Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Syneos Health | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the safety and tolerability of different doses of sublingual tablets of house dust mite (HDM) allergen extracts in adolescents with house dust mite-associated allergic rhinitis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 500 IR | Experimental | 500 IR house dust mites allergen extract tablet |
|
| 1000 IR | Experimental | 1000 IR house dust mites allergen extract tablet |
|
| 1500 IR | Experimental | 1500 IR house dust mites allergen extract tablet |
|
| Placebo | Placebo Comparator | Placebo tablet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 500 IR house dust mites allergen extract tablet | Biological | One sublingual tablet daily during 10 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and Tolerability Evaluated on Treatment Emergent Adverse Events | Safety and tolerability evaluated on the number of participants who reported at least one treatment-emergent adverse event (TEAE) | 10 dosing treatment days |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Emergent Serious Adverse Events | Treatment emergent Serious Adverse Events | 10 dosing treatment days |
| Adverse Events Leading to Study Withdrawal | Incidence of adverse events leading to study withdrawal |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Piyush Patel, MD | Inflamax Research Incorporated | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Inflamax Research Inc. | Mississauga | Ontario | L4W 1N2 | Canada |
Not provided
First Patient First Visit 29 JUL 2013, Last Patient Last Visit 30 SEP 2013
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 500 IR | 500 IR house dust mites allergen extract tablet 500 IR house dust mites allergen extract tablet: One sublingual tablet daily during 10 days |
| FG001 | 1000 IR | 1000 IR house dust mites allergen extract tablet 1000 IR house dust mites allergen extract tablet: Two sublingual tablets daily during 10 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 1000 IR house dust mites allergen extract tablet | Biological | Two sublingual tablets daily during 10 days |
|
|
| 1500 IR house dust mites allergen extract tablet | Biological | Three sublingual tablets daily during 10 days |
|
|
| Placebo tablet | Biological | One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets |
|
|
| 10 dosing treatment days |
| FG002 | 1500 IR | 1500 IR house dust mites allergen extract tablet 1500 IR house dust mites allergen extract tablet: Three sublingual tablets daily during 10 days |
| FG003 | Placebo | Placebo tablet Placebo tablet: One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Safety Set: All patients who received at least one dose of treatment including those who did not complete the study were included in the Safety Set.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 500 IR | 500 IR house dust mites allergen extract tablet 500 IR house dust mites allergen extract tablet: One sublingual tablet daily during 10 days |
| BG001 | 1000 IR | 1000 IR house dust mites allergen extract tablet 1000 IR house dust mites allergen extract tablet: Two sublingual tablets daily during 10 days |
| BG002 | 1500 IR | 1500 IR house dust mites allergen extract tablet 1500 IR house dust mites allergen extract tablet: Three sublingual tablets daily during 10 days |
| BG003 | Placebo | Placebo tablet Placebo tablet: One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| 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 | Safety and Tolerability Evaluated on Treatment Emergent Adverse Events | Safety and tolerability evaluated on the number of participants who reported at least one treatment-emergent adverse event (TEAE) | Safety Set: All patients who received at least one dose of treatment including those who did not complete the study were included in the Safety Set. | Posted | Number | participants | 10 dosing treatment days |
|
|
| |||||||||||||||||||||||||||||||||||
| Secondary | Treatment Emergent Serious Adverse Events | Treatment emergent Serious Adverse Events | Posted | Number | participants | 10 dosing treatment days |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Adverse Events Leading to Study Withdrawal | Incidence of adverse events leading to study withdrawal | Posted | Number | participants | 10 dosing treatment days |
|
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 500 IR | 500 IR house dust mites allergen extract tablet 500 IR house dust mites allergen extract tablet: One sublingual tablet daily during 10 days | 0 | 9 | 4 | 9 | ||
| EG001 | 1000 IR | 1000 IR house dust mites allergen extract tablet 1000 IR house dust mites allergen extract tablet: Two sublingual tablets daily during 10 days | 0 | 9 | 6 | 9 | ||
| EG002 | 1500 IR | 1500 IR house dust mites allergen extract tablet 1500 IR house dust mites allergen extract tablet: Three sublingual tablets daily during 10 days | 0 | 9 | 9 | 9 | ||
| EG003 | Placebo | Placebo tablet Placebo tablet: One, two or three sublingual placebo tablets daily during 10 days matching with the sublingual immunotherapy tablets | 0 | 10 | 4 | 10 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Dry throat | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Oral pruritus | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Lip pruritus | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Oedema mouth | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Lip oedema | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Tongue disorder | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Tongue eruption | Gastrointestinal disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Ear pruritus | Ear and labyrinth disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Conjunctivitis allergic | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Ocular hyperaemia | Eye disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Excoriation | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
| |
| Laceration | Injury, poisoning and procedural complications | MedDRA version 16.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 16.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA version 16.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA version 16.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michel Roux, Medical Director | Stallergenes | +33 (0) 1 55 59 20 00 | mroux@stallergenes.com |
| ID | Term |
|---|---|
| D063729 | Sublingual Immunotherapy |
| ID | Term |
|---|---|
| D003888 | Desensitization, Immunologic |
| D007165 | Immunosuppression Therapy |
| D007167 | Immunotherapy |
| D056747 | Immunomodulation |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D007158 | Immunologic Techniques |
| D008919 | Investigative Techniques |
Not provided
Not provided
| Male |
|
|
|