Chronic UrticariaPhase 2NCT06268470
Antiplatelet Therapy in Chronic Urticaria
A Phase 2 study testing Desloratadine plus cilostazol and dipyridamole and Desloratadine in people with Chronic Urticaria, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
This study compares the combination of antiplatelets and antihistamine versus antihistamine alone for the treatment of chronic spontaneous urticaria Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Urticaria
- What is being tested?
- Desloratadine plus cilostazol and dipyridamole and Desloratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jun 2018to 1 May 2024
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic spontaneous urticaria
- D-dimer levels over 500 ng/ml
- Not respond to a conventional dose of antihistamine
Who cannot join
- Are taking aspirin
- Have bleeding tendency
- Have concurrent severe medical illnesses
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Chronic Urticaria
- Being tested
- Desloratadine plus cilostazol and dipyridamole, Desloratadine
- Keywords
- Chronic urticaria, antiplatelet, D-dimer
- Medical subject headings
- Chronic Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desloratadine plus cilostazol and dipyridamoleDrug
Also called Antihistamine plus antiplatelets
Desloratadine 20 mg/day plus cilostazol 150 mg/day and dipyridamole 50 mg/day
DesloratadineDrug
Also called Antihistamine alone
Desloratadine 20 mg/day
| Study group | Role | What they receive |
|---|---|---|
| Desloratadine | Active comparator | Oral desloratadine 20 mg/day (antihistamine) for 4 weeks Receives: Drug: Desloratadine |
| Desloratadine plus cilostazol and dipyridamole | Experimental | Oral desloratadine 20 mg/day (antihistamine) in conjunction with cilostazol 150 mg/day and dipyridamole 50 mg/day (antiplatelets) for 4 weeks Receives: Drug: Desloratadine plus cilostazol and dipyridamole; Drug: Desloratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly urticaria activity score
Urticaria activity score over 7 days (UAS7): scores 0-42 from mild to severe
Measured: 4 weeks
Secondary outcomes (1)
D-dimer levels
D-dimer levels
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start1 Jun 2018
- Primary completion1 Mar 2024 (estimated)
- Study completion1 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients diagnosed with chronic urticaria will be assigned to 2 treatment arms. 1. high dose antihistamine with antiplatelets; and 2. high dose antihistamine alone.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. Prof. Jettanong Klaewsongkram, MD., Chulalongkorn University
- Investigators
- Jettanong Klaewsongkram, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06268470
- Sponsor's protocol ID
- Chula-ARC 001/18
- Status last verified
- Feb 2024
- First submitted
- 13 Feb 2024
- Last updated
- 21 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Antiplatelet Therapy for the Treatment of Chronic Recalcitrant Urticaria
- ClinicalTrials.gov ID
- NCT06268470
- Acronym / sponsor ID
- Chula-ARC 001/18
- Conditions
- Chronic Urticaria
- Keywords
- Chronic urticaria, antiplatelet, D-dimer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Mar 2024 (estimated)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 20 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study compares the combination of antiplatelets and antihistamine versus antihistamine alone for the treatment of chronic spontaneous urticaria
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients diagnosed with chronic urticaria will be assigned to 2 treatment arms. 1. high dose antihistamine with antiplatelets; and 2. high dose antihistamine alone.
| Arm | Type | Receives |
|---|---|---|
| Desloratadine | Active comparator | Drug: DesloratadineOral desloratadine 20 mg/day (antihistamine) for 4 weeks |
| Desloratadine plus cilostazol and dipyridamole | Experimental | Drug: Desloratadine plus cilostazol and dipyridamole, Drug: DesloratadineOral desloratadine 20 mg/day (antihistamine) in conjunction with cilostazol 150 mg/day and dipyridamole 50 mg/day (antiplatelets) for 4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Chronic spontaneous urticaria
- D-dimer levels over 500 ng/ml
- Not respond to a conventional dose of antihistamine
Key exclusion criteria (4 listed)
- Are taking aspirin
- Have bleeding tendency
- Have concurrent severe medical illnesses
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desloratadine plus cilostazol and dipyridamoleAlso: Antihistamine plus antiplateletsDesloratadine 20 mg/day plus cilostazol 150 mg/day and dipyridamole 50 mg/day | Drug | Desloratadine plus cilostazol and dipyridamole |
| DesloratadineAlso: Antihistamine aloneDesloratadine 20 mg/day | Drug | Desloratadine, Desloratadine plus cilostazol and dipyridamole |
Primary outcome
Weekly urticaria activity score
Time frame: 4 weeks
Urticaria activity score over 7 days (UAS7): scores 0-42 from mild to severe
1 secondary outcome
D-dimer levels
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jettanong Klaewsongkram, MD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Desloratadine plus cilostazol and dipyridamole and Desloratadine in people with Chronic Urticaria, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly urticaria activity score (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.