Clinical Trial: Study on Mastocytosis for Rupatadine Treatment

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

Official Title: Study on Mastocytosis for Rupatadine Treatment An Exploratory Phase IV, Randomised, Double-blind, Placebo Controlled Crossover Study to Assess the Efficacy of 20 mg Rupata

Brief Summary:

Study title:

An exploratory, randomised, double-blind, placebo controlled crossover study to assess the efficacy of 20 mg Rupatadine on the treatment of mastocytosis symptoms.

Study code:

SMART-2010-1 Principal Investigator, Co-Investigator, sponsor, and study centre (acc. to § 40 Abs. 4 AMG) Dr. med. F. Siebenhaar, Prof. Dr. Med. M. Maurer, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin Biometry and biostatistical analyses Division of Biostatistics and Clinical Epidemiology, Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin Monitoring Coordination Centre for Clinical Studies (KKS), Charité - Universitätsmedizin Berlin, Charitéplatz 1, D-10117 Berlin Clinical phase Phase II

Primary objective:

Reduction of wheal and flare type skin reaction after standardised provocation testing assessed by volumetric and thermographic measurements.

Secondary objectives:

Improvement of additional related symptoms (e.g. pruritus) and subjective affliction as assessed by symptom score, DLQI, Itchy-QoL and VAS.

Study design:

An exploratory, randomised, double-blind, placebo controlled crossover study

Type and number of patients:

Male and female patients (n = 30) with cutaneous mastocytosis and indolent systemic mastocytosis with skin involvemen

Detailed Summary:
Sponsor: Marcus Maurer

Current Primary Outcome: Pruritus [ Time Frame: 10 weeks ]

Reduction of pruritus and wheal and flare type skin reaction after standardised provocation testing as assessed by volumetric and thermographic measurements.


Original Primary Outcome: Same as current

Current Secondary Outcome: Questionaire [ Time Frame: 10 weeks ]

Improvement of additional disease related symptoms and subjective affliction as measured by physician and patient global assessments, DLQI, Itchy-QoL and QoL(i)MaP*.

*not validated questionnaire for mastocytosis symptoms



Original Secondary Outcome: Same as current

Information By: Charite University, Berlin, Germany

Dates:
Date Received: November 23, 2011
Date Started: September 2010
Date Completion:
Last Updated: November 2, 2016
Last Verified: November 2016