NCT00598611

Brief 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. Hypothesis: Updosing of desloratadine (20mg) is more efficient in the treatment of urticarial lesions as compared to standard dosing (5 mg desloratadine).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2007

Geographic Reach
1 country

1 active site

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

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 22, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

May 31, 2012

Status Verified

May 1, 2012

Enrollment Period

1.9 years

First QC Date

January 10, 2008

Last Update Submit

May 30, 2012

Conditions

Chronic Urticaria

Keywords

urticaria

Outcome Measures

Primary Outcomes (1)

  • Reduction in size of existing spontaneous urticaria lesions (wheal and flare) as assessed by thermography.

    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.

    5 hours

Study Arms (2)

1

ACTIVE COMPARATOR

desloratadine 20 mg

Drug: desloratadine

2

ACTIVE COMPARATOR

desloratadine 20 mg

Drug: desloratadine

Interventions

desloratadineDRUG

singel dose, oral, 20 mg

1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).
  • 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.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Allergie-Centrum-Charite

Berlin, State of Berlin, 10117, Germany

Location

Related Publications (1)

  • 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.

    PMID: 23053062DERIVED

Related Links

MeSH Terms

Conditions

Chronic UrticariaUrticaria

Interventions

desloratadine

Condition Hierarchy (Ancestors)

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

Study Officials

  • Marcus Maurer, MD

    Allergie-Centrum-Charite

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Karsten Weller

Study Record Dates

First Submitted

January 10, 2008

First Posted

January 22, 2008

Study Start

September 1, 2007

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

May 31, 2012

Record last verified: 2012-05

Locations

DE(1)