Trial Outcomes & Findings for Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation (NCT NCT03110900)
NCT ID: NCT03110900
Last Updated: 2018-06-11
Results Overview
Change in agitation level on the PANSS from baseline up to 120 minutes -- terminated by sponsor before results available
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
2 participants
Primary outcome timeframe
120 minutes
Results posted on
2018-06-11
Participant Flow
Participant milestones
| Measure |
Haloperidol + Lorazepam
IM haloperidol 5mg + IM lorazepam 2mg + placebo inhaler
Haloperidol + lorazepam: Haloperidol + lorazepam + placebo
|
Loxapine
Inhaled loxapine 10mg + IM normal saline
Loxapine: loxapine + placebo
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Haloperidol + Lorazepam
IM haloperidol 5mg + IM lorazepam 2mg + placebo inhaler
Haloperidol + lorazepam: Haloperidol + lorazepam + placebo
|
Loxapine
Inhaled loxapine 10mg + IM normal saline
Loxapine: loxapine + placebo
|
|---|---|---|
|
Overall Study
Sponsor withdrew
|
1
|
1
|
Baseline Characteristics
Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation
Baseline characteristics by cohort
| Measure |
Haloperidol + Lorazepam
n=1 Participants
IM haloperidol 5mg + IM lorazepam 2mg + placebo inhaler
Haloperidol + lorazepam: Haloperidol + lorazepam + placebo
|
Loxapine
n=1 Participants
Inhaled loxapine 10mg + IM normal saline
Loxapine: loxapine + placebo
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
>18 years <99
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 120 minutesPopulation: No data was collected because the sponsor terminated the study before any data could be collected.
Change in agitation level on the PANSS from baseline up to 120 minutes -- terminated by sponsor before results available
Outcome measures
Outcome data not reported
Adverse Events
Haloperidol + Lorazepam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Loxapine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Michael Wilson, M.D.
University of Arkansas for Medical Sciences
Phone: (501) 686-5515
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place