Clinical Trial Results:
A Phase III, multicenter, open-label, long-term trial to study the efficacy and safety of MK-4117 in Japanese subjects with eczema/dermatitis and dermal pruritus
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Summary
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EudraCT number |
2017-000610-26 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
22 Mar 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
12 May 2017
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First version publication date |
12 May 2017
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Other versions |
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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 |
4117-202
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01916980 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
JAPIC-CTI: 132245 | ||
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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 |
22 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 |
22 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 was an efficacy and safety study of up to 12 weeks of MK-4117 (desloratadine) in Japanese participants with eczema/dermatitis or dermal pruritus. The primary hypothesis of this study is that the sum of the daytime and nighttime pruritus/itch scores for both the eczema/dermatitis group and the dermal pruritus group will be significantly improved at Week 2 compared to Baseline.
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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: 94
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Worldwide total number of subjects |
94
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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) |
14
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Adults (18-64 years) |
70
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From 65 to 84 years |
9
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85 years and over |
1
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Recruitment
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Recruitment details |
Japanese participants of at least 12 years of age with eczema/dermatitis or dermal pruritus were recruited. | |||||||||||||||||||||
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Pre-assignment
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Screening details |
The screening period lasted up to 2 weeks. A total of 99 participants were screened and 94 were enrolled. | |||||||||||||||||||||
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Period 1
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Period 1 title |
Treatment (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | |||||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Desloratadine: Eczema/Dermatitis | |||||||||||||||||||||
Arm description |
Participants with eczema/dermatitis received desloratadine 5 mg (taken as one 5-mg tablet) by mouth once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine could have been increased from 5 mg/day to 10 mg/day (taken as two 5-mg tablets) by mouth once daily in the evening for up to 8 weeks, if criteria for dose up-titration were met, there was insufficient anti-pruritic efficacy and there was no safety concern. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Desloratadine 5 mg tablet
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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 |
One desloratadine 5 mg tablet taken by mouth in the evening (dose could have increased to two 5 mg tablets after Week 4).
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Arm title
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Desloratadine: Dermal Pruritis | |||||||||||||||||||||
Arm description |
Participants with dermal pruritus received desloratadine 5 mg (taken as one 5-mg tablet) by mouth once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine could have been increased from 5 mg/day to 10 mg/day (taken as two 5-mg tablets) by mouth once daily in the evening for up to 8 weeks, if criteria for dose up-titration were met, there was insufficient anti-pruritic efficacy and there was no safety concern. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Desloratadine 5 mg tablet
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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 |
One desloratadine 5 mg tablet taken by mouth in the evening (dose could have increased to two 5 mg tablets after Week 4).
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Baseline characteristics reporting groups
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Reporting group title |
Desloratadine: Eczema/Dermatitis
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Reporting group description |
Participants with eczema/dermatitis received desloratadine 5 mg (taken as one 5-mg tablet) by mouth once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine could have been increased from 5 mg/day to 10 mg/day (taken as two 5-mg tablets) by mouth once daily in the evening for up to 8 weeks, if criteria for dose up-titration were met, there was insufficient anti-pruritic efficacy and there was no safety concern. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Desloratadine: Dermal Pruritis
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Reporting group description |
Participants with dermal pruritus received desloratadine 5 mg (taken as one 5-mg tablet) by mouth once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine could have been increased from 5 mg/day to 10 mg/day (taken as two 5-mg tablets) by mouth once daily in the evening for up to 8 weeks, if criteria for dose up-titration were met, there was insufficient anti-pruritic efficacy and there was no safety concern. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Desloratadine: Eczema/Dermatitis
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Reporting group description |
Participants with eczema/dermatitis received desloratadine 5 mg (taken as one 5-mg tablet) by mouth once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine could have been increased from 5 mg/day to 10 mg/day (taken as two 5-mg tablets) by mouth once daily in the evening for up to 8 weeks, if criteria for dose up-titration were met, there was insufficient anti-pruritic efficacy and there was no safety concern. | ||
Reporting group title |
Desloratadine: Dermal Pruritis
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Reporting group description |
Participants with dermal pruritus received desloratadine 5 mg (taken as one 5-mg tablet) by mouth once daily in the evening for up to 12 weeks. After Week 4, the dose of desloratadine could have been increased from 5 mg/day to 10 mg/day (taken as two 5-mg tablets) by mouth once daily in the evening for up to 8 weeks, if criteria for dose up-titration were met, there was insufficient anti-pruritic efficacy and there was no safety concern. | ||
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End point title |
Change From Baseline in Pruritus/Itch Score (Sum of Daytime and Nighttime Scores) Assessed by the Investigator at Week 2 [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 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. 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.
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End point type |
Primary
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End point timeframe |
Baseline Visit and Week 2
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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: Per protocol, only descriptive statistics are presented. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Participants Who Experienced at Least One Adverse Event (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 pre-existing condition that is temporally associated with the use of the study drug is also an AE. The All-Participants-as-Treated (APaT) population consisted of all participants who received at least one dose of study drug.
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End point type |
Primary
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End point timeframe |
Up to 14 weeks (up to 2 weeks after the last dose of study drug)
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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: Per protocol, only descriptive statistics are presented. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
Percentage of Participants Who Discontinued Study Drug Due to an AE [3] | ||||||||||||
End point description |
An adverse event is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. 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 APaT population consisted of all participants who received at least one dose of study drug.
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End point type |
Primary
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End point timeframe |
Up to 12 weeks
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| Notes [3] - 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: Per protocol, only descriptive statistics are presented. |
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| No statistical analyses for this end point | |||||||||||||
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End point title |
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 | ||||||||||||||||||||||||||||||
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 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. 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.
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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 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 Visit
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||
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End point title |
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 | |||||||||||||||||||||||||||||||||
End point description |
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. 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.
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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, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 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 Visual Analog Scale (VAS) Score Recorded by Participants at Day 3, Week 1, Week 2, Week 4, Week 6, Week 8 and Week 12 | |||||||||||||||||||||||||||||||||
End point description |
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. 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.
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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, Week 4 Visit, Week 6 Visit, Week 8 Visit, Week 12 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 14 weeks (up to 2 weeks after the last dose of study drug)
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Assessment type |
Systematic | |||||||||||||||||||||||||||||||||||||||||||||
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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 |
Eczema/Dermatitis
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Reporting group description |
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Reporting group title |
Dermal Pruritus
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Reporting group description |
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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 | |||
