Trial intelligence / Profile preview

SMART: Rupatadine for Mastocytosis Symptoms

NCT01481909Phase 3

Key facts

Status: Completed
Start: Sep 2010
Primary completion: Aug 2011
Countries: 1
Modality: Small Molecules

Drugs: rupatadine
Conditions: mastocytosis

Overview

Phase 3, randomised, double-blind trial of rupatadine in mastocytosis (2 arms). Primary endpoint: Reduction of wheal and flare type skin reaction at 28 days. Started Sep 2010; status: completed.

Design

2 arms

Study design: RandomizedDouble-blind

Rupatadine -> Placebo
Patients receive Rupatadine in Period 1 and Placebo in Period 2
Placebo -> Rupatadine
Patients receive Placebo in Period 1 and Rupatadine in Period 2

Who it enrols

Adult patients (18-65 years) with chronic stable symptomatic maculopapulous cutaneous mastocytosis or indolent systemic mastocytosis with skin involvement and a positive Darier's Sign. Patients must not have severe permanent diseases, active cancer, or severe renal/hepatic dysfunction.

Endpoints

Primary

Reduction of wheal and flare type skin reaction28 days

Secondary

Pruritus Symptom Score28 days
Dermatology Life Quality Index28 days
Itchy Quality of Life28 days
Visual Analogue Scale28 days

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