Trial · NCT01916980
Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Eczema/Dermatitis and Dermal Pruritus (MK-4117-202)
NCT01916980, Phase 3, Completed, Organon and Co; results first posted 2014-11-19
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 Eczema/Dermatitis and Dermal Pruritus (MK-4117-202). Trials, record NCT01916980. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01916980
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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 Eczema/Dermatitis and Dermal Pruritus (MK-4117-202)
- NCT number
- NCT01916980
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 94 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Eczema, Dermatitis, Dermal Pruritus
- Interventions
- Desloratadine 5 mg
- First posted
- 2013-08-06
- Last updated
- 2024-06-18
- Results first posted
- 2014-11-19
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2 | Baseline Visit and Week 2 Visit | The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher sum score indicating greater severity. The change from Baseline in the sum of the daytime and nighttime pruritus/itch scores at Week 2 clinic visit was calculated. |
| Primary | Percentage of Participants Who Experienced at Least One Adverse Event (AE) | Up to 14 weeks (Up to 2 weeks after last dose dose of study drug) | An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a 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. |
| Primary | Percentage of Participants Who Discontinued Study Drug Due to an AE | Up to 12 weeks | An AE is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a 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. |
| Secondary | Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12 | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit | The Investigator assessed the severity of participant pruritus/itch during the daytime (0=Virtually no itching to 4=Cannot relax because of constant itching) and nighttime (0=Virtually no itching to 4=Cannot sleep because of itching). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime pruritus/itch scores at the Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated. |
| Secondary | Percentage of Participants With Moderate or Remarkable Improvement in the Global Improvement Rate of Pruritus/Itch Assessed by the Investigator at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit | The global improvement judgment criteria were used to assess overall improvement in pruritus/itch. The Investigator assessed the degree of severity of pruritus/itch based on 5 grades (1=Remarkably improved to 5=Aggravated) at Baseline and subsequent clinic visits. The percentages of participants who were remarkably improved (Grade 1=Pruritus/itch disappeared) or moderately improved (Grade 2=Pruritus/itch was greatly improved) at the Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated. |
| Secondary | Change From Baseline in the Pruritus/Itch Visual Analog Scale (VAS) Score Recorded by Participants at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit | Participants assessed the degree of their pruritus using a 100-mm visual analog scale (VAS; 0mm=No itch, 100mm=Worst imaginable itch) at Baseline and subsequent clinic visits. Pruritus/itch VAS scores could range from 0 to 100, with a higher score indicating more severe pruritus/itching. The changes from Baseline in the VAS scores for pruritus/itch at the Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 clinic visits were calculated. |
Source ClinicalTrials.gov
Outcomes6
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 Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2 | Baseline Visit and Week 2 Visit | The Full Analysis Set (FAS) population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed pruritus/itch score. | Score on a Scale | LEAST_SQUARES_MEAN |
| PRIMARY | Percentage of Participants Who Experienced at Least One Adverse Event (AE) | Up to 14 weeks (Up to 2 weeks after last dose dose of study drug) | The All-Participants-as-Treated (APaT) population consisted of all participants who received at least one dose of study drug. | Percentage of Participants | NUMBER |
