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A phase 3, 53 weeks study on analgesic efficacy and safety of naproxcinod (HCT 3012): 26-week, randomized, parallel-group, double-blind, placebo (13 weeks)- and naproxen (26 weeks)-controlled, multicenter study of naproxcinod (375 mg Bid and 750 mg Bid) with a 26-week naproxen-controlled safety follow-up in subjects with osteoarthritis of the knee, and a 1-week post-treatment safety follow-up

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Trial Profile

A phase 3, 53 weeks study on analgesic efficacy and safety of naproxcinod (HCT 3012): 26-week, randomized, parallel-group, double-blind, placebo (13 weeks)- and naproxen (26 weeks)-controlled, multicenter study of naproxcinod (375 mg Bid and 750 mg Bid) with a 26-week naproxen-controlled safety follow-up in subjects with osteoarthritis of the knee, and a 1-week post-treatment safety follow-up

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 22 Jun 2011

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At a glance

  • Drugs Naproxcinod (Primary) ; Naproxen
  • Indications Musculoskeletal pain; Osteoarthritis
  • Focus Pharmacodynamics; Registrational; Therapeutic Use
  • Sponsors NicOx

    • Most Recent Events

    • 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.
    • 01 May 2010 Prespecified pooled pharmacodynamic analysis presented at the 25th Annual Scientific Meeting of the American Society of Hypertension.
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