NCT01610128

Brief Summary

The aim of the project is to develop a patient reported outcome instrument to assess disease control in chronic urticaria patients (Urticaria Control Test - UCT) of age 12 and older.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
508

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 30, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 1, 2012

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

January 6, 2017

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

May 30, 2012

Last Update Submit

January 5, 2017

Conditions

Chronic Urticaria

Keywords

urticaria, patient reported outcome

Study Arms (1)

chronic urticaria patients

all patients suffering from chronic types of urticaria (chronic spontaneous urticaria as well as chronic inducible forms such as cold contact urticaria)

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

all patients suffering from chronic forms of urticaria

You may qualify if:

  • all patients suffering from chronic forms of urticaria are eligible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Universitätshautklinik Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Allergie-Centrum-Charite

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Chronic UrticariaUrticaria

Condition Hierarchy (Ancestors)

Skin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 30, 2012

First Posted

June 1, 2012

Study Start

October 1, 2011

Primary Completion

June 1, 2013

Study Completion

August 1, 2013

Last Updated

January 6, 2017

Record last verified: 2017-01

Locations

DE(2)