Clinical trial

Efficacy and Safety of Intravenous Diazepam Given at 2 Different Doses Compared to Placebo in Acute Peripheral Vertigo: A Randomized Controlled Double Blinded Study

Name

Emergency department

Description

This is prospective, randomised double-blind study that will be conducted in the emergency department of 3 university hospitals (FB Monastir, Sahloul Sousse, and FH Sousse) to compare the efficacy of two doses of diazepam (Valium®) and placebo for the relief of acute periphery vertigo in the ED

Trial arms

Trial start

2024-05-01

Estimated PCD

2025-12-30

Trial end

2026-03-30

Status

Not yet recruiting

Phase

Early phase I

Treatment

Diazepam 5mg

For the intervention, patients will be randomly allocated into three groups. Each patient will be randomized to one of three treatment groups: diazepam 5 mg (5 mg/1 mL), . Medications will be diluted with 5 mL of normal saline solution slowly intravenously injected (over 5 minutes). The associate clinical research coordinator was responsible for preparation and dispensing the study drug. The investigators, treating physicians, nurses, and patients were blinded to the treatment.

Arms:

diazepam 5 mg

Other names:

diazepam(B)

Diazepam 10 mg

For the intervention, patients will be randomly allocated into three groups. Each patient will be randomized to one of three treatment groups: diazepam10 mg (5 mg/1 mL), . Medications will be diluted with 5 mL of normal saline solution slowly intravenously injected (over 5 minutes). The associate clinical research coordinator was responsible for preparation and dispensing the study drug. The investigators, treating physicians, nurses, and patients were blinded to the treatment.

Arms:

diazepam 10 mg

Other names:

diazepam(C)

Placebo

For the intervention, patients will be randomly allocated into three groups. Each patient will be randomized to one of three treatment groups:Placebo . Medications will be diluted with 5 mL of normal saline solution slowly intravenously injected (over 5 minutes). The associate clinical research coordinator was responsible for preparation and dispensing the study drug. The investigators, treating physicians, nurses, and patients were blinded to the treatment.

Arms:

placebo

Other names:

Size

1000

Primary endpoint

Visual analogue scale (VAS)-3H

3 hours

Eligibility criteria

Inclusion Criteria; * patients between 18 and 70 years of age * a chief complaint of acute peripheral vertigo (APV) (sensation of spinning, which was worsened by movement and sudden in onset) were eligible if the treating emergency physician diagnosed an episode of vertigo that was peripheral in nature. Exclusion Criteria: -Patients aged \> 70 years as central vertigo , -patients with a focal neurologic deficit, pregnancy, history of allergic reaction or contraindication to any of the test drugs, history of enrolment in a previous clinical drug trial, * history of recent ingestion (within 24 hours) of a sedative, antihistamine, antipsychotic, or opioid, * history of syncope or cardiac event, considerations of a central origin for vertigo -evidence of drug-induced vertigo or orthostatic hypotension -history of mental or neurological illness.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 1000, 'type': 'ESTIMATED'}}

Updated at

2024-04-02

1 organization

2 products

2 indications

Organization

University of Monastir

Product

Indication

Indication

Product