Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
In this study, researchers were primarily interested in evaluating the level of agreement of cooling sensation provided by this chewable, flavored, allergy medicine. Participants joining this study received one test drug tablet and were asked to chew completely before swallowing the drug. A questionnaire was used to collect the feedback from participants. The study involved only one (1) visit and participant stayed in this study for about 60-75 minutes to evaluate the cooling sensation as well as other sensory attributes perceived in the mouth, nose and throat.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Loratadine chewable tablet | Experimental | Participants received one dose of loratadine chewable tablet to chew completely before swallowing. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Loratadine (Claritin, BAY76-2211) | Drug | Chewable tablet, oral, single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Agreement of Perception of Cooling Sensation | Participants were asked to response to question "the product provides a cooling sensation" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation. | Up to 5 minutes post ingestion of study medication |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location | Participants were asked to respond to question "the product provides a cooling sensation in the mouth, nose or throat" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Focus Pointe Global | Teaneck | New Jersey | 07666 | United States |
Availability of this study's data will be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.clinicalstudydatarequest.com to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the Study sponsors section of the portal.
Not provided
Not provided
Not provided
Not provided
Overall, 468 participants were screened. Of them, 10 participants were screen failures and 16 participants did not complete the study with early termination. 442 participants received study treatment and completed the study.
Study was conducted at multiple centers in the US between 12 November 2019 (first participant first visit) and 13 November 2019 (last participant last visit).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Loratadine Chewable Tablet | Participants received one dose of loratadine chewable tablet to chew completely before swallowing. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All participants who received the study medication and had an evaluation data for study medication
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Loratadine Chewable Tablet | Participants received one dose of loratadine chewable tablet to chew completely before swallowing. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| 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 | Proportion of Participants With Agreement of Perception of Cooling Sensation | Participants were asked to response to question "the product provides a cooling sensation" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation. | All participants who received the study medication and had an evaluation data for study medication | Posted | Number | 95% Confidence Interval | Proportion of participants | Up to 5 minutes post ingestion of study medication |
|
From the signing of the informed consent form (ICF) until discharge from the study site (1 day)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Loratadine Chewable Tablet | Participants received one dose of loratadine chewable tablet to chew completely before swallowing. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
Kaplan-Meier Estimates of the duration of the cooling sensation were not able to be reported in this data set.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therapeutic Area Head | Bayer | 1-888-8422937 | clinical-trials-contact@bayer.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 21, 2019 | Oct 28, 2020 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
Not provided
Not provided
| ID | Term |
|---|---|
| D017336 | Loratadine |
| ID | Term |
|---|---|
| D003533 | Cyproheptadine |
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
Not provided
Not provided
Not provided
Not provided
Not provided
Participants were blinded to product brand
Not provided
| Up to 5 minutes post ingestion of study medication |
| Proportion of Participants With Agreement of Perception of Refreshing Sensation | Participants were asked to response to question "the product provides a refreshing sensation" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation. | Up to 5 minutes post ingestion of study medication |
| Proportion of Participants With Agreement of the Refreshing of the Cooling Sensation | Participants were asked to response to question "the cooling sensation is refreshing" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the refreshing of the cooling sensation. | Up to 5 minutes post ingestion of study medication |
| Proportion of Participants With Agreement of the Unique Sensory Experience for an Allergy Medicine | Participants were asked to response to question "the sensory experience is unique for an allergy medicine" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the unique sensory experience sensation. | Up to 5 minutes post ingestion of study medication |
| Proportion of Participants With Agreement of Soothing Feeling on the Throat | Participants were asked to response to question "the product feels soothing on the throat" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the soothing feeling. | Up to 5 minutes post ingestion of study medication |
| Proportion of Participants With Agreement of Liking the Flavor Sensation of the Product | Participants were asked to response to question "I like the flavor sensation of the product" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of liking the enjoyable flavor sensation. | Up to 5 minutes post ingestion of study medication |
| Proportion of Participants With Agreement of the Enjoyable Product Experience | Participants were asked to response to question "the product experience was enjoyable" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the enjoyable experience. | Up to 5 minutes post ingestion of study medication |
| Proportion of Participants With Agreement of the Great Taste of the Product | Participants were asked to response to question "the product tastes great" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the great taste. | Up to 5 minutes post ingestion of study medication |
| Time to Perception of Cooling Sensation | The mean time point at which cooling was initially perceived was claimed as the onset of cooling. The mean onsets of cooling sensation in the mouth, nose and throat were reported. | Up to 60 minutes post ingestion of study medication |
