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)
Phase of Trial: Phase II
Latest Information Update: 28 Feb 2018
At a glance
- Drugs Cobiprostone (Primary)
- Indications Stomatitis
- Focus Therapeutic Use
- Sponsors Sucampo AG
- 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.