Trial Outcomes & Findings for An Open, Uncontrolled Study of GK567 in the Deodorization of Malodorous Fungating Neoplastic Tumours (NCT NCT01541930)
NCT ID: NCT01541930
Last Updated: 2014-02-06
Results Overview
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
COMPLETED
PHASE3
21 participants
at Day 14 (end of treatment)
2014-02-06
Participant Flow
April 2012 to December 2012 in Japan
Participant milestones
| Measure |
GK567
Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
|
|---|---|
|
Overall Study
STARTED
|
21
|
|
Overall Study
COMPLETED
|
20
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
GK567
Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
Baseline Characteristics
An Open, Uncontrolled Study of GK567 in the Deodorization of Malodorous Fungating Neoplastic Tumours
Baseline characteristics by cohort
| Measure |
GK567
n=21 Participants
Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
|
|---|---|
|
Age, Continuous
|
64.4 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
21 participants
n=5 Participants
|
|
Primary Disease
Breast Cancer
|
21 participants
n=5 Participants
|
|
Primary Disease
Other Cancer
|
0 participants
n=5 Participants
|
|
Skin Ulcer Size
|
68.6 cm^2
STANDARD_DEVIATION 35.4 • n=5 Participants
|
PRIMARY outcome
Timeframe: at Day 14 (end of treatment)Population: All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses. Only observed cases were part of the analyses. If the primary endpoint was missing, an additional analysis of this endpoint was performed using the last observation carried forward (LOCF) to impute the missing data.
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
Outcome measures
| Measure |
GK567
n=21 Participants
Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
|
GK567, Day 7
Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
|
GK567, Day 14
Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 due to subject's request.
|
|---|---|---|---|
|
The Success Rate
|
95.2 percentage of participants
Interval 79.3 to 99.8
|
—
|
—
|
SECONDARY outcome
Timeframe: on Days 0 (baseline), 7, and 14Population: All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.
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
Outcome measures
| Measure |
GK567
n=21 Participants
Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
|
GK567, Day 7
n=21 Participants
Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
|
GK567, Day 14
n=20 Participants
Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 due to subject's request.
|
|---|---|---|---|
|
Smell Score by Investigator
0: No smell
|
0 participants
|
11 participants
|
13 participants
|
|
Smell Score by Investigator
1: Smell present but not offensive
|
0 participants
|
5 participants
|
6 participants
|
|
Smell Score by Investigator
2: Mildly offensive smell
|
13 participants
|
2 participants
|
0 participants
|
|
Smell Score by Investigator
3: Moderately offensive smell
|
3 participants
|
3 participants
|
1 participants
|
|
Smell Score by Investigator
4: Extremely offensive smell
|
5 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: on Days 0 (baseline), 7, and 14Population: All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.
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
Outcome measures
| Measure |
GK567
n=21 Participants
Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
|
GK567, Day 7
n=21 Participants
Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
|
GK567, Day 14
n=20 Participants
Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 due to subject's request.
|
|---|---|---|---|
|
Smell Score by Nurse
0: No smell
|
1 participants
|
12 participants
|
15 participants
|
|
Smell Score by Nurse
1: Smell present but not offensive
|
3 participants
|
4 participants
|
4 participants
|
|
Smell Score by Nurse
2: Mildly offensive smell
|
9 participants
|
2 participants
|
1 participants
|
|
Smell Score by Nurse
3: Moderately offensive smell
|
3 participants
|
2 participants
|
0 participants
|
|
Smell Score by Nurse
4: Extremely offensive smell
|
5 participants
|
1 participants
|
0 participants
|
SECONDARY outcome
Timeframe: on Days 0 (baseline), 7, and 14Population: All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.
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
Outcome measures
| Measure |
GK567
n=21 Participants
Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
|
GK567, Day 7
n=21 Participants
Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
|
GK567, Day 14
n=20 Participants
Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 due to subject's request.
|
|---|---|---|---|
|
Smell Score by Patient
0: No smell
|
1 participants
|
9 participants
|
16 participants
|
|
Smell Score by Patient
1: Smell present but not offensive
|
8 participants
|
12 participants
|
4 participants
|
|
Smell Score by Patient
2: Mildly offensive smell
|
6 participants
|
0 participants
|
0 participants
|
|
Smell Score by Patient
3: Moderately offensive smell
|
4 participants
|
0 participants
|
0 participants
|
|
Smell Score by Patient
4: Extremely offensive smell
|
2 participants
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: on Days 0 (baseline), 7, and 14Population: All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.
