A Study to Assess and Compare the Effects of 5 mg vs. 20... | NCT00600847

Studies
A Study to Assess and Compare the Effects of 5 mg vs. 20 mg Desloratadine on the Development of Cold Urticaria Lesions

NCT00600847

Sponsor

Charite University, Berlin, Germany

Status

Completed

Last Update Posted

Jan 25, 2008Estimated

Enrollment

33Actual

Phase

Phase 4

Conditions

Acquired Cold Urticaria

Interventions

desloratadine
desloratadine
placebo

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
EudraCT-Number: 2005-006133-32

Status Module

Record Verification Date

Jan 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2006

Primary Completion Date

Nov 2007Actual

Completion Date

Not provided

First Submitted Date

Jan 15, 2008

First Submission Date that Met QC Criteria

Jan 15, 2008

First Posted Date

Jan 25, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 15, 2008

Last Update Posted Date

Jan 25, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

33Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	desloratadine 20 mg	Drug: desloratadine
2	Active Comparator	desloratadine 5 mg	Drug: desloratadine
3	Placebo Comparator		Drug: placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
desloratadine	Drug	single dose for 7 days, oral, 20mg	1
desloratadine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Reduction in the development of urticaria lesions (wheal and flare) induced by TempTest challenge as assessed by digital time lapse photography, volumetry and thermography.		90 minutes

Secondary Outcomes

Measure	Description	Time Frame
Decrease in critical temperature thresholds and increase in critical stimulation time thresholds as assessed by standardized TempTest challenge.		15 minutes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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)
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D017445	Skin Diseases, Vascular
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D006969	Hypersensitivity, Immediate

ID	Term
D014581	Urticaria
D000096703	Cold Urticaria