NCT01204255

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Nov 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

November 15, 2010

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 18, 2011

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2011

Completed
3 months until next milestone

Results Posted

Study results publicly available

August 5, 2011

Completed
Last Updated

November 17, 2017

Status Verified

October 1, 2017

Enrollment Period

5 months

First QC Date

September 15, 2010

Results QC Date

July 11, 2011

Last Update Submit

October 16, 2017

Conditions

Healthy

Keywords

healthy, no evidence of disease

Outcome Measures

Primary Outcomes (1)

  • Lorazepam, Diphenyhydramine, Haloperidol Absorption

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

    4 hours

Secondary Outcomes (1)

  • Side Effects

    3 months

Study Arms (1)

Arm I

EXPERIMENTAL

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

Drug: lorazepamDrug: diphenhydramine hydrochlorideDrug: haloperidolOther: questionnaire administrationOther: laboratory biomarker analysis

Interventions

lorazepamDRUG

Given topically

Also known as: Ativan
Arm I
diphenhydramine hydrochlorideDRUG

Given topically

Also known as: Benadryl, Bendylate, Eldadryl, SK-Diphenhydramine
Arm I
haloperidolDRUG

Given topically

Also known as: Haldol, McN-JR-1625, R-1625
Arm I
questionnaire administrationOTHER

Ancillary studies

Arm I
laboratory biomarker analysisOTHER

Correlative studies

Arm I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Virginia Commonwealth University/Massey Cancer Center

Richmond, Virginia, 23298, United States

Location

MeSH Terms

Interventions

LorazepamDiphenhydramineHaloperidol

Intervention Hierarchy (Ancestors)

BenzodiazepinonesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsEthylaminesAminesOrganic ChemicalsBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsButyrophenonesKetones

Results Point of Contact

Title
Thomas J. Smith, MD
Organization
Virginia Commonwealth University
tsmith5@mcvh-vcu.edu
804-828-9723

Study Officials

  • Thomas Smith

    Virginia Commonwealth University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 15, 2010

First Posted

September 17, 2010

Study Start

November 15, 2010

Primary Completion

April 18, 2011

Study Completion

May 17, 2011

Last Updated

November 17, 2017

Results First Posted

August 5, 2011

Record last verified: 2017-10

Locations

US(1)