A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Cobiprostone for the Prevention of Severe Oral Mucositis in Subjects With Head and Neck Cancer (HNC)

Trial Profile

A Multicenter, Randomized, Placebo-controlled, Double-blinded Study of the Efficacy, Safety, and Pharmacokinetics of Cobiprostone for the Prevention of Severe Oral Mucositis in Subjects With Head and Neck Cancer (HNC)

Discontinued
Phase of Trial: Phase II

Latest Information Update: 12 Sep 2016

At a glance

  • Drugs Cobiprostone (Primary)
  • Indications Stomatitis
  • Focus Therapeutic Use
  • Sponsors Sucampo Pharmaceuticals
  • Most Recent Events

    • 11 Jul 2016 According to a Sucampo Pharmaceuticals media release, the company announced the decision to discontinue the development of cobiprostone based on the results of a prespecified futility analysis of this trial. The futility analysis indicated that the clinical benefit of cobiprostone was insufficient to support continuation of the study.
    • 11 Jul 2016 Status changed from recruiting to discontinued, according to a Sucampo media release.
    • 20 May 2016 Treatment arms changed from 3 to 2 with removal of Cobiprostone 15 mcg dose.
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