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Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation

NCT03110900 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2018-06-11

Study results available
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Summary

The primary objective of this study is to determine the noninferiority of inhaled loxapine compared to intramuscular haloperidol/lorazepam on agitation reduction at 120 minutes.

Conditions

  • Agitation,Psychomotor
  • Haloperidol Causing Adverse Effects in Therapeutic Use
  • Lorazepam Causing Adverse Effects in Therapeutic Use
  • Loxapine Causing Adverse Effects in Therapeutic Use

Interventions

DRUG

Haloperidol + lorazepam

Haloperidol + lorazepam + placebo

DRUG

Loxapine

loxapine + placebo

Sponsors & Collaborators

  • Mount Sinai Hospital, Chicago

    collaborator OTHER

  • University of Arkansas

    lead OTHER

Principal Investigators

  • Michael P Wilson, MD · UAMS

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2018-04-04
Completion
2018-04-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03110900 on ClinicalTrials.gov