Trial · NCT03855228
Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)
NCT03855228, Phase 3, Completed, Organon and Co; results first posted 2019-07-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145). Trials, record NCT03855228. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03855228
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Mometasone Furoate Nasal Spray With the Addition of Loratadine Versus Placebo in Participants With Seasonal Allergic Rhinitis (C94-145)
- NCT number
- NCT03855228
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 704 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Rhinitis, Allergic
- Interventions
- Mometasone furoate nasal spray (MFNS), Loratadine, Placebo nasal spray, Placebo tablet
- First posted
- 2019-02-26
- Last updated
- 2022-02-09
- Results first posted
- 2019-07-26
- Limitations and caveats
- AE Preferred Terms were converted from WHO-ART dictionary to the MedDRA version 12.0.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Total Nasal Symptom Score (Assessed by Participant) | Baseline and days 1 through 15 (average of 15 days of treatment) | Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total nasal symptom scores assessed by participants. Participants scored 4 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total nasal symptom score (range: 0-12); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment. |
| Primary | Change From Baseline in Total Symptom Score (Assessed by Participant) | Baseline and days 1 through 15 (average of 15 days of treatment) | Mean change from baseline (CFB), averaged over study days 1-15, is calculated for total symptom scores assessed by participants. Participants scored 8 symptoms (rhinorrhea; nasal stuffiness; nasal itching; sneezing; itching/burning eyes; tearing/watering eyes; eye redness; and ear/palate itching) in diaries on a scale from 0 (none) to 3 (severe). Scores sum to a total symptom score (range: 0-24); higher values indicate greater severity. A decrease in symptom severity is reflected by a negative CFB. CFB is the 15-day average score minus baseline score. Scores were recorded twice daily, in morning (AM) and night (PM). Average AM/PM scores are first calculated separately, then averaged together to compute the 15-day average score. If diary entries were missing, an average AM or PM score was not calculated. If neither average AM nor PM score was calculated, total 15-day average score was not calculated. Baseline score is an average of the three AM and three PM scores preceding treatment. |
| Secondary | Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician) | Baseline and study day 15 | The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity. |
| Secondary | Change From Baseline in Total Symptom Score on Day 15 (Assessed by Physician) | Baseline and study day 15 | The mean change from baseline on study day 15 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity. |
| Secondary | Change From Baseline in Total Nasal Symptom Score on Day 8 (Assessed by Physician) | Baseline and study day 8 | The mean change from baseline on study day 15 was calculated for total nasal symptom scores assessed by physician. Total nasal symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, and sneezing scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-12 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity. |
| Secondary | Change From Baseline in Total Symptom Score on Day 8 (Assessed by Physician) | Baseline and study day 8 | The mean change from baseline on study day 8 was calculated for total symptom scores assessed by physician. Total symptom scores are a composite of the following: rhinorrhea, nasal stuffiness (congestion), nasal itching, sneezing, itching/burning eyes, tearing/watering eyes, redness of the eyes, and itching of the ears or palate scores. Physician scored each symptom during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe), totaling to a composite score from 0-24 where a higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity. |
| Secondary | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 15 (Assessed by Physician) | Baseline and study day 15 | The mean change from baseline on study day 15 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 15, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity. |
| Secondary | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 8 (Assessed by Physician) | Baseline and study day 8 | The mean change from baseline on study day 8 was calculated for overall condition of rhinitis. Physicians scored participant rhinitis condition during study visit at baseline and study day 8, on a scale from 0 (none) to 3 (severe). A higher value indicates greater severity. A negative change from baseline indicates a decrease in symptom severity. |
| Secondary | Response to Therapy on Day 15 (Assessed by Physician) | Study day 15 | Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 15. A higher value indicates weaker response. |
| Secondary | Response to Therapy on Day 8 (Assessed by Physician) | Study day 8 | Mean response to therapy based on the participant's status relative to baseline. Physician scored participant's response on a scale from 1 (complete relief) to 5 (treatment failure) during study visit on study day 8. A higher value indicates weaker response. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Total Nasal Symptom Score (Assessed by Participant) | Baseline and days 1 through 15 (average of 15 days of treatment) | Includes randomized participants with ≥1 valid post-Baseline visit, no major protocol violations, and evaluable data for the days 1-15 average. | Score on a scale | MEAN |
