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Efficacy Study of Omalizumab in Cholinergic Urticaria

NCT02012387 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2019-02-12

No results posted yet for this study

Summary

To demonstrate the efficacy and safety of Omalizumab in a new indication, that is cholinergic urticaria.

Conditions

Interventions

BIOLOGICAL

Active

Two injections will be administered every four weeks for four months, we will administer 4 doses within 16 weeks

BIOLOGICAL

Placebo

Two injections will be administered every four weeks for four months, we will administer 4 doses within 16 weeks

BIOLOGICAL

Open labeled

Two injections will be administered every four weeks for 8 months, we will administer 4 doses within 32 weeks

Sponsors & Collaborators

  • Hospital Clinic of Barcelona

    collaborator OTHER

  • Hospital Universitari Joan XXIII de Tarragona.

    collaborator OTHER

  • Hospital General Universitario Gregorio Marañon

    collaborator OTHER

  • Complejo Hospitalario de Navarra

    collaborator OTHER

  • Hospital Universitario Central de Asturias

    collaborator OTHER

  • Hospital Clínico Universitario Lozano Blesa

    collaborator OTHER

  • Hospital Vall d'Hebron

    collaborator OTHER

  • Clinica Universidad de Navarra, Universidad de Navarra

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-09-30
Completion
2017-06-30

Countries

  • Spain

Study Locations

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Entities

Drugs
Diseases

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 NCT02012387 on ClinicalTrials.gov