NCT01916967

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

Completed Phase 3 Results posted Last updated 18 June 2024

What this trial tests

Phase 3 trial testing Desloratadine in Urticaria in 239 participants. Completed in 13 March 2014.

Timeline

27 August 2013

Primary endpoint
28 February 2014

13 March 2014

Quick facts

Lead sponsor	Organon and Co
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	239
Start date	27 August 2013
Primary completion	28 February 2014
Estimated completion	13 March 2014

Drugs / interventions tested

• Desloratadine (desloratadine) — full drug profile →
• Placebo

Conditions studied

• Urticaria — all drugs for Urticaria →

Sponsor

Organon and Co — full company profile →

Who can join

12 and older, any sex, with Urticaria. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Week 2 Primary · 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 seve

Group	Value	95% CI
Desloratadine 5 mg	-3.19	-3.56 – -2.83
Desloratadine 10 mg	-3.16	-3.52 – -2.79
Placebo	-2.02	-2.40 – -1.65

Number of Participants Who Experienced at Least One Adverse Event (AE) Primary · 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.

Group	Value	95% CI
Desloratadine 5 mg	24
Desloratadine 10 mg	18
Placebo	16
Desloratadine 5 mg→Placebo	0

Number of Participants Who Discontinued Study Drug Due to an AE Primary · 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.

Group	Value	95% CI
Desloratadine 5 mg	0
Desloratadine 10 mg	0
Placebo	2
Desloratadine 5 mg→Placebo	0

Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1 Secondary · 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 seve

Change from Baseline at Day 3

Group	Value	95% CI
Desloratadine 5 mg	-2.57	-2.91 – -2.23
Desloratadine 10 mg	-2.75	-3.09 – -2.41
Placebo	-0.80	-1.14 – -0.46

Change from Baseline at Week 1

Group	Value	95% CI
Desloratadine 5 mg	-3.01	-3.34 – -2.68
Desloratadine 10 mg	-3.16	-3.50 – -2.83
Placebo	-1.39	-1.72 – -1.06

Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2 Secondary · 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.

Change from Baseline at Day 3

Group	Value	95% CI
Desloratadine 5 mg	-2.62	-2.97 – -2.27
Desloratadine 10 mg	-2.72	-3.07 – -2.37
Placebo	-0.61	-0.95 – -0.26

Change from Baseline at Week 1

Group	Value	95% CI
Desloratadine 5 mg	-2.98	-3.35 – -2.61
Desloratadine 10 mg	-3.13	-3.50 – -2.76
Placebo	-1.38	-1.75 – -1.01

Change from Baseline at Week 2

Group	Value	95% CI
Desloratadine 5 mg	-3.17	-3.56 – -2.77
Desloratadine 10 mg	-3.21	-3.60 – -2.81
Placebo	-1.91	-2.31 – -1.50

Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2 Secondary · 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.

Change from Baseline at Day 3

Group	Value	95% CI
Desloratadine 5 mg	-2.31	-2.63 – -2.00
Desloratadine 10 mg	-2.61	-2.93 – -2.29
Placebo	-0.99	-1.31 – -0.67

Change from Baseline at Week 1

Group	Value	95% CI
Desloratadine 5 mg	-2.65	-2.97 – -2.33
Desloratadine 10 mg	-2.98	-3.30 – -2.66
Placebo	-1.44	-1.76 – -1.12

Change from Baseline at Week 2

Group	Value	95% CI
Desloratadine 5 mg	-2.94	-3.28 – -2.61
Desloratadine 10 mg	-2.91	-3.25 – -2.57
Placebo	-1.98	-2.33 – -1.64

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 Secondary · 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 (eryt

Day 3

Group	Value	95% CI
Desloratadine 5 mg	54
Desloratadine 10 mg	55
Placebo	15

Week 1

Group	Value	95% CI
Desloratadine 5 mg	54
Desloratadine 10 mg	58
Placebo	32

Week 2

Group	Value	95% CI
Desloratadine 5 mg	59
Desloratadine 10 mg	53
Placebo	38

Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 Secondary · 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.

