Trial · NCT01916967

An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)

NCT01916967, Phase 3, Completed, Organon and Co; results first posted 2014-10-30

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201). Trials, record NCT01916967. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01916967

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An Efficacy and Safety Study of Desloratadine (MK-4117) in Japanese Participants With Chronic Urticaria (MK-4117-201)
NCT number: NCT01916967
Status: Completed
Phases: Phase 3
Enrollment: 239 participants, actual
Lead sponsor: Organon and Co
Conditions: Urticaria
Interventions: Desloratadine, Placebo
First posted: 2013-08-06
Last updated: 2024-06-18
Results first posted: 2014-10-30

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 the Sum Score of Pruritus/Itch and Rash Assessed by 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 score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The change from Baseline in the sum of the pruritus/itch and overall rash scores at the Week 2 clinic visit was calculated.
Primary	Number of Participants Who Experienced at Least One Adverse Event (AE)	Up to 4 weeks (Up to 2 weeks after last 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	Number of Participants Who Discontinued Study Drug Due to an AE	Up to 2 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 the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1	Baseline Visit and Day 3 Visit, Week 1 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 score used for pruritus/itch was the higher of the day or night scores (0=Asymptomatic to 4=Severe). The Investigator also assessed the severity of participant rash using the overall rash score (0=No rash to 3=Looks very bad). The sum of the pruritus/itch score (0-4) and rash score (0-3) could range from 0 to 7, with a higher sum score indicating greater severity. The changes from Baseline in the sum of the pruritus/itch and overall rash scores at the Day 3 and Week 1 clinic visits were calculated.
Secondary	Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2	Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit	The Investigator assessed the severity of participant pruritus/itch during the daytime and nighttime (0=Asymptomatic to 4=Severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated.
Secondary	Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2	Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit	The Investigator assessed the severity of participant rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated.
Secondary	Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2	Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit	The global improvement judgment criteria were used to assess overall improvement in pruritus/itch and rash. The Investigator assessed participant global improvement according to 5 grades (Grade 1=Remarkable improvement to Grade 5=Aggravated). The number of participants with moderate or remarkable improvements was calculated. Remarkable improvement (Grade 1) was defined as both pruritus/itch and rash (erythema and wheal) disappeared, or pruritus/itch disappeared and rash (erythema and wheal) was apparently improved. Moderate improvement (Grade 2) was defined as both pruritus/itch and rash (erythema and wheal) were greatly improved.
Secondary	Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2	Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit	Participants assessed the severity of their pruritus/itch during the daytime and nighttime (0=asymptomatic to 4=severe). The sum of the daytime and nighttime pruritus/itch scores could range from 0 to 8, with a higher score indicating greater severity. The changes from Baseline in the sum of the daytime and nighttime scores at the Day 3, Week 1 and Week 2 clinic visits were calculated.
Secondary	Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2	Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit	Participants assessed the degree of their pruritus/itching using a 100-mm visual analog scale (VAS) (0 mm=No itch to 100 mm=Worst imaginable itch), with a higher score indicating more severe itching. The changes from Baseline in participant-assessed pruritus/itch at the Day 3, Week 1 and Week 2 clinic visits were calculated.
Secondary	Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2	Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit	Participants assessed the severity of their rash (erythema: 0=no symptom to 3=intensive redness, and wheal: 0=no symptom to 3=significant ridge). The sum score for erythema plus wheal could range from 0 to 6, with a higher score indicating greater severity. The changes from Baseline in the sum score for erythema plus wheal at the Day 3, Week 1 and Week 2 clinic visits were calculated.

