Status:
COMPLETED
Aprepitant Versus Hydroxyzine in Persistent Aquagenic Pruritus for Patients With Myeloproliferative Neoplasms
Lead Sponsor:
University Hospital, Brest
Conditions:
Myeloproliferative Disorder
Aquagenic Pruritus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 persiste...
Detailed 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...
Eligibility Criteria
Inclusion
- Major patients with myeloproliferative neoplasms (polycythemia vera, essential thrombocythaemia 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
- patients with a physical or psychological disability to sign the consent form
- patients with myeloproliferative neoplasms and suffering of aquagenic pruritus but only 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
Key Trial Info
Start Date :
April 16 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 22 2024
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT03808805
Start Date
April 16 2019
End Date
August 22 2024
Last Update
December 3 2025
Active Locations (11)
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1
CHRU de Brest - Hôpital Morvan
Brest, Brest Cedex, France, 29609
2
Centre Hospitalier de Cornouaille
Quimper, Quimper, France, 29107
3
CHU d'Angers
Angers, France, 49933
4
CHU de Caen
Caen, France, 14033