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| ID | Type | Description | Link |
|---|---|---|---|
| CL2010-06 | |||
| P08156 | Other Identifier | Merck |
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The trial will evaluate the nasal congestion symptom relief of the approved 10 mg phenylephrine (PE) dose and the higher 20 mg, 30 mg, and 40 mg PE doses compared with placebo in participants with histories of seasonal allergic rhinitis, using loratadine as background medication.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PE 10 mg | Experimental |
| |
| PE 20 mg | Experimental |
| |
| PE 30 mg | Experimental |
| |
| PE 40 mg | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine HCl | Drug | 10-mg immediate-release tablets, orally, up to 4 tablets per dose every 4 hours, for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score | The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. Participants rated congestion on a 4-point scale of severity from 0 (best) to 3 (worst), with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. Baseline was defined as the average of the daily scores over the 4 consecutive 24-hour periods before randomization. | Baseline, Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | The morning reflective nasal congestion score was captured in participant diaries just before the 8:00 am dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and it is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. |
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Inclusion criteria:
Exclusion criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26143019 | Derived | Meltzer EO, Ratner PH, McGraw T. Oral Phenylephrine HCl for Nasal Congestion in Seasonal Allergic Rhinitis: A Randomized, Open-label, Placebo-controlled Study. J Allergy Clin Immunol Pract. 2015 Sep-Oct;3(5):702-8. doi: 10.1016/j.jaip.2015.05.007. Epub 2015 Jul 2. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PE 10 mg | PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment. |
| FG001 | PE 20 mg | PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment. |
| FG002 | PE 30 mg | PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment. |
| FG003 | PE 40 mg | PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment. |
| FG004 | Placebo | Matching placebo was administered orally every 4 hours in combination with background loratadine treatment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | PE 10 mg | PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment. |
| BG001 | PE 20 mg | PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | Mean Change From Baseline Over the Entire Treatment Period in the Daily Reflective Nasal Congestion Score | The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. Participants rated congestion on a 4-point scale of severity from 0 (best) to 3 (worst), with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. Baseline was defined as the average of the daily scores over the 4 consecutive 24-hour periods before randomization. | The Intent-to-Treat (ITT) population included all randomized participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, Day 7 |
|
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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 | PE 10 mg | PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest Pain | General disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D010109 | Oxymetazoline |
| D017336 | Loratadine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Drug | Placebo tablets, orally, up to five tablets per dose every 4 hours, for 7 days |
|
| Loratadine | Drug | 10-mg tablets, orally, once per day at a dose not to exceed 10 mg in a 24-hour period. |
|
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| Baseline and Days 2, 3, 4, 5, 6, and 7 |
| Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | The evening reflective nasal congestion score was captured in participant diaries just before the 8;00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. | Baseline and Days 1, 2, 3, 4, 5, 6, and 7 |
| Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. | Baseline and Day 2, 3, 4, 5, 6, and 7 |
| Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. | Baseline and Days 1, 2, 3, 4, 5, 6, and 7 |
| Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. | Baseline and Days 1, 2, 3, 4, 5, 6, and 7 |
| Time to Maximal Effect | Time to maximal effect is defined as the earliest time that the nasal congestion symptom score demonstrates the greatest numerical difference from the placebo in change from baseline. The mean change from baseline scores for a treatment arm and for the placebo arm at each day and timepoint of the treatment period (Day 1 morn, Day 1 eve, etc) were calculated. Then the difference between the placebo and treatment arm means at each day/timepoint of the treatment period was calculated and recorded the day/timepoint that the difference between the treatment arm and the placebo was highest. | Baseline up to Day 7 |
| Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7 | The magnitude of effect was measured as the change from baseline for the instantaneous nasal symptom assessment score at Day 7. Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. | Baseline, Day 7 |
| Withdrawal by Subject |
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| Lost to Follow-up |
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| Protocol Violation |
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| Unknown Reason |
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| BG002 | PE 30 mg | PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment. |
| BG003 | PE 40 mg | PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment. |
| BG004 | Placebo | Matching placebo was administered orally every 4 hours in combination with background loratadine treatment. |
| BG005 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
PE 10 mg was administered orally every 4 hours in combination with background loratadine treatment. |
| OG001 | PE 20 mg | PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment. |
| OG002 | PE 30 mg | PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment. |
| OG003 | PE 40 mg | PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment. |
| OG004 | Placebo | Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment. |
|
|
|
