A dose titrated clinical trial with a placebo-controlled, double-blind, randomised, cross-over phase to demonstrate the efficacy of 400 microg Intranasal fentanyl (INFS) dose strength, and to evaluate 12 weeks safety and nasal tolerability of all dose strengths between 50 microg and 400 microg, in cancer patients with breakthrough pain.

Trial Profile

A dose titrated clinical trial with a placebo-controlled, double-blind, randomised, cross-over phase to demonstrate the efficacy of 400 microg Intranasal fentanyl (INFS) dose strength, and to evaluate 12 weeks safety and nasal tolerability of all dose strengths between 50 microg and 400 microg, in cancer patients with breakthrough pain.

Completed
Phase of Trial: Phase III

Latest Information Update: 29 Jan 2015

At a glance

  • Drugs Fentanyl (Primary)
  • Indications Cancer pain
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms NOSE-400
  • Sponsors Takeda
  • Most Recent Events

    • 01 Jan 2013 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
    • 21 Aug 2012 Planned End Date changed from 1 Jul 2012 to 1 Jan 2013 as reported by ClinicalTrials.gov.
    • 02 Sep 2011 Planned end date (Jul 2012) added as reported by ClinicalTrials.gov.
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