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

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 the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2	Baseline Visit and Week 2 Visit	The Full Analysis Set (FAS) population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and a Week 2 assessment for this outcome measure.	Score on a Scale	LEAST_SQUARES_MEAN
PRIMARY	Number of Participants Who Experienced at Least One Adverse Event (AE)	Up to 4 weeks (Up to 2 weeks after last dose of study drug)	The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.	Participants	NUMBER
PRIMARY	Number of Participants Who Discontinued Study Drug Due to an AE	Up to 2 weeks	The Safety Population consisted of all participants who received at least one dose of study drug. One Placebo group participant took the wrong study drug. This participant was analyzed separately.	Participants	NUMBER
SECONDARY	Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1	Baseline Visit and Day 3 Visit, Week 1 Visit	The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.	Score on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2	Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit	The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.	Score on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2	Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit	The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.	Score on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Number of Participants With a Moderate or Remarkable Improvement in the Global Improvement Rate of Both Pruritus/Itch and Rash (Erythema and Wheal) Assessed by the Investigator at Day 3, Week 1 and Week 2	Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit	The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.	Participants	NUMBER
SECONDARY	Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2	Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit	The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.	Score on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2	Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit	The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.	Score on a Scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2	Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit	The FAS population consisted of all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post-Baseline assessment for this outcome measure.	Score on a Scale	LEAST_SQUARES_MEAN

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group77

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2	Desloratadine 5 mg	-3.19	95% Confidence Interval -3.56 to -2.83	Score on a Scale
Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2	Desloratadine 10 mg	-3.16	95% Confidence Interval -3.52 to -2.79	Score on a Scale
Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2	Placebo	-2.02	95% Confidence Interval -2.40 to -1.65	Score on a Scale
Number of Participants Who Experienced at Least One Adverse Event (AE)	Desloratadine 5 mg	24		Participants
Number of Participants Who Experienced at Least One Adverse Event (AE)	Desloratadine 10 mg	18		Participants
Number of Participants Who Experienced at Least One Adverse Event (AE)	Placebo	16		Participants
Number of Participants Who Experienced at Least One Adverse Event (AE)	Desloratadine 5 mg→Placebo	0		Participants
Number of Participants Who Discontinued Study Drug Due to an AE	Desloratadine 5 mg	0		Participants
Number of Participants Who Discontinued Study Drug Due to an AE	Desloratadine 10 mg	0		Participants
Number of Participants Who Discontinued Study Drug Due to an AE	Placebo	2		Participants

1 to 10 of 77Source ClinicalTrials.gov

See all 77 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Desloratadine 5 mg	80
Overall Study	STARTED	Desloratadine 10 mg	79
Overall Study	STARTED	Placebo	80
Overall Study	COMPLETED	Desloratadine 5 mg	80
Overall Study	COMPLETED	Desloratadine 10 mg	78
Overall Study	COMPLETED	Placebo	71
Overall Study	NOT COMPLETED	Desloratadine 5 mg	0
Overall Study	NOT COMPLETED	Desloratadine 10 mg	1
Overall Study	NOT COMPLETED	Placebo	9

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 5 mg	8	80	8
other	Nasopharyngitis	Infections and infestations	Desloratadine 10 mg	3	79	3
other	Nasopharyngitis	Infections and infestations	Placebo	2	79	2
other	Nasopharyngitis	Infections and infestations	Desloratadine 5 mg→Placebo	0	1	0
other	Somnolence	Nervous system disorders	Desloratadine 5 mg	3	80	3
other	Somnolence	Nervous system disorders	Desloratadine 10 mg	5	79	6
other	Somnolence	Nervous system disorders	Placebo	3	79	3
other	Somnolence	Nervous system disorders	Desloratadine 5 mg→Placebo	0	1	0

Source ClinicalTrials.gov

Adverse event totals12

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, all-cause mortality	Desloratadine 5 mg→Placebo
Total, other adverse events	Desloratadine 5 mg	10	80
Total, other adverse events	Desloratadine 10 mg	8	79
Total, other adverse events	Placebo	5	79
Total, other adverse events	Desloratadine 5 mg→Placebo	0	1
Total, serious adverse events	Desloratadine 5 mg	0	80
Total, serious adverse events	Desloratadine 10 mg	0	79

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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

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