A Phase 3 interventional study of Diazepam 5mg and Diazepam 10 mg in Vertigo, Peripheral, sponsored by University of Monastir. Not yet recruiting. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-04-02.
Sponsored by University of Monastir · Phase 3, Interventional, and Treatment
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
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. The study should be reviewed and receive approval from the institutional review board. Principles of the Helsinki Declaration are considered All patients should provide their informed consent prior to enrollment.
187 studies on the registry are indexed under Vertigo; 27 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 73 across 138 interventional studies indexed under Vertigo.
Browse Vertigo studies →University of Monastir is the lead sponsor of 114 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria;
Exclusion Criteria: -Patients aged > 70 years as central vertigo , -patients with a focal neurologic deficit, pregnancy, history of allergic reaction or to any of the test drugs, history of enrolment in a previous clinical drug trial,
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Diazepam 5mg
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.
Drug: Diazepam 10 mg
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.
Drug: Placebo
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.
Also known as: diazepam(B)
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.
Also known as: diazepam(C)
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.
Also known as: A
Visual analogue scale (VAS)-3H
the frequency of vertigo resolution defined as a reduction of at least 50% in VAS at 3-hour(VAS-3H) compared to baseline VAS (VAS baseline) during movement (VAS ambulation).
Time frame: 3 hours
the Delta-VAS
the delta VAS was calculated as \[(VAS baseline- VAS3H)/VAS baseline\]\*100
Time frame: 3 hous
the time required to reach the resolution of the vertigo crisis
the time required to reach the resolution of the vertigo crisis
Time frame: 3 hours
Patients satisfaction
patient satisfaction with likert scale
Time frame: 3 hours
number of patients with adverse effects
number of patients with adverse effects
Time frame: 3 hours
No study locations are listed for this record.
Start is estimated for May 2024; primary completion for Dec 2025, 19 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Diazepam