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| ID | Type | Description | Link |
|---|---|---|---|
| MK-7243-001 | Other Identifier | Merck Protocol ID |
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This is a study to evaluate the efficacy and safety of grass sublingual tablet (SCH 697243) versus placebo in the treatment of grass pollen-induced allergic hayfever symptoms. Participants will receive either the sublingual grass tablet or a placebo tablet during the study. It is expected that those participants receiving the active sublingual grass tablet will have less hayfever symptoms and need less medications to treat hayfever symptoms during the grass pollen season.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCH 697243 | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Grass (Phleum pratense) pollen allergen extract | Biological | One dissolving tablet sublingually once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS) | The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications. For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis. | Entire GPS (expected average duration of 5 to 6 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Average Rhinoconjunctivitis DSS Over the Entire GPS | For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. |
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Inclusion Criteria:
Screening
- Safety laboratory tests and vital signs conducted at the Screening Visit must be within normal
limits or clinically acceptable to the investigator/sponsor
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24468255 | Result | Maloney J, Bernstein DI, Nelson H, Creticos P, Hebert J, Noonan M, Skoner D, Zhou Y, Kaur A, Nolte H. Efficacy and safety of grass sublingual immunotherapy tablet, MK-7243: a large randomized controlled trial. Ann Allergy Asthma Immunol. 2014 Feb;112(2):146-153.e2. doi: 10.1016/j.anai.2013.11.018. Epub 2013 Dec 21. | |
| 26507709 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | SCH 697243 | Participants receiving Grass (Phleum pratense) Pollen Allergen Extract |
| FG001 | Placebo | Participants receiving Placebo |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SCH 697243 | Participants receiving Grass (Phleum pratense) Pollen Allergen Extract |
| BG001 | Placebo | Participants receiving Placebo |
| 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 | Average Total Combined Rhinoconjunctivitis Daily Symptom Score (DSS) and Rhinoconjunctivitis Daily Medication Score (DMS) Over the Entire Grass Pollen Season (GPS) | The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications. For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis. | The Full Analysis Set (FAS) population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint. | Posted | Median | Full Range | score on a scale | Entire GPS (expected average duration of 5 to 6 weeks) |
Adverse event data were collected for up to 30 days after last dose of study drug (up to a total of 31 weeks).
The Safety Population consisted of all randomized participants who received at least one dose of study treatment. Three randomized participants never received study drug and two participants were randomized to receive Placebo but actually received SCH 697243 instead.
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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 697243 | Participants receiving Grass (Phleum pratense) Pollen Allergen Extract |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pericarditis | Cardiac disorders | MedDRA 15.0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ear pruritus | Ear and labyrinth disorders | MedDRA 15.0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012221 | Rhinitis, Allergic, Perennial |
| D003231 | Conjunctivitis |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| Placebo for SCH 697243 | Biological | One dissolving tablet sublingually once daily |
|
| Entire GPS (expected average duration of 5 to 6 weeks) |
| Average Total Combined Rhinoconjunctivitis DSS and Rhinoconjunctivitis DMS Over the Peak GPS | The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications. For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis. | Peak GPS (expected average duration of 2 weeks) |
| Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities for Participants ≥12 Years of Age (RQLQ12+) Over the Peak GPS | The RQLQ12+ consists of 7 domains: Activities, Sleep, Non-Nose/Eye Symptoms, Practical Problems, Nasal Symptoms, Eye Symptoms, Emotional. Participants reflect on their experience over the previous 7 days and assess 28 items on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0-6 [mean of all domain scores]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis. | Peak GPS (expected average duration of 2 weeks) |
| Average Rhinoconjunctivitis DMS Over the Entire GPS | For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis. | Entire GPS (expected average duration of 5 to 6 weeks) |
| Average Rhinoconjunctivitis DSS Over the Peak GPS | For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. | Peak GPS (expected average duration of 2 weeks) |
| Average Rhinoconjunctivitis DMS Over the Peak GPS | For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis. | Peak GPS (expected average duration of 2 weeks) |
| Average Paediatric Standardised Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score Over the Peak GPS (Participants 6 to <12 Years of Age) | For PRQLQ, participants assessed a total of 19 items within 5 domains: Nose Symptoms, Eye Symptoms, Practical Problems, Activity Limitation and Other Symptoms, each on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0 to 6 [mean of all domain scores]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis. | Peak GPS (expected average duration of 2 weeks) |
| Nolte M, Barber D, Maloney J, Li Z, Kaur A, Galan A, Andersen JS, Nolte H. Timothy specific IgE levels are associated with efficacy and safety of timothy grass sublingual immunotherapy tablet. Ann Allergy Asthma Immunol. 2015 Dec;115(6):509-515.e2. doi: 10.1016/j.anai.2015.09.018. Epub 2015 Oct 21. |
| 25685162 | Derived | Hebert J, Blaiss M, Waserman S, Kim H, Creticos P, Maloney J, Kaur A, Li Z, Nelson H, Nolte H. The efficacy and safety of the Timothy grass allergy sublingual immunotherapy tablet in Canadian adults and children. Allergy Asthma Clin Immunol. 2014 Oct 30;10(1):53. doi: 10.1186/1710-1492-10-53. eCollection 2014. |
| Withdrawal by Subject |
|
| Protocol Violation |
|
| Administrative |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Gender | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | SCH 697243 | Participants receiving Grass (Phleum pratense) Pollen Allergen Extract |
