NCT01827293

Brief Summary

This study was a prospective, randomized, double-blind, parallel group clinical trial designed to compare the efficacy of intravenous (IV) promethazine and lorazepam for the treatment of peripheral vertigo in Emergency Department setting.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2013

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

April 2, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

June 14, 2013

Status Verified

June 1, 2013

Enrollment Period

2 months

First QC Date

April 2, 2013

Last Update Submit

June 13, 2013

Conditions

Peripheral Vertigo.

Outcome Measures

Primary Outcomes (1)

  • Mean change in vertigo intensity.

    The primary efficacy outcome was the mean change in the vertigo intensity score between pre- and post-intervention at 2 hours after administration of study medications.

    At 2 hours after intervention.

Secondary Outcomes (1)

  • Efficacy and Safety outcome measures (nausea change-second dose-adverse events).

    At 2-8 hours after intervention.

Study Arms (2)

Promethazine

ACTIVE COMPARATOR

IV promethazine (25 mg)

Drug: PromethazineDrug: Lorazepam

lorazepam

ACTIVE COMPARATOR

IV lorazepam (2 mg)

Drug: PromethazineDrug: Lorazepam

Interventions

PromethazineDRUG
Promethazinelorazepam
LorazepamDRUG
Promethazinelorazepam

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 18 years or older
  • Background history of positional vertigo

You may not qualify if:

  • Unable to provide informed consent
  • Pregnant or possibly pregnant
  • Known allergy to study medications
  • Use of antiemetic agents in the previous 24 hours
  • Evidence of drug-induced vertigo or orthostatic hypotension
  • Central pathologies/central origin for vertigo

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurology, Emam Hossein Hospital

Tehran, Nezam Abad, 17666-33815, Iran

Location

MeSH Terms

Conditions

Vertigo

Interventions

PromethazineLorazepam

Condition Hierarchy (Ancestors)

Vestibular DiseasesLabyrinth DiseasesEar DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PropylaminesAminesOrganic ChemicalsPhenothiazinesSulfur CompoundsHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsBenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-Ring

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

April 2, 2013

First Posted

April 9, 2013

Study Start

April 1, 2013

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

June 14, 2013

Record last verified: 2013-06

Locations

IR(1)