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Aprepitant in the Management of Biological Therapies-related Severe Pruritus

NCT01683552 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2012-09-12

No results posted yet for this study

Summary

Itch is a common side effect of anti-epidermal growth factor receptor antibodies and tyrosine kinase inhibitors. Investigators designed a pilot single-center phase II study evaluating the effects of Aprepitant, a neurokinin receptor inhibitor, in managing biological therapy-induced pruritus.

Conditions

  • ITCH

Interventions

DRUG

Aprepitant

125 mg on day 1; 80 mg on day 3; 80 mg on day 5

DRUG

Prednisone

In the refractory group (VAS score ≥7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die),

DRUG

Fexofenadine

In the refractory group (VAS score ≥7), Aprepitant (125 mg on day 1; 80 mg on day 3; 80 mg on day 5) is administered after at least one week of standard systemic treatment (prednisone 25 mg/die and/or fexofenadine 180 mg/die)

Sponsors & Collaborators

  • Campus Bio-Medico University

    lead OTHER

Principal Investigators

  • Daniele Santini, MD, PhD · Campus Bio-Medico of Rome University

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-09-30
Primary Completion
2011-11-30
Completion
2011-11-30

Countries

  • Italy

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01683552 on ClinicalTrials.gov