Aprepitant Versus Hydroxyzine in Persistent Aquagenic Pruritus for Patients With Myeloproliferative Neoplasms

Last updated: June 10, 2021
Sponsor: University Hospital, Brest
Overall Status: Active - Recruiting

Phase

3

Condition

Hives (Urticaria)

Rash

Thrombosis

Treatment

N/A

Clinical Study ID

NCT03808805
ApHyPAP 29BRC18.0036
  • Ages > 18
  • All Genders

Study Summary

Phase 3, randomized prospective study, double blind-double placebo, testing oral therapies APREPITANT versus HYDROXYZINE in patients followed for myeloproliferative neoplasms and suffering of persistent aquagenic pruritus.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Major patients with myeloproliferative neoplasms (polycythemia vera, essentialthrombocythaemia or myelofibrosis)
  • and treated with hydroxyurea, pipobroman, anagrelide, α2a pegylated interferon,ruxolitinib or bled for more than 6 months
  • and suffering of persistent aquagenic pruritus
  • and with a pruritus intensity on Analogic Visual Scale >5/10
  • patients who gave their written consent for participation in the study

Exclusion

Exclusion Criteria:

  • patients with a physical or psychological disability to sign the consent form
  • patients with myeloproliferative neoplasms and suffering of aquagenic pruritus butonly treated by aspirin
  • patients already included in another therapeutic protocol
  • patients with diffuse dermatological disease where pruritus may be present (psoriasis,atopic dermatitis, prurigo
  • patients already on anti-anxiety and / or anti-depressant treatment
  • patients with absolute contraindications to the use of Aprepitant or Hydroxyzine
  • hypersensitivity to Aprepitant and / or Hydroxyzine or to any of their excipients
  • lactose intolerance
  • pregnant or lactating women

Study Design

Total Participants: 80
Study Start date:
April 16, 2019
Estimated Completion Date:
January 01, 2022

Study Description

Identification of patients with myeloproliferative neoplasms and aquagenic pruritus. Evaluation of the intensity of the aquagenic pruritus. Patients with value >5/10 on the VAS (Visual Analogue Scale ) are proposed to participate to the protocole. Randomization between the two treatments. Duration of the treatment : 14 days. Regular evaluation of efficacity of the drugs (questionnaires). Evaluations will stop 2 months after the last intake. Blood samples will be collected before and after the intakes to study cytokine and neuropeptide levels.

Connect with a study center

  • CHRU de Brest - Hôpital Morvan

    Brest, Brest Cedex 29609
    France

    Active - Recruiting

  • CHU d'Angers

    Angers, 49933
    France

    Active - Recruiting

  • CHU de Caen

    Caen, 14033
    France

    Active - Recruiting

  • Centre Hospitalier de Douarnenez

    Douarnenez, 29171
    France

    Site Not Available

  • CHU Grenoble Alpes

    Grenoble, 38043
    France

    Active - Recruiting

  • Centre Léon Bérard

    Lyon, 69373
    France

    Active - Recruiting

  • Centre Hospitalier des Pays de Morlaix

    Morlaix, 29672
    France

    Site Not Available

  • CHU de Nantes

    Nantes, 44093
    France

    Active - Recruiting

  • Centre Hospitalier de Cornouaille

    Quimper, 29107
    France

    Active - Recruiting

  • Hôpital Pontchaillou

    Rennes,
    France

    Active - Recruiting

  • Hôpital Yves Le Foll

    Saint-Brieuc, 22027
    France

    Site Not Available

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