Chronic UrticariaUCT-VNCT01614834
Validation of an Urticaria Control Test
An observational study of Chronic Urticaria, run by Charite University, Berlin, Germany at 2 sites in Germany.
Trial summary
The aim of this study is to validate a previously developed patient reported outcome instrument (in project UCT-D) to assess disease control in chronic urticaria patients (Urticaria Control Test - UCT) of age 12 and older. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Chronic Urticaria
- How many people
- 120 participants
- Where
- 2 sitesGermany
- Study dates
- Jul 2012to Sep 2013
- Phase
- Observational
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: all patients suffering from chronic forms of urticaria
all patients suffering from chronic forms of urticaria are eligible
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Allergie-Centrum-Charite
Berlin, State of Berlin, 10117
Universitätshautklinik Mainz
Mainz, Rhineland-Palatinate, 55131
About this study
Official title: Development (and Validation) of an Instrument to Assess Disease Control in Patients With Urticaria (Urticaria Control Test)
The aim of this study is to validate a previously developed patient reported outcome instrument (in project UCT-D) to assess disease control in chronic urticaria patients (Urticaria Control Test - UCT) of age 12 and older.
- Conditions
- Chronic Urticaria
- Keywords
- urticaria, disease control, severity, test
- 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.
| Study group | Role | What they receive |
|---|---|---|
| chronic urticaria patients | all patients suffering from chronic forms of urticaria (chronic spontaneous urticaria as well as chronic inducible forms such as cold contact urticaria) |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startJul 2012
- Primary completionAug 2013
- Study completionSep 2013
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.
- 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, K. Weller, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614834
- Sponsor's protocol ID
- UCT-V
- Acronym
- UCT-V
- Status last verified
- Jan 2017
- First submitted
- 6 Jun 2012
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development (and Validation) of an Instrument to Assess Disease Control in Patients With Urticaria (Urticaria Control Test)
- ClinicalTrials.gov ID
- NCT01614834
- Acronym / sponsor ID
- UCT-V / UCT-V
- Conditions
- Chronic Urticaria
- Keywords
- urticaria, disease control, severity, test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 8 Jun 2012 (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 validate a previously developed patient reported outcome instrument (in project UCT-D) to assess disease control in chronic urticaria patients (Urticaria Control Test - UCT) of age 12 and older.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| chronic urticaria patients | – | –all patients suffering from chronic forms of urticaria (chronic spontaneous urticaria as well as chronic inducible forms such as cold contact urticaria) |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- all patients suffering from chronic forms of urticaria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 6 Jan 2017.
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A Study to Learn About Ritlecitinib for the Potential Treatment of Chronic Spontaneous Urticaria in Adults.
Chronic Spontaneous Urticaria
Active, not recruitingPhase 3
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Chronic Inducible Urticaria
Active, not recruitingPhase 3
24 Weeks Double-blind Randomized Placebo-controlled Trial to Evaluate Efficacy, PK, Safety of LOU064 in Adolescents (12 - <18) With CSU and Inadequate Response to H1-antihistamine Followed by Optional 3 Years Open-label Extension and an Optional 3 Years Safety Long-term Treatment-free Follow-up
Chronic Spontaneous Urticaria
Not yet recruitingPhase 2
A Trial to Evaluate the Efficacy and Safety of AK139 in Participants With Chronic Spontaneous Urticaria
Chronic Spontaneous Urticaria
Active, not recruitingPhase 3
Phase 3b Study to Assess the Efficacy, Safety, and Tolerability of Remibrutinib in Comparison to Placebo, With Omalizumab as Active Control, in Adult CSU Patients, Followed by an Open-label 52-week Optional Extension.
Chronic Spontaneous Urticaria
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Urticaria, run by Charite University, Berlin, Germany at 2 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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.
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 6 Jan 2017.