| PRIMARY | Percentage of Participants Who Discontinued Study Drug Due to an AE | Up to 12 weeks | The APaT population consisted of all participants who received at least one dose of study drug. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12 | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit | The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed pruritus/itch score. | Score on a Scale | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With Moderate or Remarkable Improvement in the Global Improvement Rate of Pruritus/Itch Assessed by the Investigator at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit | The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for Investigator-assessed Global Improvement. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in the Pruritus/Itch Visual Analog Scale (VAS) Score Recorded by Participants at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 | Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit | The FAS population consisted of all participants who received at least one dose of study drug and had a Baseline or at least one post-Baseline observation for participant-assessed pruritus/itch VAS score. | Score on a Scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group46
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 Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2 | Desloratadine: Eczema/Dermatitis | -1.63 | 95% Confidence Interval -2.01 to -1.25 | Score on a Scale | |
| Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2 | Desloratadine: Dermal Pruritus | -2.17 | 95% Confidence Interval -2.74 to -1.61 | Score on a Scale | |
| Percentage of Participants Who Experienced at Least One Adverse Event (AE) | Desloratadine: Eczema/Dermatitis | 53.8 | Percentage of Participants | ||
| Percentage of Participants Who Experienced at Least One Adverse Event (AE) | Desloratadine: Dermal Pruritus | 48.3 | Percentage of Participants | ||
| Percentage of Participants Who Discontinued Study Drug Due to an AE | Desloratadine: Eczema/Dermatitis | 6.2 | Percentage of Participants | ||
| Percentage of Participants Who Discontinued Study Drug Due to an AE | Desloratadine: Dermal Pruritus | 6.9 | Percentage of Participants | ||
| Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12 | Desloratadine: Eczema/Dermatitis | Change from Baseline at Day 3 (n=65, 29) | -0.83 | 95% Confidence Interval -1.18 to -0.49 | Score on a Scale |
| Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12 | Desloratadine: Dermal Pruritus | Change from Baseline at Day 3 (n=65, 29) | -1.59 | 95% Confidence Interval -2.10 to -1.07 | Score on a Scale |
| Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12 | Desloratadine: Eczema/Dermatitis | Change from Baseline at Week 1 (n=65, 29) | -1.29 | 95% Confidence Interval -1.66 to -0.92 | Score on a Scale |
| Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Day 3, Week 1, Week 4, Week 6, Week 8 and Week 12 | Desloratadine: Dermal Pruritus | Change from Baseline at Week 1 (n=65, 29) | -2.07 | 95% Confidence Interval -2.62 to -1.52 | Score on a Scale |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Desloratadine: Eczema/Dermatitis | 65 | |
| Overall Study | STARTED | Desloratadine: Dermal Pruritus | 29 | |
| Overall Study | COMPLETED | Desloratadine: Eczema/Dermatitis | 58 | |
| Overall Study | COMPLETED | Desloratadine: Dermal Pruritus | 25 | |
| Overall Study | NOT COMPLETED | Desloratadine: Eczema/Dermatitis | 7 | |
| Overall Study | NOT COMPLETED | Desloratadine: Dermal Pruritus | 4 |
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 | Nasopharyngitis | Infections and infestations | Desloratadine: Eczema/Dermatitis | 13 | 65 | 16 |
| other | Nasopharyngitis | Infections and infestations | Desloratadine: Dermal Pruritus | 4 | 29 | 4 |
| other | Somnolence | Nervous system disorders | Desloratadine: Eczema/Dermatitis | 4 | 65 | 4 |
| other | Somnolence | Nervous system disorders | Desloratadine: Dermal Pruritus | 0 | 29 | 0 |
| other | Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | Desloratadine: Eczema/Dermatitis | 0 | 65 | 0 |
| other | Seborrhoeic dermatitis | Skin and subcutaneous tissue disorders | Desloratadine: Dermal Pruritus | 2 | 29 | 2 |
| serious | Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Desloratadine: Eczema/Dermatitis | 1 | 65 | 1 |
| serious | Neoplasm skin | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Desloratadine: Dermal Pruritus | 0 | 29 | 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: Eczema/Dermatitis | ||
| Total, all-cause mortality | Desloratadine: Dermal Pruritus | ||
| Total, other adverse events | Desloratadine: Eczema/Dermatitis | 16 | 65 |
| Total, other adverse events | Desloratadine: Dermal Pruritus | 6 | 29 |
| Total, serious adverse events | Desloratadine: Eczema/Dermatitis | 1 | 65 |
| Total, serious adverse events | Desloratadine: Dermal Pruritus | 0 | 29 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Desloratadine: Eczema/Dermatitis vs Desloratadine: Dermal Pruritus: serious adverse events |
Source 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.
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/NCT01916980
GET https://conductscience.org/api/trials/v1/NCT01916980/results?page=2