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| ID | Type | Description | Link |
|---|---|---|---|
| 2013-002931-25 | EudraCT Number |
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This is randomized, double-blind, placebo-controlled study to test whether VLY-686 can reduce chronic pruritus in subjects with treatment-resistant pruritus associated with atopic dermatitis in comparison with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VLY-686 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VLY-686 | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity. | Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left end point was marked "no itch" (0 mm) and in the right end point was marked "worst imaginable itch" (100 mm). | 28 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanda Investigational Site | Düsseldorf | 40225 | Germany | |||
| Vanda Investigational Site |
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| ID | Title | Description |
|---|---|---|
| FG000 | VLY-686 | VLY-686 |
| FG001 | Placebo | Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | VLY-686 | VLY-686 |
| BG001 | Placebo | Placebo |
| BG002 |
| 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 | Change From Baseline to Endpoint (Day 28 or Early Termination) in Visual Analogue Scale (VAS) Pruritus 24 Hour Average Intensity. | Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left end point was marked "no itch" (0 mm) and in the right end point was marked "worst imaginable itch" (100 mm). | Posted | Least Squares Mean | Standard Error | mm | 28 days |
|
|
All Adverse Events (AEs) were collected from signature of the informed consent through study completion (approximately 63 days) regardless of seriousness or relationship to investigational product.
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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 | VLY-686 | VLY-686 | 0 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 16.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vanda Pharmaceuticals Inc. | Vanda Pharmaceuticals Inc. | 202-734-3400 | clinicaltrials@vandapharma.com |
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| ID | Term |
|---|---|
| D011537 | Pruritus |
| D003876 | Dermatitis, Atopic |
| ID | Term |
|---|---|
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C527551 | LY686017 |
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|
| Hamburg |
| 22083 |
| Germany |
| Vanda Investigational Site | Jena | 07740 | Germany |
| Vanda Investigational Site | Kiel | 24105 | Germany |
| Vanda Investigational Site | Münster | 48147 | Germany |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Pruritus 24 hours average intensity Visual Analogue Scale (VAS) at baseline | Responses were measured on a 100-mm Visual Analogue Scale (VAS), where the left end point was marked "no itch" (0 mm) and in the right end point was marked "worst imaginable itch" (100 mm). | Mean | Standard Deviation | units on a scale |
|
| Counts |
|---|
| Participants |
|
|
| 34 |
| 0 |
| 34 |
| 12 |
| 34 |
| EG001 | Placebo | Placebo | 0 | 34 | 0 | 34 | 11 | 34 |
| Fatigue | General disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Respiratory, thoracic and mediastinal disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
| Skin burning sensation | Skin and subcutaneous tissue disorders | MedDRA 16.1 | Non-systematic Assessment |
|
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| D013568 | Pathological Conditions, Signs and Symptoms |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |