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Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers

NCT ID: NCT01204255

Last Updated: 2017-11-17

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-15

Study Completion Date

2011-05-17

Brief Summary

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RATIONALE: Lorazepam, diphenhydramine hydrochloride, and haloperidol gel, when absorbed into the skin, may be an effective treatment for nausea and vomiting.PURPOSE: This clinical trial studies lorazepam, diphenhydramine hydrochloride, and haloperidol gel in healthy volunteers.

Detailed Description

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OBJECTIVES:I. To study the absorption of the three components in the topical ABH gel in 10 healthy volunteers, and determine if there are any adverse effects. OUTLINE: Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes. After completion of study treatment, patients are followed up for 5 hours.

Conditions

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Healthy

Keywords

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healthy, no evidence of disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Arm I

Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.

Group Type EXPERIMENTAL

lorazepam

Intervention Type DRUG

Given topically

diphenhydramine hydrochloride

Intervention Type DRUG

Given topically

haloperidol

Intervention Type DRUG

Given topically

questionnaire administration

Intervention Type OTHER

Ancillary studies

laboratory biomarker analysis

Intervention Type OTHER

Correlative studies

Interventions

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lorazepam

Given topically

Intervention Type DRUG

diphenhydramine hydrochloride

Given topically

Intervention Type DRUG

haloperidol

Given topically

Intervention Type DRUG

questionnaire administration

Ancillary studies

Intervention Type OTHER

laboratory biomarker analysis

Correlative studies

Intervention Type OTHER

Other Intervention Names

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Ativan Benadryl Bendylate Eldadryl SK-Diphenhydramine Haldol McN-JR-1625 R-1625

Eligibility Criteria

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Inclusion Criteria

* Completed a medical screening questionnaire
* English speaking
* No allergies to the drugs
* Able to complete the forms
* If a woman of childbearing age, agree to use contraception

Exclusion Criteria

* History of substance abuse, psychiatric disorder, acquired brain injury, the possibility of pregnancy (not using birth control, and of child bearing age)
* Use of any medication that would contraindicate benzodiazepine administration
* Pregnant or nursing
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

American Cancer Society, Inc.

OTHER

Sponsor Role collaborator

Virginia Commonwealth University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Thomas Smith

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

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Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2010-01968

Identifier Type: REGISTRY

Identifier Source: secondary_id

PEP-10-174-1-PCSM

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MCC-13108

Identifier Type: -

Identifier Source: org_study_id