Health Condition 1: H811- Benign paroxysmal vertigo
Conditions
Interventions
Intervention1: Prochlorperazine Maleate 5 mg - Mouth Dissolving Tablet: In this study patients will be
prescribed Prochlorperazine 5mg tablet TID, for a period of 3 days.
Control Intervention1: NIL: N
Sponsors
Abbott Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. 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. 2. 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.
Exclusion criteria
Exclusion criteria: 1. Patients on prochlorperazine or any other anti-vertigo therapy drugs in the past 15 days. 2. Patients with a history of psychiatric illness or on anti-psychotic or anti-depressant medication in the past 6 months. 3. Patients with a history of cardiovascular, kidney, or liver disorders. 4. Patients with suspected or established subcortical brain damage, with or without hypothalamic damage. 5. Females who are pregnant/planning to become pregnant/not ready to use contraceptive measures or are lactating. 6. Patients with a known history of hypersensitivity to phenothiazine derivatives. 7. Participants in any clinical trial in past 30 days before enrolment. 8. Patients with a history of any malignancy. 9. 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. 10. Patients who are on concomitant medications such as anticholinergics, barbiturates, beta-blockers, cisapride, sparfloxacin, guanethidine, Metrizamide, Paroxetine, antihypertensives.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of prochlorperazine 5mg Tablet in the acute phase in patients diagnosed with BPPV.Timepoint: Day 1 and 4 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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.Timepoint: Day 1 and 4 | — |
Countries
India
Contacts
Public ContactDr Shivani Acharya
Abbott Healthcare Private Limited
Outcome results
None listed