Acquired Cold UrticariaPhase 4AUDACUNCT00600847
A Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Cold Urticaria Lesions
A Phase 4 study testing desloratadine in people with Acquired Cold Urticaria, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim of this study is to compare cold urticaria lesions by thermography, volumetry and digital time lapse photography in ACU patients treated with placebo, 5 mg and 20 mg desloratadine. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acquired Cold Urticaria
- What is being tested?
- desloratadine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2006to Nov 2007
- 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
- Outpatients with ACU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
- History of beneficial effects of antihistaminic treatment.
- Age between 18 and 75 years.
- Female patients must be using a highly effective method of birth control (such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence,vasectomised partner), 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 ACU
- 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
- Evidence of significant hepatic disease (liver enzymes twice the upper reference value)
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- History of adverse reactions to DL, loratadine, or other ingredients of the IMP
- Presence of active cancer which requires chemotherapy or radiation therapy
- Presence of acute urticaria, angioedema, or larynx edema
- History or presence of alcohol abuse or drug addiction
- Participation in any clinical trial within 4 weeks prior to enrolment
- Commitment to an institution in terms of § 40 Abs. 1 Nr. 4 AMG
- Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study
- Intake of oral corticosteroids 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Exploratory Phase IV, Randomised, Double-Blind, Placebo Controlled Crossover Study to Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Experimentally Induced Urticaria Lesions
The aim of this study is to compare cold urticaria lesions by thermography, volumetry and digital time lapse photography in ACU patients treated with placebo, 5 mg and 20 mg desloratadine. Hypothesis: The updosing of desloratadine (20 mg)is more effective in the treatment of ACU symptoms as compared to standard doses (5 mg desloratadine) and placebo.
- Conditions
- Acquired Cold Urticaria
- Being tested
- desloratadine, placebo
- Keywords
- urticaria, cold urticaria, acquired cold urticaria
- Medical subject headings
- Urticaria, Cold Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
desloratadineDrug
single dose for 7 days, oral, 20mg
desloratadineDrug
single dose for 7 days, oral, 5 mg
placeboDrug
single dose for 7 days, oral
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | desloratadine 20 mg Receives: Drug: desloratadine |
| 2 | Active comparator | desloratadine 5 mg Receives: Drug: desloratadine |
| 3 | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the development of urticaria lesions (wheal and flare) induced by TempTest challenge as assessed by digital time lapse photography, volumetry and thermography.
Measured: 90 minutes
Secondary outcomes (1)
Decrease in critical temperature thresholds and increase in critical stimulation time thresholds as assessed by standardized TempTest challenge.
Measured: 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startNov 2006
- Primary completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Cold 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Marcus Maurer, MD, Principal investigator, Allergie-Centrum-Charité
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00600847
- Sponsor's protocol ID
- P04685
- Other IDs
- EudraCT-Number: 2005-006133-32
- Acronym
- AUDACU
- Status last verified
- Jan 2008
- First submitted
- 15 Jan 2008
- Last updated
- 25 Jan 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Phase IV, Randomised, Double-Blind, Placebo Controlled Crossover Study to Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Experimentally Induced Urticaria Lesions
- ClinicalTrials.gov ID
- NCT00600847
- Acronym / sponsor ID
- AUDACU / P04685
- Conditions
- Acquired Cold Urticaria
- Keywords
- urticaria, cold urticaria, acquired cold urticaria
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Nov 2007 (actual)
- First posted
- 25 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 aim of this study is to compare cold urticaria lesions by thermography, volumetry and digital time lapse photography in ACU patients treated with placebo, 5 mg and 20 mg desloratadine. Hypothesis: The updosing of desloratadine (20 mg)is more effective in the treatment of ACU symptoms as compared to standard doses (5 mg desloratadine) and placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: desloratadinedesloratadine 20 mg |
| 2 | Active comparator | Drug: desloratadinedesloratadine 5 mg |
| 3 | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Outpatients with ACU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
- History of beneficial effects of antihistaminic treatment.
- Age between 18 and 75 years.
- Female patients must be using a highly effective method of birth control (such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence,vasectomised partner), or they must be postmenopausal, surgically sterilised, or hysterectomised.
- Voluntarily signed written informed consent.
Key exclusion criteria (16 listed)
- The presence of permanent severe diseases, especially those affecting the immune system, except ACU
- 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
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 |
|---|---|---|
| desloratadinesingle dose for 7 days, oral, 20mg | Drug | 1 |
| desloratadinesingle dose for 7 days, oral, 5 mg | Drug | 2 |
| placebosingle dose for 7 days, oral | Drug | 3 |
Primary outcome
Reduction in the development of urticaria lesions (wheal and flare) induced by TempTest challenge as assessed by digital time lapse photography, volumetry and thermography.
Time frame: 90 minutes
1 secondary outcome
Decrease in critical temperature thresholds and increase in critical stimulation time thresholds as assessed by standardized TempTest challenge.
Time frame: 15 minutes
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 25 Jan 2008.
- Related InfoLink provided by the sponsor.
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-Charité
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 Acquired Cold 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 5 inclusion and 16 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 25 Jan 2008. 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. Some participants in this study may receive a placebo. 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?
Reduction in the development of urticaria lesions (wheal and flare) induced by TempTest challenge as assessed by digital time lapse photography, volumetry and thermography. (time frame: 90 minutes). 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 25 Jan 2008.