Trial · NCT04162795
A Study to Evaluate Cooling Sensation of an Allergy Product in Adults With a History of Allergies
NCT04162795, Phase 4, Completed, Bayer; results first posted 2021-02-04
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate Cooling Sensation of an Allergy Product in Adults With a History of Allergies. Trials, record NCT04162795. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04162795
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Cooling Sensation of an Allergy Product in Adults With a History of Allergies
- NCT number
- NCT04162795
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 468 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Allergic Rhinitis
- Interventions
- Loratadine (Claritin, BAY76-2211)
- First posted
- 2019-11-14
- Last updated
- 2021-02-04
- Results first posted
- 2021-02-04
- Limitations and caveats
- Kaplan-Meier Estimates of the duration of the cooling sensation were not able to be reported in this data set.
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants With Agreement of Perception of Cooling Sensation | Up to 5 minutes post ingestion of study medication | 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. |
| Secondary | Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location | Up to 5 minutes post ingestion of study medication | 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. |
| Secondary | Proportion of Participants With Agreement of Perception of Refreshing Sensation | Up to 5 minutes post ingestion of study medication | 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. |
| Secondary | Proportion of Participants With Agreement of the Refreshing of the Cooling Sensation | Up to 5 minutes post ingestion of study medication | 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. |
| Secondary | Proportion of Participants With Agreement of the Unique Sensory Experience for an Allergy Medicine | Up to 5 minutes post ingestion of study medication | 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. |
| Secondary | Proportion of Participants With Agreement of Soothing Feeling on the Throat | Up to 5 minutes post ingestion of study medication | 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. |
| Secondary | Proportion of Participants With Agreement of Liking the Flavor Sensation of the Product | Up to 5 minutes post ingestion of study medication | 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. |
| Secondary | Proportion of Participants With Agreement of the Enjoyable Product Experience | Up to 5 minutes post ingestion of study medication | 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. |
| Secondary | Proportion of Participants With Agreement of the Great Taste of the Product | Up to 5 minutes post ingestion of study medication | 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. |
| Secondary | Time to Perception of Cooling Sensation | Up to 60 minutes post ingestion of study medication | 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. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Proportion of Participants With Agreement of Perception of Cooling Sensation | Up to 5 minutes post ingestion of study medication | All participants who received the study medication and had an evaluation data for study medication | Proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location | Up to 5 minutes post ingestion of study medication | All participants who received the study medication and had an evaluation data for study medication | Proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants With Agreement of Perception of Refreshing Sensation | Up to 5 minutes post ingestion of study medication | All participants who received the study medication and had an evaluation data for study medication | Proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants With Agreement of the Refreshing of the Cooling Sensation | Up to 5 minutes post ingestion of study medication | All participants who received the study medication and had an evaluation data for study medication | Proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants With Agreement of the Unique Sensory Experience for an Allergy Medicine | Up to 5 minutes post ingestion of study medication | All participants who received the study medication and had an evaluation data for study medication | Proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants With Agreement of Soothing Feeling on the Throat | Up to 5 minutes post ingestion of study medication | All participants who received the study medication and had an evaluation data for study medication | Proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants With Agreement of Liking the Flavor Sensation of the Product | Up to 5 minutes post ingestion of study medication | All participants who received the study medication and had an evaluation data for study medication | Proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants With Agreement of the Enjoyable Product Experience | Up to 5 minutes post ingestion of study medication | All participants who received the study medication and had an evaluation data for study medication | Proportion of participants | NUMBER |
| SECONDARY | Proportion of Participants With Agreement of the Great Taste of the Product | Up to 5 minutes post ingestion of study medication | All participants who received the study medication and had an evaluation data for study medication | Proportion of participants | NUMBER |
| SECONDARY | Time to Perception of Cooling Sensation | Up to 60 minutes post ingestion of study medication | All participants who received the study medication and had an evaluation data for study medication | Seconds | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants With Agreement of Perception of Cooling Sensation | Loratadine Chewable Tablet | 0.99 | 95% Confidence Interval 0.98 to 1.00 | Proportion of participants | |
| Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location | Loratadine Chewable Tablet | Cooling in Mouth | 0.99 | 95% Confidence Interval 0.98 to 1.00 | Proportion of participants |
| Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location | Loratadine Chewable Tablet | Cooling in Nose | 0.71 | 95% Confidence Interval 0.67 to 0.76 | Proportion of participants |
| Proportion of Participants With Agreement of Perception of Cooling Sensation Per Location | Loratadine Chewable Tablet | Cooling in Throat | 0.93 | 95% Confidence Interval 0.90 to 0.95 | Proportion of participants |
| Proportion of Participants With Agreement of Perception of Refreshing Sensation | Loratadine Chewable Tablet | Refreshing | 0.96 | 95% Confidence Interval 0.94 to 0.98 | Proportion of participants |
| Proportion of Participants With Agreement of Perception of Refreshing Sensation | Loratadine Chewable Tablet | ...Refreshing in Mouth | 0.96 | 95% Confidence Interval 0.94 to 0.97 | Proportion of participants |
| Proportion of Participants With Agreement of Perception of Refreshing Sensation | Loratadine Chewable Tablet | ...Refreshing in Nose | 0.61 | 95% Confidence Interval 0.57 to 0.66 | Proportion of participants |
| Proportion of Participants With Agreement of Perception of Refreshing Sensation | Loratadine Chewable Tablet | ...Refreshing in Throat | 0.88 | 95% Confidence Interval 0.85 to 0.91 | Proportion of participants |
| Proportion of Participants With Agreement of the Refreshing of the Cooling Sensation | Loratadine Chewable Tablet | 0.96 | 95% Confidence Interval 0.94 to 0.97 | Proportion of participants | |
| Proportion of Participants With Agreement of the Unique Sensory Experience for an Allergy Medicine | Loratadine Chewable Tablet | 0.94 | 95% Confidence Interval 0.92 to 0.96 | Proportion of participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Loratadine Chewable Tablet | 468 | |
| Overall Study | COMPLETED | Loratadine Chewable Tablet | 442 | |
| Overall Study | NOT COMPLETED | Loratadine Chewable Tablet | 26 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Epistaxis | Respiratory, thoracic and mediastinal disorders | Loratadine Chewable Tablet | 1 | 442 | |
| other | Vomiting | Gastrointestinal disorders | Loratadine Chewable Tablet | 1 | 442 | |
| other | Rhinitis | Infections and infestations | Loratadine Chewable Tablet | 1 | 442 | |
| other | Laryngeal inflammation | Respiratory, thoracic and mediastinal disorders | Loratadine Chewable Tablet | 2 | 442 | |
| other | Salivary duct inflammation | Gastrointestinal disorders | Loratadine Chewable Tablet | 1 | 442 | |
| other | Dyspepsia | Gastrointestinal disorders | Loratadine Chewable Tablet | 2 | 442 | |
| other | Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Loratadine Chewable Tablet | 1 | 442 | |
| other | Ocular sensory symptom | Eye disorders | Loratadine Chewable Tablet | 1 | 442 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Loratadine Chewable Tablet | 0 | 442 |
| Total, other adverse events | Loratadine Chewable Tablet | 9 | 442 |
| Total, serious adverse events | Loratadine Chewable Tablet | 0 | 442 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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