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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Galderma R&D
ClinicalTrials.gov Identifier:
NCT01541930
First received: February 24, 2012
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Malodorous Infected Cutaneous Ulcer
Drug: GK567
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Galderma R&D:

Primary Outcome Measures:
  • The Success Rate [ Time Frame: at Day 14 (end of treatment) ] [ Designated as safety issue: No ]
    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 [ Time Frame: on Days 0 (baseline), 7, and 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: on Days 0 (baseline), 7, and 14 ] [ Designated as safety issue: No ]
    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 [ Time Frame: on Days 0 (baseline), 7, and 14 ] [ Designated as safety issue: No ]
    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) [ Time Frame: on Days 0 (baseline), 7, and 14 ] [ Designated as safety issue: No ]
    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) [ Time Frame: on Days 0 (baseline), 7, and 14 ] [ Designated as safety issue: No ]
    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).


Enrollment: 21
Study Start Date: April 2012
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GK567
GK567: Metronidazole Gel 0.75% Once or twice daily, for 14 days, up to 30g
Drug: GK567
Once or twice daily, for 14 days, up to 30 g per day
Other Name: GK567: Metronidazole Gel 0.75%

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01541930

Locations
Japan
Galderma investigational site
Kanagawa, Japan
Galderma investigational site
Tokyo, Japan
Sponsors and Collaborators
Galderma R&D
  More Information

No publications provided

Responsible Party: Galderma R&D
ClinicalTrials.gov Identifier: NCT01541930     History of Changes
Other Study ID Numbers: RDT.07.SPR.27013
Study First Received: February 24, 2012
Results First Received: November 13, 2013
Last Updated: January 7, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Skin Ulcer
Skin Diseases
Metronidazole
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antiprotozoal Agents
Antiparasitic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 21, 2014