| Secondary | Mean Change From Baseline in the Morning (a.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | The morning reflective nasal congestion score was captured in participant diaries just before the 8:00 am dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and it is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. | The ITT population included all randomized participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Days 2, 3, 4, 5, 6, and 7 |
|
|
|
| Secondary | Mean Change From Baseline in the Evening (p.m.) Symptom Score for the Nasal Reflective Symptom Assessment by Study Day of the Treatment Period | The evening reflective nasal congestion score was captured in participant diaries just before the 8;00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. | The ITT population included all randomized participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Days 1, 2, 3, 4, 5, 6, and 7 |
|
|
|
| Secondary | Mean Change From Baseline in the a.m. Symptom Score for the Instantaneous Nasal Symptom Assessment by Study Day of the Treatment Period | Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. | The ITT population included all randomized participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Day 2, 3, 4, 5, 6, and 7 |
|
|
|
| Secondary | Mean Change From Baseline for the Daily Reflective Nasal Symptom Assessment Score by Study Day of the Treatment Period | The reflective nasal congestion score was captured in participant diaries just before the 8:00 a.m. dose and 12 hours later just before the 8:00 p.m. dose. It is a composite score including four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. The daily reflective nasal congestion symptom score was defined as the average of the morning and evening reflective nasal congestion score for the entire treatment period. | The ITT population included all randomized participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Days 1, 2, 3, 4, 5, 6, and 7 |
|
|
|
| Secondary | Mean Change From Baseline for the Instantaneous Nasal Symptom Assessment Score By Study Day of the Treatment Period | Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. | The ITT population included all randomized participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline and Days 1, 2, 3, 4, 5, 6, and 7 |
|
|
|
| Secondary | Time to Maximal Effect | Time to maximal effect is defined as the earliest time that the nasal congestion symptom score demonstrates the greatest numerical difference from the placebo in change from baseline. The mean change from baseline scores for a treatment arm and for the placebo arm at each day and timepoint of the treatment period (Day 1 morn, Day 1 eve, etc) were calculated. Then the difference between the placebo and treatment arm means at each day/timepoint of the treatment period was calculated and recorded the day/timepoint that the difference between the treatment arm and the placebo was highest. | The ITT population included all randomized participants who received at least 1 dose of study medication. | Posted | Number | Days | Baseline up to Day 7 |
|
|
|
| Secondary | Change From Baseline for the Instantaneous Nasal Symptom Assessment Score at Day 7 | The magnitude of effect was measured as the change from baseline for the instantaneous nasal symptom assessment score at Day 7. Instantaneous assessment of nasal symptoms was performed once daily before the morning dose. The instantaneous assessment was a composite score of four nasal symptoms: rhinorrhea, nasal congestion, nasal itching, and sneezing and is rated on a 0-3 scale of severity with 0 = absent symptoms, 1 = mild symptoms, 2 = moderate symptoms, and 3 = severe symptoms. | The ITT population included all randomized participants who received at least 1 dose of study medication. | Posted | Mean | Standard Deviation | Units on a Scale | Baseline, Day 7 |
|
|
|
| 0 |
| 109 |
| 6 |
| 109 |
| EG001 | PE 20 mg | PE 20 mg was administered orally every 4 hours in combination with background loratadine treatment. | 0 | 108 | 4 | 108 |
| EG002 | PE 30 mg | PE 30 mg was administered orally every 4 hours in combination with background loratadine treatment. | 0 | 107 | 3 | 107 |
| EG003 | PE 40 mg | PE 40 mg was administered orally every 4 hours in combination with background loratadine treatment. | 1 | 112 | 3 | 112 |
| EG004 | Placebo | Matching placebo tablets were administered orally every 4 hours in combination with background loratadine treatment. | 0 | 103 | 0 | 103 |
| Pain in Jaw | Musculoskeletal and connective tissue disorders |
|
The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission or publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication timelines.
| D010038 |
| Otorhinolaryngologic Diseases |
| D065631 | Rhinitis, Allergic |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D003533 |
| Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D011083 | Polycyclic Compounds |
| Day 2 (n = 104, 106, 102, 104, 101) |
|
| Day 3 (n = 104, 104, 102, 103, 101) |
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| Day 4 (n = 104, 104, 101, 102, 101) |
|
| Day 5 (n = 104, 104, 101, 100, 100) |
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| Day 6 (n = 104, 104, 100, 100, 100) |
|
| Day 7 (n = 104, 103, 100, 99, 100) |
|
| Day 1 (n = 102, 106, 101, 102, 101) |
|
| Day 2 (n = 102, 103, 102, 103, 101) |
|
| Day 3 (n = 104, 104, 101, 101, 101) |
|
| Day 4 (n = 104, 104, 101, 99, 100) |
|
| Day 5 (n = 104, 102, 97, 99, 99) |
|
| Day 6 (n = 104, 103, 100, 100, 100) |
|
| Day 7 (n = 104, 102, 100, 98, 100) |
|
| Day 2 (n = 104, 105, 102, 103, 101) |
|
| Day 3 (n = 104, 103, 102, 102, 101) |
|
| Day 4 (n = 104, 103,101,101, 101) |
|
| Day 5 (n = 104, 103, 101, 99, 101) |
|
| Day 6 (n = 104, 104, 100, 99, 100) |
|
| Day 7 (n = 104, 102, 100, 98, 100) |
|
| Day 1 (n = 102, 106, 101, 102, 101) |
|
| Day 2 (n = 104, 106, 102, 104, 101) |
|
| Day 3 (n = 104, 104, 102, 103, 101) |
|
| Day 4 (n = 104, 104, 101, 102, 101) |
|
| Day 5 (n = 104, 104, 101, 100, 101) |
|
| Day 6 (n = 104, 104, 100, 100, 100) |
|
| Day 7 (n = 104, 103, 100, 99, 100) |
|
| Day 2 (n = 102, 104, 100, 99, 100) |
|
| Day 3 (n = 102, 102, 100, 98, 100) |
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| Day 4 (n = 102, 102, 99, 97, 100) |
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| Day 5 (n = 102, 102, 99, 95, 100) |
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| Day 6 (n =102, 102, 98, 95, 100) |
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| Day 7 (n = 102, 101, 98, 94, 100) |
|