Trial · NCT02320396
Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204)
NCT02320396, Phase 3, Completed, Organon and Co; results first posted 2016-05-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204). Trials, record NCT02320396. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02320396
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Seasonal Allergic Rhinitis (MK-4117-204)
- NCT number
- NCT02320396
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 449 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Seasonal Allergic Rhinitis
- Interventions
- Desloratadine 5 mg, Placebo
- First posted
- 2014-12-19
- Last updated
- 2024-05-17
- Results first posted
- 2016-05-30
Source ClinicalTrials.gov
Registered outcomes13
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 (TNSS) During 2 Weeks of Therapy | Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment | The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 \[\<1 time or "none"\] to 4 \[≥21 times\]), rhinorrhea (daily frequency of blowing nose scored from 0 \[\<1 time or "none"\] to 4 \[≥21 times\]), nasal congestion (scored from 0 \[no nasal blockage\] to 4 \[completely obstructed all day\]), and nasal itching (scored from 0 \[none\] to 4 \[nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant's diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement was an average from Day 1 to Day 13 (2 week average). Change from BL = Post BL measurement - BL measurement. |
| Primary | Number of Participants Who Experience at Least One Adverse Event (AE) | Up to 4 weeks (Up to 2 weeks after last dose of study drug) | An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. |
| Primary | Number of Participants Who Discontinue Study Drug Due to an AE | Up to 2 weeks | An AE was defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product or protocol-specified procedure, whether or not considered related to the medicinal product or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also an AE. |
| Secondary | Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment | Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average) of double-blind treatment | The TNSS was used to evaluate participant nasal symptoms of: sneezing (daily frequency of attacks scored from 0 \[\<1 time or "none"\] to 4 \[≥21 times\]), rhinorrhea (daily frequency of blowing nose scored from 0 \[\<1 time or "none"\] to 4 \[≥21 times\]), nasal congestion (scored from 0 \[no nasal blockage\] to 4 \[completely obstructed all day\]), and nasal itching (scored from 0 \[none\] to 4 \[nose is itchy, requiring frequent rubbing or blowing nose) as rated in the participant's diary. The TNSS was the sum of the 4 nasal symptom sub-scores. TNSS scores ranged from 0 to 16, with a higher score indicating more frequent/severe nasal symptoms. Baseline (BL) measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 1 was an average from Day 1 to Day 7 and post-BL measurement for Week 2 was an average from Day 8 to Day 13. Change from BL = Post BL measurement - BL measurement. |
| Secondary | Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) | Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment | Nasal symptoms sub-scores rated in the participant's diary included sneezing (daily frequency of attacks scored from 0 \[\<1 time or "none"\] to 4 \[≥21 times\]), rhinorrhea (daily frequency of blowing nose scored from 0 \[\<1 time or "none"\] to 4 \[≥21 times\]), nasal congestion (scored from 0 \[no nasal blockage\] to 4 \[completely obstructed all day\]), and nasal itching (scored from 0 \[none\] to 4 \[nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 1 was an average of scores from Day 1 to Day 7. Change from BL = Post BL measurement - BL measurement. |
| Secondary | Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) | Baseline, Day 8 to 13 (Week 2 average) of double-blind treatment | Nasal symptoms sub-scores rated in the participant's diary included sneezing (daily frequency of attacks scored from 0 \[\<1 time or "none"\] to 4 \[≥21 times\]), rhinorrhea (daily frequency of blowing nose scored from 0 \[\<1 time or "none"\] to 4 \[≥21 times\]), nasal congestion (scored from 0 \[no nasal blockage\] to 4 \[completely obstructed all day\]), and nasal itching (scored from 0 \[none\] to 4 \[nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Change from BL = Post BL measurement - BL measurement. |
| Secondary | Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy | Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) | Nasal symptoms sub-scores rated in the participant's diary included sneezing (daily frequency of attacks scored from 0 \[\<1 time or "none"\] to 4 \[≥21 times\]), rhinorrhea (daily frequency of blowing nose scored from 0 \[\<1 time or "none"\] to 4 \[≥21 times\]), nasal congestion (scored from 0 \[no nasal blockage\] to 4 \[completely obstructed all day\]), and nasal itching (scored from 0 \[none\] to 4 \[nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores ranged from 0 to 4, with a higher score indicating more frequent/severe nasal symptoms. BL measurement was an average of scores for 3 days prior to treatment (during Confirmation of Symptom Period). Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement - BL measurement. |
| Secondary | Change From Baseline to Week 1 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) | Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment | Eye symptoms rated in the participant's diary included eye pruritis (eye itching scored from 0 \[none\] to 4 \[severe eye itching, requiring frequent rubbing of eye\]) and watering eyes (scored from 0 \[none\] to 4 \[severe eye watering requiring frequent wiping of eyes\]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. Baseline measurement was an average of scores for 3 days prior to treatment. Post-baseline measurement for Week 1 was an average of scores from Day 1 to Day 7. Change from BL = Post BL measurement - BL measurement. |
| Secondary | Change From Baseline to Week 2 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) | Baseline, Day 8 to 13 (Week 2) of double-blind treatment | Eye symptoms rated in the participant's diary included eye pruritis (eye itching scored from 0 \[none\] to 4 \[severe eye itching, requiring frequent rubbing of eye\]) and watering eyes (scored from 0 \[none\] to 4 \[severe eye watering requiring frequent wiping of eyes\]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. Baseline measurement was an average of scores for 3 days prior to treatment. Post-BL measurement for Week 2 was an average of scores from Day 8 to Day 13. Change from BL = Post BL measurement - BL measurement. |
| Secondary | Change From Baseline in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) During 2 Weeks of Therapy | Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) | Eye symptoms rated in the participant's diary included eye pruritis (eye itching scored from 0 \[none\] to 4 \[severe eye itching, requiring frequent rubbing of eye\]) and watering eyes (scored from 0 \[none\] to 4 \[severe eye watering requiring frequent wiping of eyes\]). Eye symptom scores ranged from 0 to 4, with a higher score indicating greater severity of symptom. The change from baseline in eye pruritis, eye watering, and the worse one of either eye symptom were reported. BL measurement was an average of scores for 3 days prior to treatment. Post-BL measurement for 2 week Average was an average of scores from Day 1 to Day 13. Change from BL = Post BL measurement - BL measurement. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
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 (TNSS) During 2 Weeks of Therapy | Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) of double-blind treatment | The Full Analysis Set (FAS); all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation (average score of 2 weeks). | units on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Number of Participants Who Experience at Least One Adverse Event (AE) | Up to 4 weeks (Up to 2 weeks after last dose of study drug) | All Participants as Treated (APaT); all participants who received ≥1 dose of study treatment. | participants | NUMBER |
| PRIMARY | Number of Participants Who Discontinue Study Drug Due to an AE | Up to 2 weeks | APaT; all participants who received ≥1 dose of study treatment. | participants | NUMBER |
| SECONDARY | Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment | Baseline, Day 1 to 7 (Week 1 average), Day 8 to 13 (Week 2 average) of double-blind treatment | The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 1 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) | Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment | The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 2 in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) | Baseline, Day 8 to 13 (Week 2 average) of double-blind treatment | The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Each Nasal Symptom Sub-Score (Sneezing, Rhinorrhea, Nasal Congestion and Nasal Itching) During 2 Weeks of Therapy | Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) | The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 1 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) | Baseline, Day 1 to 7 (Week 1 average) of double-blind treatment | The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline to Week 2 in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) | Baseline, Day 8 to 13 (Week 2) of double-blind treatment | The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation. | units on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Eye Symptoms (Pruritus, Watering Eyes and the Worse One of Either Pruritus or Watering Eyes) During 2 Weeks of Therapy | Baseline, Day 1 to Day 13 (Weeks 1 through 2 average) | The FAS; all randomized participants who took ≥1 dose of study treatment, and have a BL (average of score for 3 days prior to treatment) observation or one post BL observation. | units on a scale | LEAST_SQUARES_MEAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group74
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 (TNSS) During 2 Weeks of Therapy | Desloratadine | -1.41 | 95% Confidence Interval -1.64 to -1.19 | units on a scale | |
| Change From Baseline in Total Nasal Symptom Score (TNSS) During 2 Weeks of Therapy | Placebo | -0.59 | 95% Confidence Interval -0.81 to -0.36 | units on a scale | |
| Number of Participants Who Experience at Least One Adverse Event (AE) | Desloratadine | 19 | participants | ||
| Number of Participants Who Experience at Least One Adverse Event (AE) | Placebo | 13 | participants | ||
| Number of Participants Who Discontinue Study Drug Due to an AE | Desloratadine | 2 | participants | ||
| Number of Participants Who Discontinue Study Drug Due to an AE | Placebo | 2 | participants | ||
| Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment | Desloratadine | Week 1 | -1.19 | 95% Confidence Interval -1.42 to -0.96 | units on a scale |
| Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment | Placebo | Week 1 | -0.38 | 95% Confidence Interval -0.61 to -0.15 | units on a scale |
| Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment | Desloratadine | Week 2 | -1.69 | 95% Confidence Interval -1.96 to -1.41 | units on a scale |
| Change From Baseline in TNSS for Week 1 and Week 2 of Double-blind Treatment | Placebo | Week 2 | -0.84 | 95% Confidence Interval -1.12 to -0.57 | units on a scale |
1 to 10 of 74Source ClinicalTrials.gov
See all 74 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Desloratadine | 224 | |
| Overall Study | STARTED | Placebo | 225 | |
| Overall Study | Treated (Full Analysis Set) | Desloratadine | 223 | |
| Overall Study | Treated (Full Analysis Set) | Placebo | 225 | |
| Overall Study | COMPLETED | Desloratadine | 220 | |
| Overall Study | COMPLETED | Placebo | 221 | |
| Overall Study | NOT COMPLETED | Desloratadine | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 4 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Postoperative wound infection | Infections and infestations | Desloratadine | 1 | 223 | 1 |
| serious | Postoperative wound infection | Infections and infestations | Placebo | 0 | 225 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Desloratadine | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Desloratadine | 0 | 223 |
| Total, other adverse events | Placebo | 0 | 225 |
| Total, serious adverse events | Desloratadine | 1 | 223 |
| Total, serious adverse events | Placebo | 0 | 225 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Desloratadine vs Placebo: Number of Participants Who Discontinue Study Drug Due to an AE | Trial comparisons |
| Desloratadine vs Placebo: Number of Participants Who Experience at Least One Adverse Event (AE) | Trial comparisons |
| Desloratadine vs Placebo: serious adverse events | Trial comparisons |
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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