Antiplatelet Therapy in Chronic Urticaria

February 19, 2024 updated by: Assoc. Prof. Jettanong Klaewsongkram, MD., Chulalongkorn University

Efficacy of Antiplatelet Therapy for the Treatment of Chronic Recalcitrant Urticaria

This study compares the combination of antiplatelets and antihistamine versus antihistamine alone for the treatment of chronic spontaneous urticaria

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This study is a randomized control trial comparing the effectiveness of the combination of antiplatelets and antihistamine and antihistamine alone for the treatment of chronic spontaneous urticaria

Study Type

Interventional

Enrollment (Estimated)

12

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Faculty of Medicine, Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

Chronic spontaneous urticaria

D-dimer levels over 500 ng/ml

Not respond to a conventional dose of antihistamine

Exclusion Criteria:

Are taking aspirin

Have bleeding tendency

Have concurrent severe medical illnesses

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Desloratadine
Oral desloratadine 20 mg/day (antihistamine) for 4 weeks
Drug: Desloratadine
Desloratadine 20 mg/day
Other Names:
  • Antihistamine alone
Experimental: Desloratadine plus cilostazol and dipyridamole
Oral desloratadine 20 mg/day (antihistamine) in conjunction with cilostazol 150 mg/day and dipyridamole 50 mg/day (antiplatelets) for 4 weeks
Drug: Desloratadine
Desloratadine 20 mg/day
Other Names:
  • Antihistamine alone
Drug: Desloratadine plus cilostazol and dipyridamole
Desloratadine 20 mg/day plus cilostazol 150 mg/day and dipyridamole 50 mg/day
Other Names:
  • Antihistamine plus antiplatelets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Weekly urticaria activity score
Time Frame: 4 weeks
Urticaria activity score over 7 days (UAS7): scores 0-42 from mild to severe
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
D-dimer levels
Time Frame: 4 weeks
D-dimer levels
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Jettanong Klaewsongkram, MD, Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2018

Primary Completion (Estimated)

March 1, 2024

Study Completion (Estimated)

May 1, 2024

Study Registration Dates

First Submitted

February 13, 2024

First Submitted That Met QC Criteria

February 13, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Estimated)

February 21, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chula-ARC 001/18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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