Ignite Creation Date:
2024-05-05 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00293657
Status:
COMPLETED
Last Update Posted:
2012-12-03
First Post:
2006-02-15
Brief Title:
Study of Lornoxicam or Placebo for Acute Treatment of the Headache of Migraine
Sponsor:
POZEN
Organization:
POZEN
Study Overview
Official Title:
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
Status Verified Date:
2012-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None