Acute Dental Pain Clinical Trial
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
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment