A Multi-Centric, Prospective, Single Arm, Open label Post Marketing Observational Study To Assess The Effectiveness And Safety Of Oral Prochlorperazine In Acute Phase In Patients Diagnosed With Benign Paroxysmal Positional Vertigo (BPPV).
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- To evaluate the effectiveness of prochlorperazine 5mg Tablet in the acute phase in patients diagnosed with BPPV.
研究概览
简要总结
This is a prospective, multicenter, single-arm, open-label, post-marketing observational study designed to evaluate the effectiveness and safety of prochlorperazine 5mg tablet in the management of BPPV in patients in the age group of ≥18 to ≤65 years. This multicenter study will enroll approximately 300 adult patients with BPPV. The patients will be followed up for 3-days after enrollment into the study. The enrollment of patients for the study will be based on the approved protocol by the local ethics committee. All the patients with a clinical diagnosis of BPPV, meeting all inclusion and none of the exclusion criteria, and ready to give informed consent for study participation, are eligible for participation in this observational study. The study is planned to be conducted for approximately 8 months.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and female patients in the age group of ≥18 to ≤65 years, with confirmed diagnosis of BPPV and prescribed prochlorperazine for acute phase by treating physician as per approved label.
- •The patient who has read the informed consent form and has understood the relevant aspects of the clinical study and grants his/her authorization to participate by signing the informed consent form before the inclusion in the clinical study and the performance of any procedure.
排除标准
- •Patients on prochlorperazine or any other anti-vertigo therapy drugs in the past 15 days.
- •Patients with a history of psychiatric illness or on anti-psychotic or anti-depressant medication in the past 6 months.
- •Patients with a history of cardiovascular, kidney, or liver disorders.
- •Patients with suspected or established subcortical brain damage, with or without hypothalamic damage.
- •Females who are pregnant/planning to become pregnant/not ready to use contraceptive measures or are lactating.
- •Patients with a known history of hypersensitivity to phenothiazine derivatives.
- •Patients with a history of any malignancy.
- •Patients who are unsuitable for any other reason to participate in the study in the opinion of the investigator or those requiring hospitalization for any cause.
- •Patients who are on concomitant medications such as anticholinergics, barbiturates, beta-blockers, cisapride, sparfloxacin, guanethidine, Metrizamide, Paroxetine, antihypertensives.
结局指标
主要结局
To evaluate the effectiveness of prochlorperazine 5mg Tablet in the acute phase in patients diagnosed with BPPV.
时间窗: Day 1 and 4
次要结局
- Effectiveness 1. To assess improvement in the severity of vertigo-associated symptoms (Anxiety, Headache, and Nausea/ Vomiting) post-treatment with prochlorperazine 5mg tablet Safety 1. To evaluate the safety and tolerability of treatment with prochlorperazine 5mg tablet in the Indian adult population with BPPV.(Day 1 and 4)
研究者
Dr Sudipta Chandra
PURNAM MEDICARE