drugset / Trial / NCT01541930

An Open, Uncontrolled Study of GK567 in the Deodorization of Malodorous Fungating Neoplastic Tumours

NCT01541930

Phase 3 Completed 21 enrolled Galderma R&D
NaSingle-groupOpen-labelTreatment

Summary

This clinical trial objective is to investigate the safety and efficacy of GK567 to alleviate malodour of foul smelling, anaerobically infected fungating neoplastic tumours, over 14 days of treatment. The clinical hypothesis is that the success rate is no worse than 70% in the population of interest, where success for a patient is defined as a smell score of 0 or 1 at Day 14/end of treatment, as assessed by the Study Investigator.

Timeline

Start
2012-04
Primary completion
2012-12
Completion
2012-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Metronidazole Small molecule 0.75 %
Subject Metronidazole Small molecule 30 g

Indications