NCT01916967

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Aug 2013

Shorter than P25 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2013

Completed
21 days until next milestone

Study Start

First participant enrolled

August 27, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2014

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2014

Completed
8 months until next milestone

Results Posted

Study results publicly available

October 30, 2014

Completed
Last Updated

June 18, 2024

Status Verified

February 1, 2022

Enrollment Period

6 months

First QC Date

August 2, 2013

Results QC Date

October 24, 2014

Last Update Submit

June 5, 2024

Conditions

Urticaria

Keywords

UrticariaSkin Diseases, VascularSkin DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesCholinergic AntagonistsCholinergic AgentsNeurotransmitter AgentsHistamine H1 Antagonists, Non-SedatingHistamine H1 AntagonistsHistamine AntagonistsHistamine Agents

Outcome Measures

Primary Outcomes (3)

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

    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.

    Baseline Visit and Week 2 Visit

  • Number of Participants Who Experienced at Least One Adverse Event (AE)

    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.

    Up to 4 weeks (Up to 2 weeks after last dose of study drug)

  • Number of Participants Who Discontinued Study Drug Due to an AE

    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.

    Up to 2 weeks

Secondary Outcomes (8)

  • 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

  • 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

  • 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

  • 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

  • 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

  • +3 more secondary outcomes

Study Arms (3)

Desloratadine 5 mg

EXPERIMENTAL

Participants receive desloratadine 5 mg, as one 5-mg tablet and one placebo tablet, orally, once daily in the evening for 2 weeks

Drug: DesloratadineDrug: Placebo

Desloratadine 10 mg

EXPERIMENTAL

Participants receive desloratadine 10 mg, as two 5-mg tablets, orally, once daily in the evening for 2 weeks

Drug: Desloratadine

Placebo

PLACEBO COMPARATOR

Participants receive placebo, as two tablets, orally, once daily in the evening for 2 weeks

Drug: Placebo

Interventions

DesloratadineDRUG

Desloratadine 5 mg tablets, given orally, once daily in the evening for 2 weeks

Desloratadine 10 mgDesloratadine 5 mg
PlaceboDRUG

Placebo tablets, given orally, once daily in the evening for 2 weeks

Desloratadine 5 mgPlacebo

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic urticaria \[rash (erythema, wheal) for more than 1 month without any known cause\]
  • Out-patient

You may not qualify if:

  • Stimulation-induced urticaria \[physical urticaria (e.g. cold, solar, and heat urticaria), cholinergic urticaria, contact urticaria)\]
  • Hypersensitivity to antihistamines or ingredients of a study drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Hide M, Maeda Y, Oshima N, Hisada S. A Phase III clinical trial of desloratadine in Japanese subjects with chronic urticaria: A randomized controlled trial. J Clin Therapeut Med. 2016;32(11):891-903.. [in Japanese] https://mol.medicalonline.jp/archive/search?jo=an9cltmd&ye=2016&vo=32&issue=11

    RESULT

MeSH Terms

Conditions

UrticariaSkin Diseases, VascularSkin DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Interventions

desloratadine

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp.
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

Study Officials

  • Medical Director

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2013

First Posted

August 6, 2013

Study Start

August 27, 2013

Primary Completion

February 28, 2014

Study Completion

March 13, 2014

Last Updated

June 18, 2024

Results First Posted

October 30, 2014

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share