Aprepitant Versus Hydroxyzine in Association With Cytoreductive Treatments for Patients With Myeloproliferative Neoplasia Suffering From Persistent Aquagenic Pruritus.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 11
- 主要终点
- Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
studied group
Aprepitant 80 mg daily - 14 days Plus placebo of Hydroxyzine - 14 days
干预措施: Aprepitant 80 mg (Drug)
studied group
Aprepitant 80 mg daily - 14 days Plus placebo of Hydroxyzine - 14 days
干预措施: Placebo of Hydroxyzine (Drug)
comparative group
Hydroxyzine 25 mg/d - 14 days Plus placebo of Aprepitant - 14 days
干预措施: Hydroxyzine 25mg (Drug)
comparative group
Hydroxyzine 25 mg/d - 14 days Plus placebo of Aprepitant - 14 days
干预措施: Placebo of Aprepitant (Drug)
结局指标
主要结局
Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )
时间窗: at 15 days
number of patients with a pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale wich measure the intensity of symptoms of pruritus, 0 is minimum and 10 is maximum intensity of symptoms)
次要结局
- Time observed to decreased the VAS to 3/10(01 to 60 days)
- Reduction of pruritus intensity below (or equal) 3/10 on the VAS (Visual Analogue Scale )(at 60 days)
- Cessation of pruritus(at 60 days)
- Duration of treatment effectiveness(1 to 60 days)
- Quality of life through the use of validated questionnaire : the PASYMPLE questionnaire(at 60 days)
- Quality of life through the use of validated questionnaires : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire(at 30 days)
- Adverse event occurring during the association therapeutic(at 15 days)
- Complete blood count (normal or abnormal)(1 to 60 days)
- Number of prematurely discontinued anti-pruritic treatment(at 15 days)
- Quality of life through the use of validated questionnaire : the MPN-SAF (Myeloproliferative Neoplasm Symptom Assessment Form) questionnaire(at 60 days)
- Quantification of the change of plasma concentrations of cytokines and neuropeptides(at 60 days)