At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 21 enrolled
Drug / intervention
GK567drug
Likely dose
GK567 30 gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open, Uncontrolled Study Investigating the Safety and Efficacy of GK567 in the Deodorization of Malodorous Infected Cutaneous Fungating Neoplastic Tumours, Over 14 Days of Treatment
In Brief
A Phase 3 clinical trial evaluating GK567 for Malodorous Infected Cutaneous Ulcer. Completed, enrolled 21 participants across 2 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalodorous Infected Cutaneous Ulcer
CountriesJapan
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMar 2012
Enrollment StartApr 2012
Primary CompletionDec 2012
TodayJul 2026
First PostedMar 1, 2012
Enrollment StartApr 1, 2012
Primary CompletionDec 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.3 years ago
Interventions
GK567drug
Once or twice daily, for 14 days, up to 30 g per day