Post Marketing Observational Study to Assess the Effectiveness and Safety of Prochlorperazine In Patients with Acute Vertigo

A Prospective, Multicenter, Open-Label, Single-Arm, Post Marketing Observational Study to Assess the Effectiveness and Safety of Prochlorperazine In Patients with Acute Vertigo

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2022/01/039287

Enrollment

1708

Registered

2022-01-10

Start date

Unknown

Completion date

Unknown

Last updated

2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: G939- Disorder of brain, unspecified

Interventions

None listed

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex in the age group of 18-65 years. 2. Patients diagnosed with Meniere’s disease, vestibular neuritis, labyrinthitis, or post-operative vertigo. 3. Patients willing to participate in the study and sign an informed consent form

Exclusion criteria

Exclusion criteria: 1. Patients diagnosed with BPPV. 2. Patients with history of psychiatric illness. 3. Patients on anti-psychotic or anti-depressant medication. 4. Patients with history of cardiovascular, kidney or liver disorder. 5. Patients requiring hospitalization for any cause. 6. Patients with suspected or established subcortical brain damage, with or without hypothalamic damage. 7. Pregnant and nursing women. 8. Women with childbearing potential who are not practicing a reliable method of birth control. 9. Patients with a known history of hypersensitivity to phenothiazine derivatives

Design outcomes

Primary

Measure	Time frame
To evaluate the effectiveness of prochlorperazine in acute vertigo patients, by assessing clinical response based on the scale for vestibular vertigo severity level and clinical response evaluation (SVVSLCRE), from baseline to post-treatmentTimepoint: Visit1 to Visit 5	—

Secondary

Measure	Time frame
To evaluate the effectiveness of prochlorperazine in acute vertigo patients, by assessing change in the severity of vertigo symptoms through improvement in nystagmus grading, from baseline to post-treatment. 2. Safety and tolerability: a) To evaluate the safety of prochlorperazine, in acute vertigo patients, from baseline to end of study. b) To evaluate the tolerability of prochlorperazine, in acute vertigo patients, posttreatment. 3. To evaluate relief in vertigo-associated symptoms, in acute vertigo patients, from baseline to post-treatment.Timepoint: Visit 1 to Visit 5	—

Measure

Time frame

To evaluate the effectiveness of prochlorperazine in acute vertigo patients, by assessing change in the severity of vertigo symptoms through improvement in nystagmus grading, from baseline to post-treatment. 2. Safety and tolerability: a) To evaluate the safety of prochlorperazine, in acute vertigo patients, from baseline to end of study. b) To evaluate the tolerability of prochlorperazine, in acute vertigo patients, posttreatment. 3. To evaluate relief in vertigo-associated symptoms, in acute vertigo patients, from baseline to post-treatment.Timepoint: Visit 1 to Visit 5

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Countries

India

Contacts

Public ContactVairamuthu Ammaiyappan

Abbott Healthcare Pvt. Ltd.

anuja.sawant1@abbott.com8657459168

Outcome results