Trial · NCT01469234
A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)
NCT01469234, Phase 4, Completed, Bayer; results first posted 2013-03-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712). Trials, record NCT01469234. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01469234
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)
- NCT number
- NCT01469234
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 255 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Rhinitis
- Interventions
- loratadine, fexofenadine, placebo to loratadine, placebo to fexofenadine
- First posted
- 2011-11-10
- Last updated
- 2015-03-11
- Results first posted
- 2013-03-22
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) | From time of sensitization (time 0) to end of visit (~8 hours) | The MSC Score is calculated as the sum of 5 individual symptom scores for Runny Nose, Itchy Nose, Sneezing, Watery Eyes, and Itchy Eyes. Each individual symptom is rated on a 5-point scale of severity: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The total MSC score ranges from 0 - 25. Increasing scores are associated with increasing severity. |
| Secondary | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | The individual symptom score for Runny Nose was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Runny Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. |
| Secondary | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | The individual symptom score for Itchy Nose was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. |
| Secondary | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | The individual symptom score for Sneezing was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Sneezing symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. |
| Secondary | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | The individual symptom score for Water Eyes was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Watery Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. |
| Secondary | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | The individual symptom score for Itchy Eyes was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. |
| Secondary | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | The individual symptom score for Nasal Congestion was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Nasal Congestion symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. |
| Secondary | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | The individual symptom score for Itchy Mouth/Throat/Ears was rated on a 5-point scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Mouth/Throat/Ears symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) | From time of sensitization (time 0) to end of visit (~8 hours) | Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point. | units on a scale | MEAN |
| SECONDARY | Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point. | units on a scale | MEAN |
| SECONDARY | Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point. | units on a scale | MEAN |
| SECONDARY | Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point. | units on a scale | MEAN |
| SECONDARY | Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point. | units on a scale | MEAN |
| SECONDARY | Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point. | units on a scale | MEAN |
| SECONDARY | Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point. | units on a scale | MEAN |
| SECONDARY | Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point | From time of sensitization (time 0) to end of visit (~8 hours) | Participants in the Intent-to-Treat (ITT) Population (defined as all participants who successfully exhibited appropriate sensitivity and were randomized to study treatment) who had data available.~N=Number of Participants Analyzed, n=number of participants with data available at the given time point. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group552
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) | Loratadine | 180 minutes (n=85, n=85, n=85) | 7.4 | Standard Deviation 4.51 | units on a scale |
| Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) | Fexofenadine | 180 minutes (n=85, n=85, n=85) | 6.7 | Standard Deviation 4.86 | units on a scale |
| Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) | Placebo | 180 minutes (n=85, n=85, n=85) | 8.5 | Standard Deviation 5.07 | units on a scale |
| Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) | Loratadine | 195 minutes (n=85, n=85, n=85) | 7.5 | Standard Deviation 4.84 | units on a scale |
| Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) | Fexofenadine | 195 minutes (n=85, n=85, n=85) | 6.7 | Standard Deviation 4.87 | units on a scale |
| Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) | Placebo | 195 minutes (n=85, n=85, n=85) | 8.9 | Standard Deviation 5.31 | units on a scale |
| Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) | Loratadine | 210 minutes (n=85, n=85, n=85) | 7.3 | Standard Deviation 4.73 | units on a scale |
| Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) | Fexofenadine | 210 minutes (n=85, n=85, n=85) | 6.5 | Standard Deviation 4.87 | units on a scale |
| Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) | Placebo | 210 minutes (n=85, n=85, n=85) | 8.7 | Standard Deviation 5.28 | units on a scale |
| Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) | Loratadine | 225 minutes (n=85, n=85, n=85) | 7.4 | Standard Deviation 4.63 | units on a scale |
1 to 10 of 552Source ClinicalTrials.gov
See all 552 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Loratadine | 85 | |
| Overall Study | STARTED | Fexofenadine | 85 | |
| Overall Study | STARTED | Placebo | 85 | |
| Overall Study | COMPLETED | Loratadine | 85 | |
| Overall Study | COMPLETED | Fexofenadine | 85 | |
| Overall Study | COMPLETED | Placebo | 85 | |
| Overall Study | NOT COMPLETED | Loratadine | 0 | |
| Overall Study | NOT COMPLETED | Fexofenadine | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Loratadine | ||
| Total, all-cause mortality | Fexofenadine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Loratadine | 0 | 85 |
| Total, other adverse events | Fexofenadine | 0 | 85 |
| Total, other adverse events | Placebo | 0 | 85 |
| Total, serious adverse events | Loratadine | 0 | 85 |
| Total, serious adverse events | Fexofenadine | 0 | 85 |
| Total, serious adverse events | Placebo | 0 | 85 |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01469234
GET https://conductscience.org/api/trials/v1/NCT01469234/results?page=2