UrticariaPhase 4AECUDATTNCT01444196
Desloratadine 5, 10 and 20mg in Patients With Cold Urticaria
A Phase 4 study testing Desloratadine in people with Urticaria, run by Marcus Maurer at 1 site in Germany.
Trial summary
The primary objective of the study is to assess the dosis of DL which is sufficient to inhibit cold urticaria symptoms. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Urticaria
- What is being tested?
- Desloratadine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to May 2010
- Phase
- Phase 4
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent signed and dated
- Reliable method of contraception for both women of childbearing potential as well as man during the study and 3 months thereafter. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner
- Outpatients with ACU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
- Age between 18 and 75 years
Who cannot join
- Subjects who are inmates of psychiatric wards, prisons, or other state institutions. Existing or planned placement in an institution after ruling according to § 40 passage 1 number 4 AMG (Arzneimittelgesetz).
- The presence of permanent severe diseases, especially those affecting the immune system, except urticaria and cold urticaria
- The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract)
- History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
- History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy
- Evidence of severe renal dysfunction
Show all 14Show fewer
- Evidence of significant hepatic disease (liver enzymes twice the upper reference value)
- History of adverse reactions to DL
- Presence of active cancer which requires chemotherapy or radiation therapy
- Presence of alcohol abuse or drug addiction
- Intake of oral corticosteroids within 14 days prior to screening visit
- Use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior to screening visit
- Use of systemic immunosupressants/immunomodulators like ciclosporine A, dapsone, methotrexate, mycophenolate, chloroquine, and comparable drugs within 28 days prior to screening visit.
- Pregnancy or breast-feeding
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Dermatology, Venerology and Allergology
Berlin, State of Berlin, 10117
About this study
Official title: Multi-center, Double Blind, Dose Escalating Study to Compare the Effects of 5 mg, 10mg and 20mg of Desloratadine in Patients With Acquired Cold Urticaria (ACU)
The primary objective of the study is to assess the dosis of DL which is sufficient to inhibit cold urticaria symptoms.
Read the detailed description
A total of 30 patients (male and female) with ACU will be included in this study
- Conditions
- Urticaria
- Being tested
- Desloratadine
- Keywords
- ACU, acquired cold urticaria
- Medical subject headings
- Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DesloratadineDrug
Also called No arm names.
Every day,per mouth,in the evening, for 14 +- 2 days.
| Study group | Role | What they receive |
|---|---|---|
| Desloratadine dose | Other | 1. Study group: 5 mg Desloratadine during the whole study
2. Study group: 5 mg every day for 14 (+-2 days) start with Visit 2, 10 mg every day for 14 (+-2 days) start with Visit 3, 20 mg every day for 14 (+-2 days) start with Visit 4. Receives: Drug: Desloratadine |
| Dose of Desloratadine | Other | 1. Study group: 5 mg Desloratadine during the whole study
2. Study group: 5 mg every day for 14 (+-2 days) start with Visit 2, 10 mg every day for 14 (+-2 days) start with Visit 3, 20 mg every day for 14 (+-2 days) start with Visit 4. Receives: Drug: Desloratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTTs and CSTTs assessed by TEMPtest 3.0 + urticaria network SOPs
Measured: 6 weeks
Secondary outcomes (1)
Presence of wheal(s) at 4°C Intensity of pruritus and burning Number and duration of angioedemas QoL as assessed by DLQI Severity of ACU (by ACUSI)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2011 (estimated)
- Study startAug 2009
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marcus Maurer
- Sponsor type
- University, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz
- Responsible party
- Sponsor-investigator, Marcus Maurer, Charite University, Berlin, Germany
- Investigators
- Marcus Maurer, Prof., Principal investigator, Charite, University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01444196
- Sponsor's protocol ID
- 2008-005746-22
- Other IDs
- 2008-005746-22, 2008
- Acronym
- AECUDATT
- Status last verified
- Sep 2011
- First submitted
- 29 Sep 2011
- Last updated
- 3 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-center, Double Blind, Dose Escalating Study to Compare the Effects of 5 mg, 10mg and 20mg of Desloratadine in Patients With Acquired Cold Urticaria (ACU)
- ClinicalTrials.gov ID
- NCT01444196
- Acronym / sponsor ID
- AECUDATT / 2008-005746-22
- Conditions
- Urticaria
- Keywords
- ACU, acquired cold urticaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Marcus MaurerUniversity, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz
- Study start
- Aug 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 30 Sep 2011 (estimated)
- 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.
The primary objective of the study is to assess the dosis of DL which is sufficient to inhibit cold urticaria symptoms.
Detailed description
A total of 30 patients (male and female) with ACU will be included in this study
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Desloratadine dose | Other | Drug: Desloratadine1. Study group: 5 mg Desloratadine during the whole study 2. Study group: 5 mg every day for 14 (+-2 days) start with Visit 2, 10 mg every day for 14 (+-2 days) start with Visit 3, 20 mg every day for 14 (+-2 days) start with Visit 4. |
| Dose of Desloratadine | Other | Drug: Desloratadine1. Study group: 5 mg Desloratadine during the whole study 2. Study group: 5 mg every day for 14 (+-2 days) start with Visit 2, 10 mg every day for 14 (+-2 days) start with Visit 3, 20 mg every day for 14 (+-2 days) start with Visit 4. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent signed and dated
- Reliable method of contraception for both women of childbearing potential as well as man during the study and 3 months thereafter. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner
- Outpatients with ACU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
- Age between 18 and 75 years
Key exclusion criteria (14 listed)
- Subjects who are inmates of psychiatric wards, prisons, or other state institutions. Existing or planned placement in an institution after ruling according to § 40 passage 1 number 4 AMG (Arzneimittelgesetz).
- The presence of permanent severe diseases, especially those affecting the immune system, except urticaria and cold urticaria
- The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract)
- History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
- History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy
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 |
|---|---|---|
| DesloratadineAlso: No arm names.Every day,per mouth,in the evening, for 14 +- 2 days. | Drug | Desloratadine dose, Dose of Desloratadine |
Primary outcome
CTTs and CSTTs assessed by TEMPtest 3.0 + urticaria network SOPs
Time frame: 6 weeks
1 secondary outcome
Presence of wheal(s) at 4°C Intensity of pruritus and burning Number and duration of angioedemas QoL as assessed by DLQI Severity of ACU (by ACUSI)
Time frame: 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2011.
- KälteurtikariaLink provided by the sponsor.
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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.
Marcus Maurer, Prof. principal investigator
Charite, University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Desloratadine in people with Urticaria, run by Marcus Maurer at 1 site in Germany.
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 4 inclusion and 14 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: finished, as of the sponsor's last update on 3 Oct 2011. 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 Germany. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CTTs and CSTTs assessed by TEMPtest 3.0 + urticaria network SOPs (time frame: 6 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 3 Oct 2011.