| OG001 | Placebo | Participants receiving Placebo |
|
|
|
| Secondary | Average Rhinoconjunctivitis DSS Over the Entire GPS | For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. | The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint. | Posted | Median | Full Range | score on a scale | Entire GPS (expected average duration of 5 to 6 weeks) |
|
|
|
|
| Secondary | Average Total Combined Rhinoconjunctivitis DSS and Rhinoconjunctivitis DMS Over the Peak GPS | The total combined score was the sum of the rhinoconjunctivitis DSS and rhinoconjunctivitis DMS for the entire GPS (total score range: 0 to 54), with a lower score representing less rhinoconjunctivitis symptoms and use of medications. For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis. | The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint. | Posted | Median | Full Range | score on a scale | Peak GPS (expected average duration of 2 weeks) |
|
|
|
|
| Secondary | Average Rhinoconjunctivitis Quality of Life Questionnaire With Standardized Activities for Participants ≥12 Years of Age (RQLQ12+) Over the Peak GPS | The RQLQ12+ consists of 7 domains: Activities, Sleep, Non-Nose/Eye Symptoms, Practical Problems, Nasal Symptoms, Eye Symptoms, Emotional. Participants reflect on their experience over the previous 7 days and assess 28 items on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0-6 [mean of all domain scores]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis. | The FAS population consisted of all randomized participants ≥12 years of age who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint. | Posted | Median | Full Range | score on a scale | Peak GPS (expected average duration of 2 weeks) |
|
|
|
|
| Secondary | Average Rhinoconjunctivitis DMS Over the Entire GPS | For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis. | The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint. | Posted | Mean | Standard Error | score on a scale | Entire GPS (expected average duration of 5 to 6 weeks) |
|
|
|
|
| Secondary | Average Rhinoconjunctivitis DSS Over the Peak GPS | For rhinoconjunctivitis DSS, participants assessed a total of 6 rhinoconjunctivitis symptoms (runny nose, blocked nose, sneezing, itchy nose, gritty feeling/red/itchy eyes, and watery eyes) each on a scale of 0 to 3 (0=no symptoms, 1=mild symptoms, 2=moderate symptoms, 3=severe symptoms; score range: 0 to 18), with a lower score representing less rhinoconjunctivitis symptoms. | The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint. | Posted | Median | Full Range | score on a scale | Peak GPS (expected average duration of 2 weeks) |
|
|
|
|
| Secondary | Average Rhinoconjunctivitis DMS Over the Peak GPS | For rhinoconjunctivitis DMS, participants reported their use of specific rescue medications with specific scores assigned to each medication (score range: 0 to 36), with a lower score representing less use of medications for rhinoconjunctivitis. | The FAS population consisted of all randomized participants who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint. | Posted | Mean | Standard Error | score on a scale | Peak GPS (expected average duration of 2 weeks) |
|
|
|
|
| Secondary | Average Paediatric Standardised Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ) Overall Score Over the Peak GPS (Participants 6 to <12 Years of Age) | For PRQLQ, participants assessed a total of 19 items within 5 domains: Nose Symptoms, Eye Symptoms, Practical Problems, Activity Limitation and Other Symptoms, each on a scale of 0 to 6 (0=Not troubled, 6=Extremely troubled; score range: 0 to 6 [mean of all domain scores]), with a higher score indicating more significant impairment due to seasonal allergic rhinoconjunctivitis. | The FAS population consisted of all randomized participants <12 years of age who received at least one dose of study drug and had at least one post-treatment observation for the analysis endpoint.entry. | Posted | Median | Full Range | score on a scale | Peak GPS (expected average duration of 2 weeks) |
|
|
|
|
| 14 |
| 753 |
| 480 |
| 753 |
| EG001 | Placebo | Participants receiving Placebo | 9 | 745 | 316 | 745 |
| Death | General disorders | MedDRA 15.0 |
|
| Appendicitis | Infections and infestations | MedDRA 15.0 |
|
| Diverticulitis | Infections and infestations | MedDRA 15.0 |
|
| Pelvic abscess | Infections and infestations | MedDRA 15.0 |
|
| Viral myocarditis | Infections and infestations | MedDRA 15.0 |
|
| Femur fracture | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Foot fracture | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Jaw fracture | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Meniscus lesion | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA 15.0 |
|
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 15.0 |
|
| Intervertebral disc degeneration | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Synovitis | Musculoskeletal and connective tissue disorders | MedDRA 15.0 |
|
| Malignant melanoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 |
|
| Uterine leiomyoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 15.0 |
|
| Syncope | Nervous system disorders | MedDRA 15.0 |
|
| Abortion spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA 15.0 |
|
| Pelvic adhesions | Reproductive system and breast disorders | MedDRA 15.0 |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
|
| Leukocytoclastic vasculitis | Skin and subcutaneous tissue disorders | MedDRA 15.0 |
|
| Deep vein thrombosis | Vascular disorders | MedDRA 15.0 |
|
| Venous thrombosis | Vascular disorders | MedDRA 15.0 |
|
| Lip swelling | Gastrointestinal disorders | MedDRA 15.0 |
|
| Oedema mouth | Gastrointestinal disorders | MedDRA 15.0 |
|
| Oral pruritus | Gastrointestinal disorders | MedDRA 15.0 |
|
| Paraesthesia oral | Gastrointestinal disorders | MedDRA 15.0 |
|
| Tongue pruritus | Gastrointestinal disorders | MedDRA 15.0 |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.0 |
|
| Upper respiratory tract infection | Infections and infestations | MedDRA 15.0 |
|
| Headache | Nervous system disorders | MedDRA 15.0 |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
|
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
|
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
|
| Throat irritation | Respiratory, thoracic and mediastinal disorders | MedDRA 15.0 |
|
The investigator agrees to provide to the SPONSOR 45 days prior to submission for publication or presentation, review copies of abstracts or manuscripts for publication that report any results of the trial.
| D012130 |
| Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |