Trial · NCT01918033
A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)
NCT01918033, Phase 3, Completed, Organon and Co; results first posted 2014-08-15
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200). Trials, record NCT01918033. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01918033
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of the Efficacy and Safety of Desloratadine (MK-4117) in Japanese Participants With Perennial Allergic Rhinitis (MK-4117-200)
- NCT number
- NCT01918033
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 608 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Perennial Allergic Rhinitis
- Interventions
- Desloratadine 5 mg, Placebo
- First posted
- 2013-08-07
- Last updated
- 2024-06-18
- Results first posted
- 2014-08-15
Source ClinicalTrials.gov
Registered outcomes11
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) Assessed by the Investigator at Week 2 | Baseline and Week 2 | The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms. |
| Primary | Number of Participants Experiencing an Adverse Event (AE) | Up to Week 4 | An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who experienced an AE, regardless of causality or severity, was summarized. |
| Primary | Number of Participants Discontinuing Study Drug Due to an AE | Up to Week 2 | An AE is defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of the study drug or protocol-specified procedure, whether or not considered related to the study drug or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study drug, is also an AE. The number of participants who discontinued study drug, whether permanently or temporarily, due to an AE was summarized. |
| Secondary | Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1 | Baseline and Day 3, Week 1 | The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). The TNSS is the sum of the 4 nasal symptom sub-scores. TNSS scores could range from 0 to 12, with a higher score indicating more frequent/severe nasal symptoms. |
| Secondary | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Baseline and Day 3, Week 1, Week 2 | The investigator interviewed and examined participants to evaluate for nasal symptoms of: sneezing (daily frequency of attackes; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Nasal symptom sub-scores could range from 0 to 3, with a higher nasal symptom sub-score indicating more frequent/severe nasal symptoms. |
| Secondary | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Baseline and Day 3, Week 1, Week 2 | The investigator conducted rhinoscopic examinations on participants to evaluate: swelling of inferior nasal concha mucosa (INCM) (score of 0=none to 3=middle nasal concha is not visible), coloring of inferior nasal concha mucosa (INCM) (score of 0=normal to 3=pale), and nasal discharge production (NDP) (score of 0=none to 3=congesting). The score for each nasal finding component could range from 0 to 3, with a higher score indicating more severe symptoms. |
| Secondary | Change From Baseline in Eye Symptom Score Assessed by the Investigator | Baseline and Day 3, Week 1, Week 2 | The investigator interviewed and examined participants for eye (itching) symptoms (score of 0=none to 3=eye is itchy, requiring frequent rubbing of eye). Eye symptom scores could range from 0 to 3, with a higher score indicating greater eye itchiness. |
| Secondary | Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator | Day 3, Week 1, Week 2 | The investigator comprehensively evaluated participants on global improvement according to 5 grades: 1=remarkably improved, 2= moderately improved, 3=slightly improved, 4=unchanged, and 5=aggravated. The number of participants who were evaluated as remarkably improved and moderately improved was calculated. |
| Secondary | Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator | Baseline and Day 3, Week 1, Week 2 | The investigator interviewed participants at Baseline, Day 3, Week 1 and Week 2 to evaluate interference with daily activities according to the following scale: 0=none, 1=nasal symptom interferes with daily activities from time to time (+), 2=between 1 and 3 (++), and 3=nasal symtom interferes with daily activity often (+++). Interference with daily activities scores could range from 0 to 3, with a higher score indicating greater interference with daily activities. |
| Secondary | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Baseline and Day 3, Week 1, Week 2 | Participants evaluated themselves in their daily allergy diaries for nasal symptoms of: sneezing (daily frequency of attacks; score of 0=less than 1 time to 3=11+ times), rhinorrhea (daily frequency of blowing nose; score of 0=less than 1 time to 3=11+ times), nasal congestion (score of 0=less than nasal blockage without oral breathing to 3=severe nasal blockage causing prolonged oral breathing in a day), and nasal itching (score of 0=none to 3=nose is itchy, requiring frequent rubbing or blowing nose). Each nasal symptom sub-score could range from 0 to 3, with a higher sub-score indicating more frequent/severe nasal symptoms. |
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 | Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2 | Baseline and Week 2 | The Full Analysis Set (FAS) population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for TNSS. | Score on a Scale | LEAST_SQUARES_MEAN |
| PRIMARY | Number of Participants Experiencing an Adverse Event (AE) | Up to Week 4 | The All-Subjects-as-Treated (ASaT) population consisted of all participants who received at least one dose of study drug. | Participants | NUMBER |
| PRIMARY | Number of Participants Discontinuing Study Drug Due to an AE | Up to Week 2 | The ASaT population consisted of all participants who received at least one dose of study drug. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1 | Baseline and Day 3, Week 1 | The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for TNSS. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Nasal Symptom Sub-Scores Assessed by the Investigator | Baseline and Day 3, Week 1, Week 2 | The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for nasal symptom sub-scores as assessed by the investigator. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Nasal Finding Score Assessed by the Investigator | Baseline and Day 3, Week 1, Week 2 | The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for nasal finding score. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Eye Symptom Score Assessed by the Investigator | Baseline and Day 3, Week 1, Week 2 | The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for eye symptom score as assessed by the investigator. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Moderate-to-Remarkable Improvement in Global Improvement Assessed by the Investigator | Day 3, Week 1, Week 2 | The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for global improvement. | Participants | NUMBER |
| SECONDARY | Change From Baseline in Score on Interference With Daily Activities Assessed by the Investigator | Baseline and Day 3, Week 1, Week 2 | The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for interference with daily activities. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Nasal Symptom Sub-Scores Reported in Participant Diaries | Baseline and Day 3, Week 1, Week 2 | The FAS population consisted of all participants who took at least one dose of study drug and had a baseline or at least one post-baseline assessment for participant-rated nasal symptom score. | Score on a Scale | LEAST_SQUARES_MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group150
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) Assessed by the Investigator at Week 2 | Desloratadine 5 mg | -1.96 | 95% Confidence Interval 2.21 | Score on a Scale | |
| Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2 | Desloratadine 10 mg | -1.94 | 95% Confidence Interval 2.21 | Score on a Scale | |
| Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Week 2 | Placebo | -1.87 | 95% Confidence Interval 2.34 | Score on a Scale | |
| Number of Participants Experiencing an Adverse Event (AE) | Desloratadine 5 mg | 27 | Participants | ||
| Number of Participants Experiencing an Adverse Event (AE) | Desloratadine 10 mg | 29 | Participants | ||
| Number of Participants Experiencing an Adverse Event (AE) | Placebo | 20 | Participants | ||
| Number of Participants Discontinuing Study Drug Due to an AE | Desloratadine 5 mg | 1 | Participants | ||
| Number of Participants Discontinuing Study Drug Due to an AE | Desloratadine 10 mg | 0 | Participants | ||
| Number of Participants Discontinuing Study Drug Due to an AE | Placebo | 2 | Participants | ||
| Change From Baseline in Total Nasal Symptom Score (TNSS) Assessed by the Investigator at Day 3 and Week 1 | Desloratadine 5 mg | Change from Baseline (BL) at Day 3 | -1.12 | 95% Confidence Interval 2.05 | Score on a Scale |
1 to 10 of 150Source ClinicalTrials.gov
See all 150 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Desloratadine 5 mg | 203 | |
| Overall Study | STARTED | Desloratadine 10 mg | 203 | |
| Overall Study | STARTED | Placebo | 202 | |
| Overall Study | Treated | Desloratadine 5 mg | 202 | |
| Overall Study | Treated | Desloratadine 10 mg | 203 | |
| Overall Study | Treated | Placebo | 201 | |
| Overall Study | COMPLETED | Desloratadine 5 mg | 198 | |
| Overall Study | COMPLETED | Desloratadine 10 mg | 201 | |
| Overall Study | COMPLETED | Placebo | 199 | |
| Overall Study | NOT COMPLETED | Desloratadine 5 mg | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events6
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 | Nasphopharyngitis | Infections and infestations | Desloratadine 5 mg | 11 | 202 | 12 |
| other | Nasphopharyngitis | Infections and infestations | Desloratadine 10 mg | 17 | 203 | 17 |
| other | Nasphopharyngitis | Infections and infestations | Placebo | 9 | 201 | 10 |
| serious | Epilepsy | Nervous system disorders | Desloratadine 5 mg | 1 | 202 | 1 |
| serious | Epilepsy | Nervous system disorders | Desloratadine 10 mg | 0 | 203 | 0 |
| serious | Epilepsy | Nervous system disorders | Placebo | 0 | 201 | 0 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Desloratadine 5 mg | ||
| Total, all-cause mortality | Desloratadine 10 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Desloratadine 5 mg | 11 | 202 |
| Total, other adverse events | Desloratadine 10 mg | 17 | 203 |
| Total, other adverse events | Placebo | 9 | 201 |
| Total, serious adverse events | Desloratadine 5 mg | 1 | 202 |
| Total, serious adverse events | Desloratadine 10 mg | 0 | 203 |
| Total, serious adverse events | Placebo | 0 | 201 |
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/NCT01918033
GET https://conductscience.org/api/trials/v1/NCT01918033/results?page=2