| PRIMARY | Change From Baseline in Total Symptom Score (Assessed by Participant) | Baseline and days 1 through 15 (average of 15 days of treatment) | Includes randomized participants with ≥1 valid post-Baseline visit, no major protocol violations, and evaluable data for the days 1-15 average. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Total Nasal Symptom Score on Day 15 (Assessed by Physician) | Baseline and study day 15 | All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Total Symptom Score on Day 15 (Assessed by Physician) | Baseline and study day 15 | All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Total Nasal Symptom Score on Day 8 (Assessed by Physician) | Baseline and study day 8 | All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Total Symptom Score on Day 8 (Assessed by Physician) | Baseline and study day 8 | All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 15 (Assessed by Physician) | Baseline and study day 15 | All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in Overall Condition of Seasonal Allergic Rhinitis (SAR) on Day 8 (Assessed by Physician) | Baseline and study day 8 | All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment. | Score on a scale | MEAN |
| SECONDARY | Response to Therapy on Day 15 (Assessed by Physician) | Study day 15 | All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment. | Score on a scale | MEAN |
| SECONDARY | Response to Therapy on Day 8 (Assessed by Physician) | Study day 8 | All randomized participants with: ≥1 valid post-Baseline visit; no major protocol violations; and who had an observation for the respective endpoint prior to either significant dose noncompliance, or onset of an adverse event that may have interfered with allergic rhinitis assessment. | Score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group72
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Total Nasal Symptom Score (Assessed by Participant) | MFNS 200 μg + Loratadine 10 mg | Baseline | 7.9 | Standard Deviation 2.2 | Score on a scale |
| Change From Baseline in Total Nasal Symptom Score (Assessed by Participant) | MFNS 200 μg | Baseline | 7.8 | Standard Deviation 2.2 | Score on a scale |
| Change From Baseline in Total Nasal Symptom Score (Assessed by Participant) | Loratadine 10 mg | Baseline | 7.9 | Standard Deviation 2.2 | Score on a scale |
| Change From Baseline in Total Nasal Symptom Score (Assessed by Participant) | Placebo | Baseline | 8.0 | Standard Deviation 2.1 | Score on a scale |
| Change From Baseline in Total Nasal Symptom Score (Assessed by Participant) | MFNS 200 μg + Loratadine 10 mg | Change From Baseline Days 1-15 | -3.0 | Standard Deviation 2.6 | Score on a scale |
| Change From Baseline in Total Nasal Symptom Score (Assessed by Participant) | MFNS 200 μg | Change From Baseline Days 1-15 | -2.7 | Standard Deviation 2.5 | Score on a scale |
| Change From Baseline in Total Nasal Symptom Score (Assessed by Participant) | Loratadine 10 mg | Change From Baseline Days 1-15 | -1.9 | Standard Deviation 2.2 | Score on a scale |
| Change From Baseline in Total Nasal Symptom Score (Assessed by Participant) | Placebo | Change From Baseline Days 1-15 | -1.4 | Standard Deviation 2.2 | Score on a scale |
| Change From Baseline in Total Symptom Score (Assessed by Participant) | MFNS 200 μg + Loratadine 10 mg | Baseline | 14.3 | Standard Deviation 4.1 | Score on a scale |
| Change From Baseline in Total Symptom Score (Assessed by Participant) | MFNS 200 μg | Baseline | 14.2 | Standard Deviation 4.4 | Score on a scale |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 results by groupParticipant flow16
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | MFNS 200 μg + Loratadine 10 mg | 169 | |
| Overall Study | STARTED | MFNS 200 μg | 176 | |
| Overall Study | STARTED | Loratadine 10 mg | 182 | |
| Overall Study | STARTED | Placebo | 177 | |
| Overall Study | Treated | MFNS 200 μg + Loratadine 10 mg | 169 | |
| Overall Study | Treated | MFNS 200 μg | 176 | |
| Overall Study | Treated | Loratadine 10 mg | 181 | |
| Overall Study | Treated | Placebo | 176 | |
| Overall Study | COMPLETED | MFNS 200 μg + Loratadine 10 mg | 166 | |
| Overall Study | COMPLETED | MFNS 200 μg | 167 |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 participant flowAdverse events4
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 | HEADACHE | Nervous system disorders | MFNS Pus Loratadine | 22 | 169 | 35 |
| other | HEADACHE | Nervous system disorders | MFNS 200 | 22 | 176 | 28 |
| other | HEADACHE | Nervous system disorders | Loratadine | 33 | 181 | 41 |
| other | HEADACHE | Nervous system disorders | Placebo | 21 | 176 | 31 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MFNS Pus Loratadine | 0 | 169 |
| Total, all-cause mortality | MFNS 200 | 0 | 176 |
| Total, all-cause mortality | Loratadine | 0 | 181 |
| Total, all-cause mortality | Placebo | 0 | 176 |
| Total, other adverse events | MFNS Pus Loratadine | 22 | 169 |
| Total, other adverse events | MFNS 200 | 22 | 176 |
| Total, other adverse events | Loratadine | 33 | 181 |
| Total, other adverse events | Placebo | 21 | 176 |
| Total, serious adverse events | MFNS Pus Loratadine | 0 | 169 |
| Total, serious adverse events | MFNS 200 | 0 | 176 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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/NCT03855228
GET https://conductscience.org/api/trials/v1/NCT03855228/results?page=2