A Prospective Non-comparative Real-World Observational effectiveness and tolerability Study of Hydroxyzine Hydrochloride 50mg Sustain Release formulation for the management of Chronic Pruritus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Change in the NRS itch score in chronic pruritus subjects on Hydroxyzine HCl 50 mg SR tablets from screening visit (baseline) to follow-up visits at week 1 and week 4.
研究概览
简要总结
Hydroxyzine, a first-generation antihistamine, is approved for managing chronic pruritus. However, achieving clinically significant improvement often necessitates higher doses, which can lead to increased peak plasma concentrations (Cmax) and subsequent side effects. To address this concern, a sustainedrelease Hydroxyzine Hydrochloride formulation (Atarax SR tablets) was developed to mitigate Cmax elevation while ensuring sufficient systemic exposure. Despite its extensive use for chronic pruritus management, there’s a notable dearth of comprehensive data on hydroxyzine hydrochloride’s effectiveness in improving PROs, especially in the Indian context. Therefore, this study aims to assess the effectiveness and tolerability of Hydroxyzine HCl 50 mg sustained release formulation as an anti-pruritic, by gathering data from Indian subjects on the medication Hydroxyzine HCl 50 mg SR tablets for the treatment of chronic pruritus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnosed with chronic pruritus (pruritus of more then 6 weeks) Patients who are prescribed with Hydroxyzine and plan for up dosing to Hydroxyzine HCl 50 mg SR tablets or patients who require Hydroxyzine HCl 50 mg SR tablets (higher dose) or newly prescribed to Hydroxyzine HCl 50 mg SR tablets and Non responders to topical and SGA (second-generation antihistamine) therapy Patients with Numerical rating scale itch score of 7 to 10 (inclusive).
排除标准
- •Mild and moderate pruritus due to a primary dermatologic or all other causes other than dermatological causes like systemic psychogenic and neuropathic Patients on systemic immunomodulatory agents and anti depressant Those receiving any centrally acting medication or those with known neurological conditions will be excluded from the study Patients with a known history of cardiovascular disorder.
结局指标
主要结局
Change in the NRS itch score in chronic pruritus subjects on Hydroxyzine HCl 50 mg SR tablets from screening visit (baseline) to follow-up visits at week 1 and week 4.
时间窗: Week 1 week 4
Change in DLQI measured in chronic pruritus subjects on
时间窗: Week 1 week 4
Hydroxyzine HCl 50 mg SR tablets from screening visit (baseline) to follow-up visits at week 1 and week 4
时间窗: Week 1 week 4
次要结局
- Frequency and severity of adverse events (AEs) and serious(adverse events (SAEs) in terms of symptoms, signs, and)
研究者
Dr Sagar Katare
Dr Reddys Laboratories Limited