Chronic UrticariaPhase 3AUD2OCUNCT00598611
Effects of 5 mg vs. 20 mg Desloratadine on Skin Lesions in Patients With Chronic Urticaria (CU)
A Phase 3 study testing desloratadine in people with Chronic Urticaria, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to compare urticaria lesions (size, kinetics) by thermography, volumetry and digital time lapse photography in CU patients treated with desloratadine 5 mg or desloratadine 20 mg. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Urticaria
- What is being tested?
- desloratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2007to Aug 2009
- Phase
- Phase 3
- 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
- Outpatients with moderate to severe CU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
- Patients must exhibit spontaneous urticaria lesions in the randomization visit.
- History of beneficial effects of antihistaminic treatment.
- Age between 18 and 60 years.
- Female patients must be using adequate contraceptive precautions (highly effective method), or they must be postmenopausal, surgically sterilised, or hysterectomised (for details please see protocol).
- Female patients must be using adequate contraceptive precautions (contraceptive pill, depot, double barrier methods), or they must be postmenopausal, surgically sterilised, or hysterectomised.
- Voluntarily signed written informed consent.
Who cannot join
- The presence of permanent severe diseases, especially those affecting the immune system, except CU.
- The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhea diseases, congenital malformations or surgical mutilations of the 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
- Evidence of significant hepatic disease (liver enzymes twice the upper reference value).
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- The presence of galactose intolerance, lapp lactase deficiency or glucose galactose malabsorption.
- History of adverse reactions including hypersensitivity to DL and Loratadine.
- Intake of medicaments that could cause QT changes (drugs listed on www.qtdrugs.org).
- Presence of active cancer which requires chemotherapy or radiation therapy.
- Presence of acute urticaria / angioedema including laryngeal edema
- History or presence of alcohol abuse or drug addiction.
- Participation in any clinical trial within 4 weeks prior to enrolment.
- Intake of oral corticosteroids or other immunosuppressive therapy within 14 days prior to the beginning of the study.
- Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study.
- Pregnancy or breast-feeding.
- Existing or planned placement in an institution after ruling according to § 40 passage 1 number 4 AMG (Arzneimittelgesetz).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Phase III, Randomised, Double-blind, Therapeutic Single Dose-related Effect, Parallel Group Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on Skin Lesions in Patients With Chronic Urticaria (CU)
The purpose of this study is to compare urticaria lesions (size, kinetics) by thermography, volumetry and digital time lapse photography in CU patients treated with desloratadine 5 mg or desloratadine 20 mg. Hypothesis: Updosing of desloratadine (20mg) is more efficient in the treatment of urticarial lesions as compared to standard dosing (5 mg desloratadine).
- Conditions
- Chronic Urticaria
- Being tested
- desloratadine
- Keywords
- urticaria
- Medical subject headings
- Chronic Urticaria, Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desloratadineDrug
singel dose, oral, 20 mg
desloratadineDrug
single dose, oral, 5 mg
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | desloratadine 20 mg Receives: Drug: desloratadine |
| 2 | Active comparator | desloratadine 20 mg Receives: Drug: desloratadine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by thermography.
Measured: 5 hours
Secondary outcomes (1)
Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by volumetry and digital time lapse photography.
Measured: 5 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2008 (estimated)
- Study startSep 2007
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic UrticariaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Essex Pharma GmbH
- Responsible party
- Principal investigator, K. Weller, Charite University, Berlin, Germany
- Investigators
- Marcus Maurer, MD, Principal investigator, Allergie-Centrum-Charite
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00598611
- Sponsor's protocol ID
- P04805-V2.0
- Other IDs
- EudraCT number: 2006-003686-13
- Acronym
- AUD2OCU
- Status last verified
- May 2012
- First submitted
- 10 Jan 2008
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Weller K, Ardelean E, Scholz E, Martus P, Zuberbier T, Maurer M. Can on-demand non-sedating antihistamines improve urticaria symptoms? A double-blind, randomized, single-dose study. Acta Derm Venereol. 2013 Mar 27;93(2):168-74. doi: 10.2340/00015555-1434.
PubMed 23053062
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Phase III, Randomised, Double-blind, Therapeutic Single Dose-related Effect, Parallel Group Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on Skin Lesions in Patients With Chronic Urticaria (CU)
- ClinicalTrials.gov ID
- NCT00598611
- Acronym / sponsor ID
- AUD2OCU / P04805-V2.0
- Conditions
- Chronic Urticaria
- Keywords
- urticaria
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Essex Pharma GmbH
- Study start
- Sep 2007
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 22 Jan 2008 (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 purpose of this study is to compare urticaria lesions (size, kinetics) by thermography, volumetry and digital time lapse photography in CU patients treated with desloratadine 5 mg or desloratadine 20 mg. Hypothesis: Updosing of desloratadine (20mg) is more efficient in the treatment of urticarial lesions as compared to standard dosing (5 mg desloratadine).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: desloratadinedesloratadine 20 mg |
| 2 | Active comparator | Drug: desloratadinedesloratadine 20 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Outpatients with moderate to severe CU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
- Patients must exhibit spontaneous urticaria lesions in the randomization visit.
- History of beneficial effects of antihistaminic treatment.
- Age between 18 and 60 years.
- Female patients must be using adequate contraceptive precautions (highly effective method), or they must be postmenopausal, surgically sterilised, or hysterectomised (for details please see protocol).
Key exclusion criteria (17 listed)
- The presence of permanent severe diseases, especially those affecting the immune system, except CU.
- The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhea diseases, congenital malformations or surgical mutilations of the 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
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 |
|---|---|---|
| desloratadinesingel dose, oral, 20 mg | Drug | 1 |
| desloratadinesingle dose, oral, 5 mg | Drug | 2 |
Primary outcome
Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by thermography.
Time frame: 5 hours
1 secondary outcome
Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by volumetry and digital time lapse photography.
Time frame: 5 hours
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 31 May 2012.
- Derived from this study: PubMed 23053062Weller K, Ardelean E, Scholz E, Martus P, Zuberbier T, Maurer M. Can on-demand non-sedating antihistamines improve urticaria symptoms? A double-blind, randomized, single-dose study. Acta Derm Venereol. 2013 Mar 27;93(2):168-74. doi: 10.2340/00015555-1434.
- Related InfoLink 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, MD principal investigator
Allergie-Centrum-Charite
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing desloratadine in people with Chronic Urticaria, run by Charite University, Berlin, Germany 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 7 inclusion and 17 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 31 May 2012. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by thermography. (time frame: 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00598611, which also lists 1 linked publication.
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 31 May 2012.