Trial Outcomes & Findings for Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers (NCT NCT01204255)

NCT ID: NCT01204255

Last Updated: 2017-11-17

Results Overview

Level of lorazepam absorption measured by the serum concentration of the drug

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 11 participants
• Primary outcome timeframe: 4 hours
• Results posted on: 2017-11-17

Participant Flow

Participant milestones

Measure	Arm I Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
Overall Study STARTED	11
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers

Baseline characteristics by cohort

Measure	Arm I n=11 Participants Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	11 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	37.7 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 4 hours

Level of lorazepam absorption measured by the serum concentration of the drug

Outcome measures

Measure	Application of Lorazepam, Diphenhydramine, Haloperidol n=10 Participants Topical application of lorazepam, diphenhydramine, haloperidol
Lorazepam, Diphenyhydramine, Haloperidol Absorption lorazepam absorption	0 ng/ml Standard Deviation 0
Lorazepam, Diphenyhydramine, Haloperidol Absorption diphenhydramine absorption	.08 ng/ml Standard Deviation .12
Lorazepam, Diphenyhydramine, Haloperidol Absorption haloperidol absorption	0 ng/ml Standard Deviation 0

SECONDARY outcome

Timeframe: 3 months

Outcome measures

Measure	Application of Lorazepam, Diphenhydramine, Haloperidol n=10 Participants Topical application of lorazepam, diphenhydramine, haloperidol
Side Effects	0 Total number of side effects

Adverse Events

Arm I

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

Thomas J. Smith, MD

Virginia Commonwealth University

Phone: 804-828-9723

Email: tsmith5@mcvh-vcu.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place