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

Regional University Hospital Center (CHRU)

Status and phase: Completed; Phase 3

Conditions: Aquagenic Pruritus; Myeloproliferative Disorder

Treatments: Drug: Hydroxyzine 25mg; Drug: Placebo of Hydroxyzine; Drug: Placebo of Aprepitant; Drug: Aprepitant 80 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT03808805

2018-000426-66 (EudraCT Number)

ApHyPAP 29BRC18.0036

Details and patient eligibility

About

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.

Full 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.

Enrollment: 63 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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63 participants in 2 patient groups

studied group

Experimental group

Description:

Aprepitant 80 mg daily - 14 days Plus placebo of Hydroxyzine - 14 days

Treatment:

Drug: Aprepitant 80 mg

Drug: Placebo of Hydroxyzine

comparative group

Active Comparator group

Description:

Hydroxyzine 25 mg/d - 14 days Plus placebo of Aprepitant - 14 days

Treatment:

Drug: Placebo of Aprepitant

Drug: Hydroxyzine 25mg