Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266786
Status:
COMPLETED
Last Update Posted:
2017-02-08
First Post:
2005-12-16
Brief Title:
Safety and Efficacy of Multiple Doses of Intranasal Ketorolac in Postoperative Pain Following Major Abdominal Surgery
Sponsor:
Egalet Ltd
Organization:
Egalet Ltd
Study Overview
Official Title:
A Phase 3 Double-Blind Randomized Study of the Safety Tolerability and Analgesic Efficacy of Multiple Doses of Ketorolac Tromethamine Administered Intranasally for Postoperative Pain Following Major Abdominal Surgery
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Ketorolac has been marketed for several years in other forms tablet and injectable for the short-term relief of pain This study will test whether a new dosage form nasal spray containing ketorolac is effective at relieving the pain of major abdominal surgery and will also assess product safety Previous studies with the nasal spray have suggested that it is similar to the previously approved injectable form in effectiveness for pain relief and in its safety profile
Patients will be randomized in a 21 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level 40 on a scale of 100 following surgery After the first dose subjects will receive study drug every 6 hours for 48 hours and then as needed up to 4 times a day for a total of 5 days If pain is not adequately relieved by the study drug subjects will be given morphine sulfate or other standard analgesics Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing
Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study and will be given physical examinations including nasal evaluations before and during the clinical trial A small amount of blood will be drawn for routine clinical laboratory testing
Patients will be randomized in a 21 ratio to receive intranasal ketorolac or placebo when the pain reaches a moderate level 40 on a scale of 100 following surgery After the first dose subjects will receive study drug every 6 hours for 48 hours and then as needed up to 4 times a day for a total of 5 days If pain is not adequately relieved by the study drug subjects will be given morphine sulfate or other standard analgesics Follow-up safety evaluations will occur about 1 and 2 weeks after the start of dosing
Subjects will be asked to answer questions about their pain relief and any possible side effects of the drug during the study and will be given physical examinations including nasal evaluations before and during the clinical trial A small amount of blood will be drawn for routine clinical laboratory testing
Detailed Description:
None
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