Trials / Terminated
TerminatedNCT03110900
Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation
A Randomized Double-blind Multicenter Double-dummy Non-inferiority Trial of Inhaled Loxapine and Intramuscular Haloperidol + Lorazepam for the Reduction of Agitation
- Status
- Terminated
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- University of Arkansas · Academic / Other
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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.
Detailed description
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
| Type | Name | Description |
|---|---|---|
| DRUG | Haloperidol + lorazepam | Haloperidol + lorazepam + placebo |
| DRUG | Loxapine | loxapine + placebo |
Timeline
- Start date
- 2017-09-30
- Primary completion
- 2018-04-04
- Completion
- 2018-04-04
- First posted
- 2017-04-12
- Last updated
- 2018-06-11
- Results posted
- 2018-06-11
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03110900. Inclusion in this directory is not an endorsement.