CTRI/2022/01/039287已完成Unknown
A Prospective, Multicenter, Open-Label, Single-Arm, Post Marketing Observational Studyto Assess the Effectiveness and Safety of Prochlorperazine In Patients with Acute Vertigo
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 1,708
- 试验地点
- 28
- 主要终点
- response evaluation (SVVSLCRE), from baseline to post-treatment
研究概览
简要总结
A Prospective, Multicenter, Open-Label, Single-Arm, Post Marketing Observational Study
to Assess the Effectiveness and Safety of Prochlorperazine In Patients with Acute Vertigo
Total 1708 patient will be recruited in the study in India. There will be total 5 Visits.
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
- •Patients of either sex in the age group of 18-65 years.
- •Patients diagnosed with Meniere’s disease, vestibular neuritis, labyrinthitis, or post-operative vertigo.
- •Patients willing to participate in the study and sign an informed consent form.
排除标准
- •Patients diagnosed with BPPV.
- •Patients with history of psychiatric illness.
- •Patients on anti-psychotic or anti-depressant medication.
- •Patients with history of cardiovascular, kidney or liver disorder.
- •Patients requiring hospitalization for any cause.
- •Patients with suspected or established subcortical brain damage, with or without hypothalamic damage.
- •Pregnant and nursing women.
- •Women with childbearing potential who are not practicing a reliable method of birth control.
- •Patients with a known history of hypersensitivity to phenothiazine derivatives.
结局指标
主要结局
response evaluation (SVVSLCRE), from baseline to post-treatment
时间窗: Visit1 to Visit 5
To evaluate the effectiveness of prochlorperazine in acute vertigo patients, by assessing
时间窗: Visit1 to Visit 5
clinical response based on the scale for vestibular vertigo severity level and clinical
时间窗: Visit1 to Visit 5
次要结局
- To evaluate the effectiveness of prochlorperazine in acute vertigo patients, by assessing(change in the severity of vertigo symptoms through improvement in nystagmus grading,)
研究者
研究点 (28)
Loading locations...
相似试验
已完成
4 期
Study to Evaluate the Safety and Tolerability of Mucinex™(Guaifenesin) 600 mg Extended-Release Bi-Layer Tablets in the Treatment of Otherwise Healthy Patients With Symptoms of Cough, Thickened Mucus and Chest CongestionHealthy SubjectsNCT03725085Reckitt Benckiser LLC552
已完成
不适用
A Post-Marketing Study of Alexa Medium for Сorrection of the Lips Volume LossNCT06961305Institute Hyalual GmbH69
终止
不适用
European eCLIPS™ Safety, Feasibility and Efficacy StudySaccular AneurysmIntracranial AneurysmNCT02607501Evasc Medical Systems Corp.20
已完成
4 期
Study of Voncento® in Subjects With Von Willebrand DiseaseVon Willebrand DiseaseNCT02552576CSL Behring26
终止
不适用
Triathlon PSR Outcomes StudyArthroplastyKneeNCT04618770Stryker Orthopaedics37