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| ID | Type | Description | Link |
|---|---|---|---|
| MK-3641-004 | Other Identifier | Merck |
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The purpose of this study was to assess the safety and tolerability of a ragweed allergy immunotherapy tablet (AIT) administered sublingually (under-the tongue) in subjects 50 years of age and older with ragweed-induced rhinoconjunctivitis, with or without asthma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Matching placebo tablet sublingual, once daily |
|
| SCH 39641 6 Amb a 1-U | Experimental | 6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an AIT, sublingual, once daily |
|
| SCH 39641 12 Amb a 1-U | Experimental | 12 Amb a 1-U in an AIT, sublingual, once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo sublingual tablet, once daily |
| |
| SCH 39641 |
| Measure | Description | Time Frame |
|---|---|---|
| The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs) | Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion 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 42 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants Reporting Oral Pruritus | Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with oral pruritus were reported. | Up to Day 42 |
| Proportion 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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Due to non-compliance with Good Clinical Practice (GCP) 7 randomized participants who completed treatment were excluded from all subsequent analysis.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Matching placebo tablet sublingual, once daily |
| FG001 | SCH 39641 6 Amb a 1-U | 6 Units Short Ragweed (Ambrosia artemisiifolia) Major Allergen 1 (Amb a 1-U) in an Allergy Immunotherapy Tablet (AIT) sublingual, once daily |
| FG002 | SCH 39641 12 Amb a 1-U | 12 Amb a 1-U in an AIT, sublingual, once daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Matching placebo tablet sublingual, once daily |
| BG001 | SCH 39641 6 Amb a 1-U | 6 Amb a 1-U in an AIT, 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 | The Proportion of Participants Reporting Treatment-emergent Adverse Events (AEs) | Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion 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 all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis. | Posted | Number | Proportion of Participants | Up to Day 42 |
|
Up to Day 42
ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis.
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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 | Placebo | Matching placebo tablet sublingual, once daily |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis acute | Hepatobiliary disorders | MedDRA 13.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pruritus | Ear and labyrinth disorders | MedDRA 13.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
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| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D003231 | Conjunctivitis |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Biological |
Allergy immunotherapy tablet (sublingual) |
|
|
| SCH 39641 | Biological | Allergy immunotherapy tablet (sublingual) |
|
|
Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with ear pruritus were reported. |
| Up to Day 42 |
| Proportion of Participants Reporting Throat Irritation | Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with throat irritation were reported. | Up to Day 42 |
| Proportion of Participants Reporting Mouth Oedema | Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with mouth oedema were reported. | Up to Day 42 |
| Proportion of Participants Who Discontinued Due to Adverse Events. | Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with AEs leading to study discontinuation were reported. 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. | Up to Day 28 |
| Protocol Violation |
|
| BG002 | SCH 39641 12 Amb a 1-U | 12 Amb a 1-U in an AIT, sublingual, once daily |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Gender | Count of Participants | Participants |
|
Matching placebo tablet sublingual, once daily
| OG001 | SCH 39641 6 Amb a 1-U | 6 Amb a 1-U in an AIT, sublingual, once daily |
| OG002 | SCH 39641 12 Amb a 1-U | 12 Amb a 1-U in an AIT, sublingual, once daily |
|
|
|
| Secondary | Proportion of Participants Reporting Oral Pruritus | Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with oral pruritus were reported. | ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis. | Posted | Number | Proportion of Participants | Up to Day 42 |
|
|
|
| Secondary | Proportion of Participants Reporting Ear Pruritus | Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with ear pruritus were reported. | ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis. | Posted | Number | Proportion of Participants | Up to Day 42 |
|
|
|
| Secondary | Proportion of Participants Reporting Throat Irritation | Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with throat irritation were reported. | ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis. | Posted | Number | Proportion of Participants | Up to Day 42 |
|
|
|
| Secondary | Proportion of Participants Reporting Mouth Oedema | Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with mouth oedema were reported. | ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis. | Posted | Number | Proportion of Participants | Up to Day 42 |
|
|
|
| Secondary | Proportion of Participants Who Discontinued Due to Adverse Events. | Participants were treated for 28 days with either 6 or 12 Units of SCH 39641 or placebo, and the proportion with AEs leading to study discontinuation were reported. 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. | ASAT consisting of all randomized participants who received at least one dose of study treatment. Due to non-compliance with GCP 7 participants were excluded from this analysis. | Posted | Number | Proportion of Participants | Up to Day 28 |
|
|
|
| 0 |
| 65 |
| 11 |
| 65 |
| EG001 | SCH 39641 6 Amb a 1-U | 6 Amb a 1-U in an AIT, sublingual, once daily | 0 | 66 | 23 | 66 |
| EG002 | SCH 39641 12 Amb a 1-U | 12 Amb a 1-U in an AIT, sublingual, once daily | 1 | 65 | 23 | 65 |
| Post procedural bile leak | Injury, poisoning and procedural complications | MedDRA 13.0 | Systematic Assessment |
|
| Eye pruritus | Eye disorders | MedDRA 13.0 | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Hypoaesthesia oral | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
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| Oral pruritus | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 13.0 | Systematic Assessment |
|
The investigator agrees to provide to the sponsor for review 45 days prior to submission for publication or presentation, copies of abstracts or manuscripts for publication 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, in order to make good faith efforts to discuss and resolve any issues or disagreements.
| D010038 |
| Otorhinolaryngologic Diseases |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D007154 | Immune System Diseases |