NCT01481909: SMART

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

Completed Phase 2/Phase 3 Last updated 2 November 2016

What this trial tests

Phase 2/Phase 3 trial testing Rupatadin in Mastocytosis in 30 participants. Completed in 1 November 2011.

Timeline

1 September 2010

Primary endpoint
1 August 2011

1 November 2011

Quick facts

Lead sponsor	Marcus Maurer
Phase	Phase 2/Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	quadruple
Primary purpose	treatment
Enrollment	30
Start date	1 September 2010
Primary completion	1 August 2011
Estimated completion	1 November 2011
Sites	1 location across Germany

Drugs / interventions tested

• Rupatadin — full drug profile →

Conditions studied

• Mastocytosis — all drugs for Mastocytosis →

Sponsor

Marcus Maurer — full company profile →

Who can join

Adults 18 to 65, any sex, with Mastocytosis. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• 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.

Sponsor's own description

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 involvement

Main criteria for inclusion:

Mastocytosis patients aged 18-65 years, signed written consent, no systemic corticosteroid or other immunosuppressive therapy, no permanent severe diseases Test product, dose and mode of administration 20 mg Rupatadine or placebo before provocation testing, oral administration (tablets)

Duration of treatment:

28 days (testing will be done at the day of last treatment)

Assessment of efficacy:

1. Assessment of wheal and flare development by planimetric analyses of digital photographic, volumetric, and thermographic imaging (time lapse) before and after treatment with study medication,
2. Additional assessment of symptoms,
3. Assessment of life quality

Main criteria of evaluation:

Efficacy

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.