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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GK567 | Experimental | GK567: Metronidazole Gel 0.75% Once or twice daily, for 14 days, up to 30g |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GK567 | Drug | Once or twice daily, for 14 days, up to 30 g per day |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at Day 14 (end of treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | on Days 0 (baseline), 7, and 14 |
| Smell Score by Nurse |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Galderma investigational site | Kanagawa | Japan | ||||
| Galderma investigational site |
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April 2012 to December 2012 in Japan
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| ID | Title | Description |
|---|---|---|
| FG000 | GK567 | Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses.
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| ID | Title | Description |
|---|---|---|
| BG000 | GK567 | Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30g |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | 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. | Posted | Number | 90% Confidence Interval | percentage of participants | at Day 14 (end of treatment) |
|
Overall study, 14 days (treatment period)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | GK567 | Metronidazole Gel 0.75%, Once or twice daily, for 14 days, up to 30 g |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin neoplasm bleeding | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Project Manager | Galderma K.K. | +81 3 5937 3850 | GaldermaKK.ClinDev@galderma.com |
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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 |
| on Days 0 (baseline), 7, and 14 |
| 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 | on Days 0 (baseline), 7, and 14 |
| 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). | on Days 0 (baseline), 7, and 14 |
| 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). | on Days 0 (baseline), 7, and 14 |
| Tokyo |
| Japan |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Primary Disease | Number | participants |
|
| Skin Ulcer Size | Mean | Standard Deviation | cm^2 |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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 | All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses. | Posted | Number | participants | on Days 0 (baseline), 7, and 14 |
|
|
|
| Secondary | 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 | All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses. | Posted | Number | participants | on Days 0 (baseline), 7, and 14 |
|
|
|
| Secondary | 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 | All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses. | Posted | Number | participants | on Days 0 (baseline), 7, and 14 |
|
|
|
| Secondary | 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). | All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses. | Posted | Number | participants | on Days 0 (baseline), 7, and 14 |
|
|
|
| Secondary | 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). | All patients who received the treatment at least once (Safety population) were included in all efficacy and safety analyses. | Posted | Mean | Standard Deviation | mm | on Days 0 (baseline), 7, and 14 |
|
|
|
| 1 |
| 21 |
| 14 |
| 21 |
| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Fatigue | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Gamma-glutamyltransferase increased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Anaemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA 15.0 | Systematic Assessment |
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| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Hepatic function abnormal | Hepatobiliary disorders | MedDRA 15.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| Pollakiuria | Renal and urinary disorders | MedDRA 15.0 | Systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 15.0 | Systematic Assessment |
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| Pyrexia | General disorders | MedDRA 15.0 | Systematic Assessment |
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| White blood cell count decreased | Investigations | MedDRA 15.0 | Systematic Assessment |
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| Procedural pain | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
|
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| 2: Mildly offensive smell |
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| 3: Moderately offensive smell |
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| 4: Extremely offensive smell |
|
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| 2: Mildly offensive smell |
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| 3: Moderately offensive smell |
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| 4: Extremely offensive smell |
|
|
| 2: Mildly offensive smell |
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| 3: Moderately offensive smell |
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| 4: Extremely offensive smell |
|
| Title | Measurements |
|---|---|
|
| 2 Moderate |
|
| 3 Marked |
|