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

NCT01605487 | Completed Phase 2

• 1 other identifier: PAFCUTIII
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Cold Contact Urticaria

Outcome Measures

Primary Outcomes (2)

• 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

  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)

• Critical temperature threshold (CTT)after challenge with cold

  Critical temperature threshold (CTT) determines the highest temperature sufficient for inducing a wheal-and-flare reaction

  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 Outcomes (2)

• Mast cell mediator release

  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)

• Safety and tolerability following administration of Rupatadine to patients with cold contact urticaria

  up to 9 weeks

Study Arms (6)

Rupatadine 20mg - Placebo - Rupatadine 40mg

OTHER

Drug: Rupatadine

Rupatadine 20mg - Rupatadine 40mg - Placebo

OTHER

Drug: Rupatadine

Placebo - Rupatadine 20mg - Rupatadine 40mg

OTHER

Drug: Rupatadine

Rupatadine 40mg - Placebo - Rupatadine 20mg

OTHER

Drug: Rupatadine

Placebo - Rupatadine 40mg - Rupatadine 20mg

OTHER

Drug: Rupatadine

Rupatadine 40mg - Rupatadine 20mg - Placebo

OTHER

Drug: Rupatadine

Interventions

Rupatadine DRUG

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

Rupatadine 20mg - Placebo - Rupatadine 40mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Hospital del Mar: collaborator

Study Sites (1)

Department of Dermatology and Allergy

Charité - Universitätsmedizin Berlin, Charitéplatz 1, 10117 Berlin, Germany

Location

MeSH Terms

Conditions

Cold Urticaria

Interventions

rupatadine

Condition Hierarchy (Ancestors)

Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Karoline Krause, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 11, 2012
• First Posted: May 25, 2012
• Study Start: June 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2014
• Last Updated: October 15, 2014

Record last verified: 2014-04

Locations

DE (1)