| Duration of Cooling Sensation | Participants who reported that they never experienced a cooling sensation were not included in the model. Those for whom the cooling sensation extended for 60 minutes or more were considered right-censored and were treated as such in the model. The median time of cooling sensation in the mouth, nose and throat was reported. Dispersion values were not calculated for this sensory study. | Up to 60 minutes post ingestion of study medication |
| Percentage of participants |
|
| Sex/Gender, Customized | Number | Percentage of participants |
|
| Race/Ethnicity, Customized | Number | Percentage of participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location | Participants were asked to respond to question "the product provides a cooling sensation in the mouth, nose or throat" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation. | All participants who received the study medication and had an evaluation data for study medication | Posted | Number | 95% Confidence Interval | Proportion of participants | Up to 5 minutes post ingestion of study medication |
|
|
|
| Secondary | Proportion of Participants With Agreement of Perception of Refreshing Sensation | Participants were asked to response to question "the product provides a refreshing sensation" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of perception of the sensation. | All participants who received the study medication and had an evaluation data for study medication | Posted | Number | 95% Confidence Interval | Proportion of participants | Up to 5 minutes post ingestion of study medication |
|
|
|
| Secondary | Proportion of Participants With Agreement of the Refreshing of the Cooling Sensation | Participants were asked to response to question "the cooling sensation is refreshing" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the refreshing of the cooling sensation. | All participants who received the study medication and had an evaluation data for study medication | Posted | Number | 95% Confidence Interval | Proportion of participants | Up to 5 minutes post ingestion of study medication |
|
|
|
| Secondary | Proportion of Participants With Agreement of the Unique Sensory Experience for an Allergy Medicine | Participants were asked to response to question "the sensory experience is unique for an allergy medicine" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the unique sensory experience sensation. | All participants who received the study medication and had an evaluation data for study medication | Posted | Number | 95% Confidence Interval | Proportion of participants | Up to 5 minutes post ingestion of study medication |
|
|
|
| Secondary | Proportion of Participants With Agreement of Soothing Feeling on the Throat | Participants were asked to response to question "the product feels soothing on the throat" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the soothing feeling. | All participants who received the study medication and had an evaluation data for study medication | Posted | Number | 95% Confidence Interval | Proportion of participants | Up to 5 minutes post ingestion of study medication |
|
|
|
| Secondary | Proportion of Participants With Agreement of Liking the Flavor Sensation of the Product | Participants were asked to response to question "I like the flavor sensation of the product" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of liking the enjoyable flavor sensation. | All participants who received the study medication and had an evaluation data for study medication | Posted | Number | 95% Confidence Interval | Proportion of participants | Up to 5 minutes post ingestion of study medication |
|
|
|
| Secondary | Proportion of Participants With Agreement of the Enjoyable Product Experience | Participants were asked to response to question "the product experience was enjoyable" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the enjoyable experience. | All participants who received the study medication and had an evaluation data for study medication | Posted | Number | 95% Confidence Interval | Proportion of participants | Up to 5 minutes post ingestion of study medication |
|
|
|
| Secondary | Proportion of Participants With Agreement of the Great Taste of the Product | Participants were asked to response to question "the product tastes great" using a 5 point agreement scale (range from 1=strongly disagree to 5=strongly agree). Selection of the top 2 choices (strongly agree and somewhat agree) from the scale was considered as agreement of the great taste. | All participants who received the study medication and had an evaluation data for study medication | Posted | Number | 95% Confidence Interval | Proportion of participants | Up to 5 minutes post ingestion of study medication |
|
|
|
| Secondary | Time to Perception of Cooling Sensation | The mean time point at which cooling was initially perceived was claimed as the onset of cooling. The mean onsets of cooling sensation in the mouth, nose and throat were reported. | All participants who received the study medication and had an evaluation data for study medication | Posted | Mean | 95% Confidence Interval | Seconds | Up to 60 minutes post ingestion of study medication |
|
|
|
| Secondary | Duration of Cooling Sensation | Participants who reported that they never experienced a cooling sensation were not included in the model. Those for whom the cooling sensation extended for 60 minutes or more were considered right-censored and were treated as such in the model. The median time of cooling sensation in the mouth, nose and throat was reported. Dispersion values were not calculated for this sensory study. | All participants who received the study medication and had an evaluation data for study medication | Posted | Median | Full Range | Minutes | Up to 60 minutes post ingestion of study medication |
|
|
|
| 0 |
| 442 |
| 0 |
| 442 |
| 9 |
| 442 |
| Vomiting | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 22.1 | Non-systematic Assessment |
|
| Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Salivary duct inflammation | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Dyspepsia | Gastrointestinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Rhinorrhea | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Non-systematic Assessment |
|
| Ocular sensory symptom | Eye disorders | MedDRA 22.1 | Non-systematic Assessment |
|
Not provided
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D007154 | Immune System Diseases |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| ...Refreshing in Throat |
|
|
| Cooling in Throat |
|
|
| Cooling in the Throat |
|