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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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<

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.


Detailed Summary:
Sponsor: Charite University, Berlin, Germany

Current Primary Outcome:

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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) ]
  • Safety and tolerability following administration of Rupatadine to patients with cold contact urticaria [ Time Frame: up to 9 weeks ]
    Safety and tolerability: This includes physical examination, routine safety laboratory assessments, clinical observation, vital sings and adverse event reporting


Original Secondary Outcome: Same as current

Information By: Charite University, Berlin, Germany

Dates:
Date Received: May 11, 2012
Date Started: June 2012
Date Completion:
Last Updated: October 14, 2014
Last Verified: April 2014