Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel, Multiple-Dose Study of the Analgesic Efficacy and Safety of IV Acetaminophen (APAP) Versus Placebo Over 48 Hours(Hrs) for the Treatment of Postoperative Pain After Gynecologic Surgery
Phase of Trial: Phase III
Latest Information Update: 18 Jun 2015
At a glance
- Drugs Paracetamol (Primary)
- Indications Postoperative pain
- Focus Registrational; Therapeutic Use
- Sponsors Mallinckrodt Inc.
- 02 Nov 2010 According to a Cadence Pharmaceuticals media release, the US FDA has approved OFIRMEV (IV parcetamol) for the management of mild to moderate pain, the management of moderate to severe pain with adjunctive opioid analgesics, and the reduction of fever.
- 11 Jan 2008 Primary endpoint not met according to a Cadence Pharmaceuticals media release.
- 17 Sep 2007 Status changed from recruiting to completed.