Ignite Creation Date:
2025-12-24 @ 11:21 PM
Ignite Modification Date:
2025-12-25 @ 9:04 PM
Study NCT ID:
NCT01339156
Status:
TERMINATED
Last Update Posted:
2012-11-22
First Post:
2011-04-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of P3914 to Evaluate the Safety, Tolerability, Food Effect & Pharmacokinetics in Healthy Male Subjects and Efficacy & Safety of P3914 in Patients With Acute Dental Pain
Sponsor:
Piramal Enterprises Limited
Organization:
Study Overview
Official Title:
Randomized, Double-blind, Placebo-controlled Phase I-Ib Study of P3914 to Evaluate the Safety, Tolerability, Food Effect & Pharmacokinetics in Healthy Male Subjects and Efficacy & Safety of P3914 in Patients With Acute Dental Pain
Status:
TERMINATED
Status Verified Date:
2012-11
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:
P3914 a pro-drug of Naproxen, characterized by naproxen (COX inhibiting moiety) linked to a NO moiety is intended for the treatment of pain and inflammation. The rationale behind development of P3914 is to maintain the analgesic, antipyretic and anti-inflammatory activity of naproxen and enhance GI safety by virtue of release of NO besides with no major effect on blood pressure on long-term administration.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: