A 13-Week, Phase 3, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Bid and Naproxen 500 mg Bid, Controlled Study on the Efficacy on Signs and Symptoms, and Safety of Naproxcinod (HCT3012) 750 mg Bid, in Patients With Osteoarthritis of the Hip.

Trial Profile

A 13-Week, Phase 3, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo Bid and Naproxen 500 mg Bid, Controlled Study on the Efficacy on Signs and Symptoms, and Safety of Naproxcinod (HCT3012) 750 mg Bid, in Patients With Osteoarthritis of the Hip.

Completed
Phase of Trial: Phase III

Latest Information Update: 23 Nov 2013

At a glance

  • Drugs Naproxcinod (Primary) ; Naproxen
  • Indications Musculoskeletal pain; Osteoarthritis
  • Focus Adverse reactions; Pharmacodynamics; Registrational; Therapeutic Use
  • Sponsors NicOx
  • Most Recent Events

    • 27 Jul 2010 Results presented at 11th Annual Congress of the European League Against Rheumatism (EULAR) 2010
    • 23 Jul 2010 FDA does not approve NDA according to a media release from NICOX.
    • 03 May 2010 Undisclosed results from a pre-specified pooled analysis of the 301, 302 and 303 naproxcinod studies were presented at ASH 2010, according to a NicOx media release. The abstract has been published in the Journal of Clinical Hypertension 2010, 12 (s1), A5.
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