Start date: 2005-12-01
• Primary completion: 2006-04-01
• Completion: 2006-04-01
• First posted: 2006-02-17
• Last updated: 2012-12-03

Locations

23 sites across 1 country: United States