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| ID | Type | Description | Link |
|---|---|---|---|
| CL2008-15 | |||
| P07530 | Other Identifier | Merck |
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This is a randomized, two-way crossover, multicenter study evaluating the consumer preference of Phenylephrine Extended Release Tablets, 30 mg to be taken as one tablet every 12 hours, or Phenylephrine Immediate Release Tablets, 10 mg to be taken as one tablet every 4 hours in subjects with at least mild allergic rhinitis and nasal congestion. Approximately 250 participants will complete a questionnaire after taking one test product for 3 days followed by a 3 day (± 1 day) washout period; and then taking the alternate test product for 3 days. Analysis of which product the consumer preferred, if any, and which product was more convenient, if any, will be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Phenylephrine Hydrochloride Extended Release Tablets, 30 mg | Experimental |
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| Phenylephrine Hydrochloride Immediate Release Tablets, 10 mg | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phenylephrine Hydrochloride (HCl) Extended Release (ER) Tablets 30 mg | Drug | Phenylephrine HCl ER tablets 30 mg taken every 12 hours, twice daily, for 3 days. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants That Preferred Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets for the Relief of Nasal Congestion | Preference was calculated based on total participants that completed the study. Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints: Which product, if any, did you prefer for the relief of nasal congestion? The possible answers were:
or • I did not have a preference | Visit 6 (Period 2, Day 4) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants That Preferred the Convenience of Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets | Convenience was calculated based on total participants that completed the study. Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints: Secondary Endpoint Which product, if any, was more convenient? The possible answers were:
or • I did not have a preference |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Title | Description |
|---|---|---|
| FG000 | Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR | Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride (HCl) 30 mg Extended Release (ER) tablets every 12 hours, twice daily, for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine HCl 10 mg Immediate Release (IR) tablets, every 4 hours (no more than 6 times daily) for 3 days. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
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| Phenylephrine Hydrochloride (HCl) Immediate Release (IR) tablets, 10 mg | Drug | Phenylephrine HCl IR tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days. |
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| Visit 6 (Period 2, Day 4) |
| FG001 | Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER | Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride 10 mg Immediate Release tablets, every 4 hours (no more than 6 times daily) for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine Hydrochloride 30 mg Extended Release tablets every 12 hours, twice daily, for 3 days. |
| COMPLETED |
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| NOT COMPLETED |
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| Wash-out Period |
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| Treatment Period 2 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Phenylephrine HCl 30 ER First, Then Phenylephrine HCl 10 IR | Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride (HCl) 30 mg Extended Release (ER) tablets every 12 hours, twice daily, for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine HCl 10 mg Immediate Release (IR) tablets, every 4 hours (no more than 6 times daily) for 3 days. |
| BG001 | Phenylephrine HCl 10 IR First, Then Phenylephrine HCl 30 ER | Participants received a 5-day run in period with Loratadine 10 mg tablets until the end of the second treatment period. Participants received Phenylephrine Hydrochloride 10 mg Immediate Release tablets, every 4 hours (no more than 6 times daily) for 3 days. After a 3 day (+/- 1 day) washout period, participants were crossed over and received Phenylephrine Hydrochloride 30 mg Extended Release tablets every 12 hours, twice daily, for 3 days. |
| BG002 | Total | Total of all reporting groups |
| 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 | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| 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 | Percentage of Participants That Preferred Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets for the Relief of Nasal Congestion | Preference was calculated based on total participants that completed the study. Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints: Which product, if any, did you prefer for the relief of nasal congestion? The possible answers were:
or • I did not have a preference | A total of 319 of 331 subjects who completed both treatment periods provided a response to the primary endpoint, and hence were included in the Modified Intent-to-Treat (MITT) population. | Posted | Number | Percentage of participants | Visit 6 (Period 2, Day 4) |
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| Secondary | Percentage of Participants That Preferred the Convenience of Phenylephrine HCl 30 mg Extended Release Tablets, as Compared to Phenylephrine HCl 10 mg Immediate Release Tablets | Convenience was calculated based on total participants that completed the study. Responses to the following questions in the consumer preference questionnaire were the basis for the preference endpoints: Secondary Endpoint Which product, if any, was more convenient? The possible answers were:
or • I did not have a preference | A total of 319 of 331 subjects who completed both treatment periods provided a response to the primary endpoint, and hence were included in the Modified Intent-to-Treat (MITT) population. | Posted | Number | Percentage of participants | Visit 6 (Period 2, Day 4) |
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Participants who had taken at least one dose of treatment were included in the safety population. 7 participants discontinued (d/c) prior to receiving Phenylephrine IR 10 mg and were not included. 3 participants d/c prior to receiving Phenylephrine HCl ER 30 mg and 1 additional participant returned all medication without use and were not included.
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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 | Phenylephrine HCl ER, 30 mg | Phenylephrine Hydrochloride (HCl) Extended Release (ER) tablets 30 mg taken every 12 hours, twice daily, for 3 days. | 0 | 327 | 0 | 327 | ||
| EG001 | Phenylephrine HCl IR, 10 mg | Phenylephrine Hydrochloride (HCl) Immediate Release tablets 10 mg taken every four hours (no more than 6 times daily) for 3 days. | 0 | 324 | 0 | 324 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012223 | Rhinitis, Vasomotor |
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D065631 | Rhinitis, Allergic |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D010656 | Phenylephrine |
| D013607 | Tablets |
| D010109 | Oxymetazoline |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Protocol Violation |
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| Other |
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| Male |
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| Title | Measurements |
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| Participants |
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