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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hospital del Mar
Information provided by (Responsible Party):
Marina Abajian, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01605487
First received: May 11, 2012
Last updated: April 22, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Cold Contact Urticaria
Drug: Rupatadine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Critical stimulation time threshold(CSTT) after challenge with cold [ 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) ] [ Designated as safety issue: No ]
    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 [ 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) ] [ Designated as safety issue: No ]
    Critical temperature threshold (CTT) determines the highest temperature sufficient for inducing a wheal-and-flare reaction


Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
  • Safety and tolerability following administration of Rupatadine to patients with cold contact urticaria [ Time Frame: up to 9 weeks ] [ Designated as safety issue: Yes ]
    Safety and tolerability: This includes physical examination, routine safety laboratory assessments, clinical observation, vital sings and adverse event reporting


Enrollment: 24
Study Start Date: June 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Rupatadine 20mg - Placebo - Rupatadine 40mg Drug: Rupatadine
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 - Rupatadine 40mg - Placebo Drug: Rupatadine
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
Placebo - Rupatadine 20mg - Rupatadine 40mg Drug: Rupatadine
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
Rupatadine 40mg - Placebo - Rupatadine 20mg Drug: Rupatadine
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
Placebo - Rupatadine 40mg - Rupatadine 20mg Drug: Rupatadine
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
Rupatadine 40mg - Rupatadine 20mg - Placebo Drug: Rupatadine
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01605487

Locations
Germany
Department of Dermatology and Allergy
Charité - Universitätsmedizin Berlin, Charitéplatz 1, Germany, 10117 Berlin
Sponsors and Collaborators
Charite University, Berlin, Germany
Hospital del Mar
Investigators
Principal Investigator: Karoline Krause, MD Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Marina Abajian, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01605487     History of Changes
Other Study ID Numbers: PAFCUTIII
Study First Received: May 11, 2012
Last Updated: April 22, 2014
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Cyproheptadine
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Serotonin Antagonists
Serotonin Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on September 30, 2014