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

NCT ID: NCT01541930

Last Updated: 2014-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-04-30
• Study Completion Date: 2012-12-31

Brief 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.

Conditions

Malodorous Infected Cutaneous Ulcer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

GK567

GK567: Metronidazole Gel 0.75% Once or twice daily, for 14 days, up to 30g

Group Type: EXPERIMENTAL

GK567

Intervention Type: DRUG

Once or twice daily, for 14 days, up to 30 g per day

Interventions

GK567

Once or twice daily, for 14 days, up to 30 g per day

Intervention Type: DRUG

Other Intervention Names

GK567: Metronidazole Gel 0.75%

Eligibility Criteria

Inclusion Criteria

• The subject is a male or female aged between 20 years or older.
• The subject has a cutaneous fungating neoplastic tumour with a smell that suggests established or early infection, with a minimum score of 2 (i.e. mildly offensive smell) on a 0-4 smell scale, (based on the Study investigator's assessment)

Exclusion Criteria

• The subject is currently receiving systemic antibiotics or received in the last 2 weeks,
• The subject is currently receiving systemic or topical Metronidazole or received in the last week,
• The subject is currently receiving topical antibiotics or received such treatment applied on cutaneous fungating neoplastic tumour in the last 1 week,
• The subject already receives any topical treatment on the cutaneous fungating neoplastic tumour

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Galderma R&D

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Galderma investigational site

Kanagawa, , Japan

Galderma investigational site

Tokyo, , Japan

Countries

Japan

Other Identifiers

RDT.07.SPR.27013

Identifier Type: -

Identifier Source: org_study_id