Change from Baseline at Day 3

Group	Value	95% CI
Desloratadine 5 mg	-2.37	-2.74 – -2.00
Desloratadine 10 mg	-2.73	-3.10 – -2.36
Placebo	-0.50	-0.87 – -0.13

Change from Baseline at Week 1

Group	Value	95% CI
Desloratadine 5 mg	-2.53	-2.91 – -2.15
Desloratadine 10 mg	-2.85	-3.24 – -2.47
Placebo	-1.27	-1.65 – -0.88

Change from Baseline at Week 2

Group	Value	95% CI
Desloratadine 5 mg	-2.85	-3.30 – -2.41
Desloratadine 10 mg	-2.97	-3.42 – -2.51
Placebo	-1.75	-2.23 – -1.27

Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2 Secondary · 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.

Change from Baseline at Day 3

Group	Value	95% CI
Desloratadine 5 mg	-35.94	-41.91 – -29.97
Desloratadine 10 mg	-39.60	-45.61 – -33.60
Placebo	-5.22	-11.19 – 0.75

Change from Baseline at Week 1

Group	Value	95% CI
Desloratadine 5 mg	-40.82	-46.55 – -35.09
Desloratadine 10 mg	-48.82	-54.60 – -43.03
Placebo	-15.88	-21.63 – -10.13

Change from Baseline at Week 2

Group	Value	95% CI
Desloratadine 5 mg	-45.86	-51.96 – -39.75
Desloratadine 10 mg	-45.01	-51.17 – -38.84
Placebo	-25.24	-31.52 – -18.97

Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 Secondary · 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.

Change from Baseline at Day 3

Group	Value	95% CI
Desloratadine 5 mg	-2.21	-2.57 – -1.85
Desloratadine 10 mg	-2.31	-2.67 – -1.94
Placebo	-0.77	-1.13 – -0.40

Change from Baseline at Week 1

Group	Value	95% CI
Desloratadine 5 mg	-2.15	-2.50 – -1.81
Desloratadine 10 mg	-2.43	-2.77 – -2.08
Placebo	-1.17	-1.52 – -0.83

Change from Baseline at Week 2

Group	Value	95% CI
Desloratadine 5 mg	-2.51	-2.88 – -2.13
Desloratadine 10 mg	-2.45	-2.83 – -2.06
Placebo	-1.70	-2.11 – -1.29

Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2 Secondary · Baseline Visit and Week 1 Visit, Week 2 Visit

The DLQI is a 10-item questionnaire that measures how much participant skin problems have affected their life. Responses to questions about the effect of participant skin problems on life ranged from 0=Not at all to 3=Very much. The DLQI is broken down into 6 subscales: Symptoms and feelings (range 0-6), Daily activities (range 0-6), Leisure (range 0-6), Work and school (range 0-3), Personal relationships (range 0-6), and Treatment (range 0-3). DLQI subscales were summed to yield the DLQI total score, which could range from 0 to 30. For both DLQI subscales and DLQI total score, a higher score

Change from Baseline at Week 1

Group	Value	95% CI
Desloratadine 5 mg	-3.82	-4.52 – -3.12
Desloratadine 10 mg	-4.08	-4.78 – -3.37
Placebo	-1.60	-2.31 – -0.89

Change from Baseline at Week 2

Group	Value	95% CI
Desloratadine 5 mg	-4.10	-4.83 – -3.38
Desloratadine 10 mg	-4.01	-4.74 – -3.28
Placebo	-2.53	-3.28 – -1.78

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 4 weeks (Up to 2 weeks after last dose of study drug). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Desloratadine 5 mg

Serious: 0/80 (0%)

Deaths: —

Desloratadine 10 mg

Serious: 0/79 (0%)

Deaths: —

Placebo

Serious: 0/79 (0%)

Deaths: —

Desloratadine 5 mg→Placebo

Serious: 0/1 (0%)

Deaths: —

Other adverse events (2 terms — click to expand)

Reaction	System	Desloratadine 5 mg	Desloratadine 10 mg	Placebo	Desloratadine 5 mg→Placebo
Nasopharyngitis	Infections and infestations	—	—	—	—
Somnolence	Nervous system disorders	—	—	—	—

Data from ClinicalTrials.gov NCT01916967 adverse events section.

Sponsor's own description

This is a study to evaluate the efficacy and safety of desloratadine (MK-4117) in Japanese participants with chronic urticaria. The primary hypothesis is that the efficacy of desloratadine 10 mg and 5 mg is superior to placebo as based on the change from Baseline in the sum score of pruritus/itch and rash as assessed by the Investigator at Week 2.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.