Clinical Trial Results:
A Phase III, multicentre, parallel-group, randomized, placebo-controlled, double-blind clinical trial
to study the efficacy and safety of desloratadine in Japanese subjects with chronic urticaria
Summary
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EudraCT number |
2017-000608-13 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
13 Mar 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
09 Apr 2017
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First version publication date |
09 Apr 2017
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
4117-201
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01916967 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Merck Sharp & Dohme Corp.
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Sponsor organisation address |
2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
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Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
13 Mar 2014
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Mar 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
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.
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Protection of trial subjects |
This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
27 Aug 2013
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Japan: 239
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Worldwide total number of subjects |
239
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
11
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Adults (18-64 years) |
205
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From 65 to 84 years |
23
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||||||||||
Pre-assignment
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Screening details |
Participants with chronic urticaria of at least 12 years of age were enrolled in this trial. | ||||||||||||||||||||||||||||||||
Period 1
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Period 1 title |
Period 1 (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Double blind | ||||||||||||||||||||||||||||||||
Roles blinded |
Subject, Investigator | ||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Desloratadine 5 mg | ||||||||||||||||||||||||||||||||
Arm description |
Participants received desloratadine 5 mg, as one 5 mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks | ||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Desloratadine
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Investigational medicinal product code |
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Other name |
MK-4117
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
5 mg Desloratadine administered orally once daily for 2 weeks
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Arm title
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Desloratadine 10 mg | ||||||||||||||||||||||||||||||||
Arm description |
Participants received desloratadine 10 mg, as two 5 mg tablets, orally, once daily in the evening for 2 weeks | ||||||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Desloratadine
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Investigational medicinal product code |
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Other name |
MK-4117
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
10 mg Desloratadine administered orally once daily for 2 weeks
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Arm title
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Placebo | ||||||||||||||||||||||||||||||||
Arm description |
Participants received placebo, as two tablets, orally, once daily in the evening for 2 weeks | ||||||||||||||||||||||||||||||||
Arm type |
Placebo | ||||||||||||||||||||||||||||||||
Investigational medicinal product name |
Placebo
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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Dosage and administration details |
Placebo for Desloratadine administered orally once daily for 2 weeks
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Baseline characteristics reporting groups
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Reporting group title |
Desloratadine 5 mg
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Reporting group description |
Participants received desloratadine 5 mg, as one 5 mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Desloratadine 10 mg
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Reporting group description |
Participants received desloratadine 10 mg, as two 5 mg tablets, orally, once daily in the evening for 2 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Participants received placebo, as two tablets, orally, once daily in the evening for 2 weeks | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Desloratadine 5 mg
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Reporting group description |
Participants received desloratadine 5 mg, as one 5 mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks | ||
Reporting group title |
Desloratadine 10 mg
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Reporting group description |
Participants received desloratadine 10 mg, as two 5 mg tablets, orally, once daily in the evening for 2 weeks | ||
Reporting group title |
Placebo
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Reporting group description |
Participants received placebo, as two tablets, orally, once daily in the evening for 2 weeks | ||
Subject analysis set title |
Desloratadine 5 mg
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants received desloratadine 5 mg, as one 5 mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks
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Subject analysis set title |
Desloratadine 10 mg
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants received desloratadine 10 mg, as two 5 mg tablets, orally, once daily in the evening for 2 weeks
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Subject analysis set title |
Placebo
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participants received placebo, as two tablets, orally, once daily in the evening for 2 weeks
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Subject analysis set title |
Desloratadine 5 mg→Placebo
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
Participant received desloratadine 5 mg, as one 5 mg tablet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week
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End point title |
Change from baseline in the sum score of pruritus/itch and rash assessed by investigator at Week 2 | ||||||||||||||||
End point description |
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. The population analyzed 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.
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End point type |
Primary
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End point timeframe |
Baseline Visit and Week 2 Visit
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Statistical analysis title |
Difference LS means: Desloratadine 5 mg vs Placebo | ||||||||||||||||
Statistical analysis description |
Model with terms of visit, visit by treatment, visit by age strata, visit by severity interactions; visit treated as a categorical variable
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Comparison groups |
Desloratadine 5 mg v Placebo
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Number of subjects included in analysis |
160
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||
Method |
Constrained Longitudinal Data Analysis | ||||||||||||||||
Parameter type |
Difference in LS means | ||||||||||||||||
Point estimate |
-1.17
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Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
-1.69 | ||||||||||||||||
upper limit |
-0.65 | ||||||||||||||||
Statistical analysis title |
Difference LS means: Desloratadine 5 mg vs Placebo | ||||||||||||||||
Statistical analysis description |
Model with terms of visit, visit by treatment, visit by age strata, visit by severity interactions; visit treated as a categorical variable
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Comparison groups |
Desloratadine 10 mg v Placebo
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Number of subjects included in analysis |
159
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||||||
P-value |
< 0.001 | ||||||||||||||||
Method |
Constrained Longitudinal Data Analysis | ||||||||||||||||
Parameter type |
Difference in LS means | ||||||||||||||||
Point estimate |
-1.13
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Confidence interval |
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level |
95% | ||||||||||||||||
sides |
2-sided
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lower limit |
-1.66 | ||||||||||||||||
upper limit |
-0.61 |
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End point title |
Number of participants who experienced at least one adverse event (AE) [1] | ||||||||||||||||||||
End point description |
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 preexisting condition that is temporally associated with the use of the study drug, is also an AE. The population analyzed 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.
