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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3641 | Other Identifier | Merck |
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This study assessed the safety profile of short ragweed (Ambrosia artemisiifolia) in participants with ragweed-induced rhinoconjunctivitis with or without asthma. The primary objective was to compare treatment-emergent adverse events (AEs) for participants treated with short ragweed allergy immunotherapy tablet (AIT) with those treated with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCH 39641 12 Amb a 1-U | Experimental | 12 Units short ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) extract in an AIT, sublingual, once daily. |
|
| Placebo | Placebo Comparator | Matching placebo tablet, sublingual, once daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCH 39641 | Biological | Rapidly dissolving tablet sublingually once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (AEs) | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization. | Up to Day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Reporting Oral Pruritus. | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with oral pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | Up to Day 35 |
| Number of Participants Reporting Ear Pruritus |
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Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24836393 | Derived | Nolte H, Amar N, Bernstein DI, Lanier BQ, Creticos P, Berman G, Kaur A, Hebert J, Maloney J. Safety and tolerability of a short ragweed sublingual immunotherapy tablet. Ann Allergy Asthma Immunol. 2014 Jul;113(1):93-100.e3. doi: 10.1016/j.anai.2014.04.018. Epub 2014 May 14. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SCH 39641 12 Amb a 1-U | 12 Units short ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) extract in an allergy immunotherapy tablet (AIT), sublingual, once daily. |
| FG001 | Placebo | Matching placebo tablet, sublingual, once daily. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SCH 39641 12 Amb a 1-U | 12 Amb a 1-U extract in an AIT, sublingual, once daily. |
| BG001 | Placebo | Matching placebo tablet, sublingual, once daily. |
| 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 | Number of Participants With Treatment-emergent Adverse Events (AEs) | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with treatment-emergent AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization. | All subjects as treated (ASAT) consisting of participants who received at least one dose of study treatment | Posted | Number | Participants | Up to Day 35 |
|
Up to Day 35
ASAT population consisting of participants who received at least one dose of study treatment. Treatment-emergent AEs are reported.
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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 | SCH 39641 12 Amb a 1-U | 12 Amb a 1-U extract in an AIT, sublingual, once daily. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Haemorrhagic anemia | Blood and lymphatic system disorders | MedDRA 15.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pruritus | Ear and labyrinth disorders | MedDRA 15.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| Placebo for SCH 39641 | Drug | Rapidly dissolving tablet sublingually once daily |
|
Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with ear pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. |
| Up to Day 35 |
| Number of Participants Reporting Throat Irritation | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with throat irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | Up to Day 35 |
| Number of Participants Reporting Mouth Oedema | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with mouth oedema were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | Up to Day 35 |
| Number of Participants Reporting Eye Pruritus | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with eye pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | Up to Day 35 |
| Number of Participants Reporting Nasal Passage Irritation | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with nasal passage irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | Up to Day 35 |
| Number of Participants Reporting Skin Pruritus | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with skin pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | Up to Day 35 |
| Number of Participants Who Discontinued Due to Treatment-emergent AEs | Participants were treated with either SCH 39641 12 Amb a 1-U or placebo for 28 days, and the number who discontinued due to treatment emergent-AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization. | Up to Day 28 |
| Withdrawal by Subject |
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| Protocol Violation |
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| Did not meet Protocol Eligibility |
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| BG002 | Total | Total of all reporting groups |
| Years |
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| Gender | Count of Participants | Participants |
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| OG001 | Placebo | Matching placebo tablet, sublingual, once daily. |
|
|
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| Secondary | Number of Participants Reporting Oral Pruritus. | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with oral pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | ASAT consisting of participants who received at least one dose of study treatment | Posted | Number | Participants | Up to Day 35 |
|
|
|
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| Secondary | Number of Participants Reporting Ear Pruritus | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with ear pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | ASAT consisting of participants who received at least one dose of study treatment | Posted | Number | Participants | Up to Day 35 |
|
|
|
|
| Secondary | Number of Participants Reporting Throat Irritation | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with throat irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | ASAT consisting of participants who received at least one dose of study treatment | Posted | Number | Participants | Up to Day 35 |
|
|
|
|
| Secondary | Number of Participants Reporting Mouth Oedema | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with mouth oedema were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | ASAT consisting of participants who received at least one dose of study treatment | Posted | Number | Participants | Up to Day 35 |
|
|
|
|
| Secondary | Number of Participants Reporting Eye Pruritus | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with eye pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | ASAT consisting of participants who received at least one dose of study treatment | Posted | Number | Participants | Up to Day 35 |
|
|
|
|
| Secondary | Number of Participants Reporting Nasal Passage Irritation | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with nasal passage irritation were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | ASAT consisting of participants who received at least one dose of study treatment | Posted | Number | Participants | Up to Day 35 |
|
|
|
|
| Secondary | Number of Participants Reporting Skin Pruritus | Participants were treated for 28 days with either SCH 39641 12 Amb a 1-U or placebo, and the number with skin pruritus were recorded. All AEs, combining non-treatment-emergent AEs with treatment-emergent AEs, were reported. | ASAT consisting of participants who received at least one dose of study treatment | Posted | Number | Participants | Up to Day 35 |
|
|
|
|
| Secondary | Number of Participants Who Discontinued Due to Treatment-emergent AEs | Participants were treated with either SCH 39641 12 Amb a 1-U or placebo for 28 days, and the number who discontinued due to treatment emergent-AEs were recorded. An AE is any unfavorable and unintended sign, symptom or disease temporarily associated with the use of a medicinal product, whether or not considered related to the medicinal product. Treatment-emergent AEs are new AEs that occur after participants have been randomized into the trial, or existing AEs that occurred during Screening that increase in severity after randomization. | ASAT consisting of participants who received at least one dose of study treatment | Posted | Number | Participants | Up to Day 28 |
|
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|
|
| 1 |
| 609 |
| 199 |
| 609 |
| EG001 | Placebo | Matching placebo tablet, sublingual, once daily. | 3 | 304 | 57 | 304 |
| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA 15.0 | Systematic Assessment |
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| Arthritis bacterial | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Fibula fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Tibia fracture | Injury, poisoning and procedural complications | MedDRA 15.0 | Systematic Assessment |
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| Henoch-schonlein purpura | Skin and subcutaneous tissue disorders | MedDRA 15.0 | Systematic Assessment |
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| Thrombophlebitis superficial | Vascular disorders | MedDRA 15.0 | Systematic Assessment |
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| Oedema mouth | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Oral pruritus | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Paraesthesia oral | Gastrointestinal disorders | MedDRA 15.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA 15.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 15.0 | Systematic Assessment |
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| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 | Systematic Assessment |
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The investigator agrees to provide to the sponsor for review 45 days prior to submission for publication or presentation copies of abstracts or manuscripts that report any results of the trial. If the parties disagree concerning the sponsor's confidential information the investigator agrees to meet with the sponsor's representative, prior to submission for publication, to discuss and resolve any issues or disagreement.