An Open, Uncontrolled Study of GK567 in the Deodorization of Malodorous Fungating Neoplastic Tumours - Clinical Trial for Malodorous Infected Cutaneous Ulcer | NCT01541930

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

GK567

About this trial

This is an interventional treatment trial for Malodorous Infected Cutaneous Ulcer

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Galderma investigational site
Galderma investigational site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

GK567

Arm Description

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

Outcomes

Primary Outcome Measures

The Success Rate

The success rate, where success for a patient is defined as a smell score of 0 or 1 (0: No smell, 1: Smell present but not offensive) as assessed by the Study Investigator

Secondary Outcome Measures

Smell Score by Investigator

Tumour smell score was evaluated by the Study Investigator using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell, 3: Moderately offensive smell, 4: Extremely offensive smell

Smell Score by Nurse

Tumour smell score was evaluated by the Nurse using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell,3: Moderately offensive smell, 4: Extremely offensive smell

Smell Score by Patient

Tumour smell score was evaluated by the Patient using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell,3: Moderately offensive smell, 4: Extremely offensive smell

Appearance (Volume and Nature of Discharge at Cutaneous Ulcer)

Appearance score was evaluated by the Study Investigator using the following scale; 0: None (No discharge, e.g. frequency of dressing change: once daily), 1: Mild (Dressing need to be Changed twice daily), 2: Moderate (Dressing need to be Changed 3 times daily), 3: Marked (Dressing need to be Changed >3 times daily / Bloody).

Pain (Visual Analogue Scale)

The pain linked to the fungating tumour over the last 24 hours was evaluated by the patient. The pain was graded using a 100 mm linear visual analogical scale (graded from 0 mm = no pain to 100 mm = severe pain).

Full Information

NCT ID

NCT01541930

First Posted

February 24, 2012

Last Updated

January 7, 2014

Sponsor

Galderma R&D

1. Study Identification

Unique Protocol Identification Number

NCT01541930

Brief Title

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

Acronym

GK567

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2014

Overall Recruitment Status

Completed

Study Start Date

April 2012 (undefined)

Primary Completion Date

December 2012 (Actual)

Study Completion Date

December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Galderma R&D

4. Oversight

Data Monitoring Committee

No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malodorous Infected Cutaneous Ulcer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

21 (Actual)

8. Arms, Groups, and Interventions

Arm Title

GK567

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

GK567

Other Intervention Name(s)

GK567: Metronidazole Gel 0.75%

Intervention Description

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

Primary Outcome Measure Information:

Title

The Success Rate

Description

The success rate, where success for a patient is defined as a smell score of 0 or 1 (0: No smell, 1: Smell present but not offensive) as assessed by the Study Investigator

Time Frame

at Day 14 (end of treatment)

Secondary Outcome Measure Information:

Title

Smell Score by Investigator

Description

Tumour smell score was evaluated by the Study Investigator using the following scale; 0: No smell, 1: Smell present but not offensive, 2: Mildly offensive smell, 3: Moderately offensive smell, 4: Extremely offensive smell

Time Frame