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End point type |
Primary
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End point timeframe |
Up to 4 weeks (Up to 2 weeks after last dose of study drug)
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint. |
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No statistical analyses for this end point |
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End point title |
Number of participants who discontinued study drug due to an AE [2] | ||||||||||||||||||||
End point description |
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 preexisting condition that is temporally associated with the use of the study drug, is also an AE. The population analyzed 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.
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End point type |
Primary
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End point timeframe |
Up to 2 weeks
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Notes [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical comparisons between treatment groups were neither planned nor performed for this primary endpoint. |
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No statistical analyses for this end point |
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End point title |
Change From Baseline in the Sum Score of Pruritus/Itch and Rash Assessed by Investigator at Day 3 and Week 1 | ||||||||||||||||||||||||
End point description |
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. The population analyzed 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.
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End point type |
Secondary
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End point timeframe |
Baseline Visit and Day 3 Visit, Week 1 Visit
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No statistical analyses for this end point |
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End point title |
Change From Baseline in the Pruritus/Itch Score Assessed by Investigator at Day 3, Week 1 and Week 2 | ||||||||||||||||||||||||||||
End point description |
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. The population analyzed 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.
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End point type |
Secondary
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End point timeframe |
Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
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No statistical analyses for this end point |
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End point title |
Change From Baseline in the Rash Score Assessed by Investigator at Day 3, Week 1 and Week 2 | ||||||||||||||||||||||||||||
End point description |
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. The population analyzed 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.
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End point type |
Secondary
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End point timeframe |
Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
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No statistical analyses for this end point |
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End point title |
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 | ||||||||||||||||||||||||||||
End point description |
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. The population analyzed 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.
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End point type |
Secondary
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End point timeframe |
Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
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No statistical analyses for this end point |
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End point title |
Change From Baseline in the Pruritus/Itch Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | ||||||||||||||||||||||||||||
End point description |
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. The population analyzed 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.
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End point type |
Secondary
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End point timeframe |
Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
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No statistical analyses for this end point |
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End point title |
Change From Baseline in Pruritus/Itch on a Visual Analog Scale (VAS) Reported by Participants at Day 3, Week 1 and Week 2 | ||||||||||||||||||||||||||||
End point description |
Participants assessed the degree of their pruritus/itching using a 100mm 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. The population analyzed 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.
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End point type |
Secondary
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End point timeframe |
Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
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No statistical analyses for this end point |
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End point title |
Change From Baseline in the Rash Score Reported in Participant Diaries at Day 3, Week 1 and Week 2 | ||||||||||||||||||||||||||||
End point description |
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. The population analyzed 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.
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End point type |
Secondary
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End point timeframe |
Baseline Visit and Day 3 Visit, Week 1 Visit, Week 2 Visit
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No statistical analyses for this end point |
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End point title |
Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score Reported by Participants at Week 1 and Week 2 | ||||||||||||||||||||||||
End point description |
The DLQI is a 10 item questionnaire measuring how much participant skin problems have affected their life. Responses to questions ranged from 0=Not at all to 3=Very much. The DLQI consists of 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 DLQI subscales and DLQI total score, a higher score indicated a greater negative impact on life. Participants >=16 years of age completed the DLQI questionnaire over the previous week. The changes from Baseline in the DLQI total score at the Week 1 and Week 2 clinic visits were calculated. The population analyzed was all randomized participants who took at least one dose of study drug, had a Baseline assessment and at least one post Baseline assessment for DLQI.
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End point type |
Secondary
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End point timeframe |
Baseline Visit and Week 1 Visit, Week 2 Visit
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Up to 4 weeks (Up to 2 weeks after last dose of study drug)
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Adverse event reporting additional description |
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.
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.1
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Reporting groups
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Reporting group title |
Desloratadine 5 mg
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Reporting group description |
Participants received desloratadine 5 mg, as one 5 mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Desloratadine 10 mg
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Reporting group description |
Participants received desloratadine 10 mg, as two 5 mg tablets, orally, once daily in the evening for 2 weeks | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Placebo
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Reporting group description |
Participants received placebo, as two tablets, orally, once daily in the evening for 2 weeks | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Desloratadine 5 mg→Placebo
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Reporting group description |
Participant received desloratadine 5 mg, as one 5 mg tablet and one placebo tablet, orally, once daily for 1 week and then received placebo, as two tablets, orally, once daily for 1 week | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |