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Study to Assess Efficacy, Safety and Mechanism of Rupatadine in Cold Urticaria (PAFCUTIII)

Primary Purpose

Cold Contact Urticaria

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Rupatadine
Rupatadine
Rupatadine
Rupatadine
Rupatadine
Rupatadine
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cold Contact Urticaria

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Informed consent signed and dated
  • Reliable method of contraception for both women of childbearing potential as well as man during the study and 3 months thereafter. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner
  • Outpatients with CCU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch after contact cooling of the skin. Provocation should be performed by application of Temptest®3.0 which allows for reproducible and standardized cold provocation tests and the identification of temperature and stimulation time thresholds.
  • Age 18 and above 18 years.
  • No participation in other clinical trials 1 months before and after participation in this study

Exclusion Criteria:

  • Subjects who are inmates of psychiatric wards, prisons, or other state institutions. Existing or planned placement in an institution after ruling according to § 40 passage 1, number 4 AMG (Arzneimittelgesetz).
  • The presence of permanent severe diseases, especially those affecting the immune system, except urticaria and cold urticaria
  • 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
  • ECG alterations of repolarisation (QTc prolongations > 450ms)
  • Blood pressure >180/100 mmHg and/or heart rate >100/min.
  • Evidence of significant hepatic or renal disease (GOT and/or GPT 3 times above the upper reference value, serum creatinine 1.5 times above the upper reference value)
  • History of hypersensitivity or allergic reaction to rupatadine or its ingredients or any other antihistamine compounds.
  • Presence of active cancer which requires chemotherapy or radiation therapy
  • Presence of lactose and galactose intolerance or with glucose-galactose malabsorption
  • Simultaneous chronic spontaneous or physical urticaria that could interfere CCU clinical assessment
  • Intake of antihistamines or antileukotrienes within 7 days before beginning of the study
  • Intake of oral or depot corticosteroids within 14 days prior to screening visit
  • Use of systemic immunosupressants/immunomodulators like cyclosporine A, dapsone, methotrexate, mycophenolate, chloroquine, and comparable drugs within 28 days prior to screening visit.
  • Use of ketoconazole, erythromycin or potential inhibitors of the isoenzyme CYP3A4 of the cytochrome P450.
  • Currently abusing drugs or alcohol
  • Unwilling or unable to comply with the protocol
  • Pregnancy or breast-feeding

Sites / Locations

  • Department of Dermatology and Allergy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Other

Other

Other

Other

Other

Other

Arm Label

Rupatadine 20mg - Placebo - Rupatadine 40mg

Rupatadine 20mg - Rupatadine 40mg - Placebo

Placebo - Rupatadine 20mg - Rupatadine 40mg

Rupatadine 40mg - Placebo - Rupatadine 20mg

Placebo - Rupatadine 40mg - Rupatadine 20mg

Rupatadine 40mg - Rupatadine 20mg - Placebo

Arm Description

Outcomes

Primary Outcome Measures

Critical stimulation time threshold(CSTT) after challenge with cold
Critical stimulation time threshold (CSTT) determines the shortest stimulation time sufficient for inducing a wheal-and-flare reaction
Critical temperature threshold (CTT)after challenge with cold
Critical temperature threshold (CTT) determines the highest temperature sufficient for inducing a wheal-and-flare reaction

Secondary Outcome Measures

Mast cell mediator release
Safety and tolerability following administration of Rupatadine to patients with cold contact urticaria
Safety and tolerability: This includes physical examination, routine safety laboratory assessments, clinical observation, vital sings and adverse event reporting

Full Information

First Posted
May 11, 2012
Last Updated
October 14, 2014
Sponsor
Charite University, Berlin, Germany
Collaborators
Hospital del Mar
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1. Study Identification

Unique Protocol Identification Number
NCT01605487
Brief Title
Study to Assess Efficacy, Safety and Mechanism of Rupatadine in Cold Urticaria
Acronym
PAFCUTIII
Official Title
Double-blind, Three-way Cross-over, Placebo-controlled Study to Assess the Efficacy, Safety and Mechanisms of Treatment With Rupatadine 20 mg and 40 mg in Cold Contact Urticaria (CCU)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Hospital del Mar

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Main objective of this study is to evaluate the efficacy of rupatadine in 20 mg and 40 mg doses in the development of symptoms of cold contact urticaria. For this purpose, a Peltier element-based electronic provocation device (TempTest®, emo systems GmbH, Berlin, Germany) will be used. This allows skin exposure to 12 different temperatures from 4 to 42 °C simultaneously in a standardized and reproducible way and thus the determination of individual temperature and/or stimulation time thresholds. In addition mediators related from activated must cells such as histamine, PAF, PGD2 should be identified in the period between the application of stimulus and the appearance of symptoms of cold urticaria and should be characterized qualitatively and quantitatively.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cold Contact Urticaria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rupatadine 20mg - Placebo - Rupatadine 40mg
Arm Type
Other
Arm Title
Rupatadine 20mg - Rupatadine 40mg - Placebo
Arm Type
Other
Arm Title
Placebo - Rupatadine 20mg - Rupatadine 40mg
Arm Type
Other
Arm Title
Rupatadine 40mg - Placebo - Rupatadine 20mg
Arm Type
Other
Arm Title
Placebo - Rupatadine 40mg - Rupatadine 20mg
Arm Type
Other
Arm Title
Rupatadine 40mg - Rupatadine 20mg - Placebo
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Rupatadine
Intervention Description
Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days, then 14 days washout period; Placebo 4 Tab once daily during 7 days, then 14 days washout period; Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days
Intervention Type
Drug
Intervention Name(s)
Rupatadine
Intervention Description
Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days, then 14 days washout period; Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days,then 14 days washout period; Placebo 4 Tab once daily during 7 days
Intervention Type
Drug
Intervention Name(s)
Rupatadine
Intervention Description
Placebo 4 Tab once daily during 7 days, then 14 days washout period; Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days, then 14 days washout period; Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days
Intervention Type
Drug
Intervention Name(s)
Rupatadine
Intervention Description
Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days,then 14 days washout period; Placebo 4 Tab once daily during 7 days, then 14 days washout period; Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days
Intervention Type
Drug
Intervention Name(s)
Rupatadine
Intervention Description
Placebo 4 Tab once daily during 7 days, then 14 days washout period; Rupatadine in Tab. 10mg, 4 Tab. once daily during 7 days, then 14 days washout period; Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days
Intervention Type
Drug
Intervention Name(s)
Rupatadine
Intervention Description
Rupatadine in Tab. 10mg: 4 Tab. once daily during 7 days, then 14 days washout period; Rupatadine in Tab 10mg: 4 Tab.(2 Tab. of Rupatadine + 2 Tab. of Placebo) once daily during 7 days, then 14 days washout period; Placebo 4 Tab once daily during 7 days
Primary Outcome Measure Information:
Title
Critical stimulation time threshold(CSTT) after challenge with cold
Description
Critical stimulation time threshold (CSTT) determines the shortest stimulation time sufficient for inducing a wheal-and-flare reaction
Time Frame
Visit 1(day -14 Screening), Visit 2 (Randomization; day 0), Visit 3(Last day of treatment period 1; day 7), Visit 4(Last day of treatment period 2; day 28), Visit 5(Last day of treatment period 3; day 49)
Title
Critical temperature threshold (CTT)after challenge with cold
Description
Critical temperature threshold (CTT) determines the highest temperature sufficient for inducing a wheal-and-flare reaction
Time Frame
Visit 1(day -14 Screening), Visit 2 (Randomization; day 0), Visit 3(Last day of treatment period 1; day 7), Visit 4(Last day of treatment period 2; day 28), Visit 5(Last day of treatment period 3; day 49)
Secondary Outcome Measure Information:
Title
Mast cell mediator release
Time Frame
Visit 3(Last day of treatment period 1; day 7), Visit 4(Last day of treatment period 2; day 28), Visit 5(Last day of treatment period 3; day 49)
Title
Safety and tolerability following administration of Rupatadine to patients with cold contact urticaria
Description
Safety and tolerability: This includes physical examination, routine safety laboratory assessments, clinical observation, vital sings and adverse event reporting
Time Frame
up to 9 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent signed and dated Reliable method of contraception for both women of childbearing potential as well as man during the study and 3 months thereafter. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner Outpatients with CCU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch after contact cooling of the skin. Provocation should be performed by application of Temptest®3.0 which allows for reproducible and standardized cold provocation tests and the identification of temperature and stimulation time thresholds. Age 18 and above 18 years. No participation in other clinical trials 1 months before and after participation in this study Exclusion Criteria: Subjects who are inmates of psychiatric wards, prisons, or other state institutions. Existing or planned placement in an institution after ruling according to § 40 passage 1, number 4 AMG (Arzneimittelgesetz). The presence of permanent severe diseases, especially those affecting the immune system, except urticaria and cold urticaria 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 ECG alterations of repolarisation (QTc prolongations > 450ms) Blood pressure >180/100 mmHg and/or heart rate >100/min. Evidence of significant hepatic or renal disease (GOT and/or GPT 3 times above the upper reference value, serum creatinine 1.5 times above the upper reference value) History of hypersensitivity or allergic reaction to rupatadine or its ingredients or any other antihistamine compounds. Presence of active cancer which requires chemotherapy or radiation therapy Presence of lactose and galactose intolerance or with glucose-galactose malabsorption Simultaneous chronic spontaneous or physical urticaria that could interfere CCU clinical assessment Intake of antihistamines or antileukotrienes within 7 days before beginning of the study Intake of oral or depot corticosteroids within 14 days prior to screening visit Use of systemic immunosupressants/immunomodulators like cyclosporine A, dapsone, methotrexate, mycophenolate, chloroquine, and comparable drugs within 28 days prior to screening visit. Use of ketoconazole, erythromycin or potential inhibitors of the isoenzyme CYP3A4 of the cytochrome P450. Currently abusing drugs or alcohol Unwilling or unable to comply with the protocol Pregnancy or breast-feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karoline Krause, MD
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology and Allergy
City
Charité - Universitätsmedizin Berlin
State/Province
Charitéplatz 1
ZIP/Postal Code
10117 Berlin
Country
Germany

12. IPD Sharing Statement

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Study to Assess Efficacy, Safety and Mechanism of Rupatadine in Cold Urticaria

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