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).
Outcome measures
| Measure |
GK567
n=21 Participants
Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
|
GK567, Day 7
n=21 Participants
Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
|
GK567, Day 14
n=20 Participants
Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 due to subject's request.
|
|---|---|---|---|
|
Appearance (Volume and Nature of Discharge at Cutaneous Ulcer)
3 Marked
|
5 participants
|
4 participants
|
2 participants
|
|
Appearance (Volume and Nature of Discharge at Cutaneous Ulcer)
0 None
|
1 participants
|
5 participants
|
7 participants
|
|
Appearance (Volume and Nature of Discharge at Cutaneous Ulcer)
1 Mild
|
12 participants
|
12 participants
|
10 participants
|
|
Appearance (Volume and Nature of Discharge at Cutaneous Ulcer)
2 Moderate
|
3 participants
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: on Days 0 (baseline), 7, and 14Population: All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.
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).
Outcome measures
| Measure |
GK567
n=21 Participants
Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g
|
GK567, Day 7
n=21 Participants
Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 7
|
GK567, Day 14
n=20 Participants
Metronidazole Gel 0.75%, Tumour smell score evaluated on Day 14. One patient was withdrawn on Day 7 due to subject's request.
|
|---|---|---|---|
|
Pain (Visual Analogue Scale)
|
28.3 mm
Standard Deviation 29.1
|
25.9 mm
Standard Deviation 27.1
|
22.2 mm
Standard Deviation 25.3
|
Adverse Events
GK567
Serious adverse events
| Measure |
GK567
n=21 participants at risk
Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30 g
|
|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
1/21 • Number of events 1 • Overall study, 14 days (treatment period)
|
|
General disorders
Fatigue
|
4.8%
1/21 • Number of events 1 • Overall study, 14 days (treatment period)
|
Other adverse events
| Measure |
GK567
n=21 participants at risk
Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30 g
|
|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin neoplasm bleeding
|
14.3%
3/21 • Number of events 3 • Overall study, 14 days (treatment period)
|
|
Nervous system disorders
Somnolence
|
9.5%
2/21 • Number of events 2 • Overall study, 14 days (treatment period)
|
|
General disorders
Fatigue
|
14.3%
3/21 • Number of events 3 • Overall study, 14 days (treatment period)
|
|
Investigations
Gamma-glutamyltransferase increased
|
9.5%
2/21 • Number of events 2 • Overall study, 14 days (treatment period)
|
|
Infections and infestations
Nasopharyngitis
|
4.8%
1/21 • Number of events 1 • Overall study, 14 days (treatment period)
|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
1/21 • Number of events 1 • Overall study, 14 days (treatment period)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.8%
1/21 • Number of events 1 • Overall study, 14 days (treatment period)
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.8%
1/21 • Number of events 1 • Overall study, 14 days (treatment period)
|
|
Vascular disorders
Flushing
|
4.8%
1/21 • Number of events 1 • Overall study, 14 days (treatment period)
|
|
Gastrointestinal disorders
Nausea
|
4.8%
1/21 • Number of events 1 • Overall study, 14 days (treatment period)
|
|
Gastrointestinal disorders
Vomiting
|
4.8%
1/21 • Number of events 1 • Overall study, 14 days (treatment period)
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
4.8%
1/21 • Number of events 1 • Overall study, 14 days (treatment period)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
4.8%
1/21 • Number of events 1 • Overall study, 14 days (treatment period)
|
|
Skin and subcutaneous tissue disorders
Rash
|
4.8%
1/21 • Number of events 1 • Overall study, 14 days (treatment period)
|
|
Renal and urinary disorders
Dysuria
|
4.8%
1/21 • Number of events 1 • Overall study, 14 days (treatment period)
|
|
Renal and urinary disorders
Pollakiuria
|
4.8%
1/21 • Number of events 1 • Overall study, 14 days (treatment period)
|
|
General disorders
Oedema peripheral
|
4.8%
1/21 • Number of events 1 • Overall study, 14 days (treatment period)
|
|
General disorders
Pyrexia
|
4.8%
1/21 • Number of events 1 • Overall study, 14 days (treatment period)
|
|
Investigations
White blood cell count decreased
|
4.8%
1/21 • Number of events 1 • Overall study, 14 days (treatment period)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
4.8%
1/21 • Number of events 1 • Overall study, 14 days (treatment period)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place