HealthyNCT01204255

Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers

A study testing lorazepam, diphenhydramine hydrochloride and haloperidol in people with Healthy, run by Virginia Commonwealth University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Healthy
What is being tested?: lorazepam, diphenhydramine hydrochloride and haloperidol
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11 participants
Where: 1 siteUnited States
Study dates: 15 Nov 2010to 17 May 2011
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298

Other trials in United States

About this study

Official title: Absorption of "ABH Gel" (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) From the Skin of Normal Volunteers

Read the detailed description

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: Healthy
Being tested: lorazepam, diphenhydramine hydrochloride, haloperidol, questionnaire administration, laboratory biomarker analysis
Keywords: healthy, no evidence of disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

lorazepamDrug
Also called Ativan
Given topically
diphenhydramine hydrochlorideDrug
Also called Benadryl, Bendylate, Eldadryl, SK-Diphenhydramine
Given topically
haloperidolDrug
Also called Haldol, McN-JR-1625, R-1625
Given topically
questionnaire administrationOther
Ancillary studies
laboratory biomarker analysisOther
Correlative studies

Study groups in NCT01204255
Study group	Role	What they receive
Arm I	Experimental	Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes. Receives: Drug: lorazepam; Drug: diphenhydramine hydrochloride; Drug: haloperidol; Other: questionnaire administration; Other: laboratory biomarker analysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Lorazepam, Diphenyhydramine, Haloperidol Absorption
Level of lorazepam absorption measured by the serum concentration of the drug
Measured: 4 hours

Secondary outcomes (1)

Side Effects
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Nov 201017 May 2011

First posted17 Sep 2010 (estimated)
Study start15 Nov 2010
Primary completion18 Apr 2011
Study completion17 May 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HealthyStudies of the same condition, open and under way.
More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 11 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01204255
Sponsor's protocol ID: MCC-13108
Other IDs: NCI-2010-01968, PEP-10-174-1-PCSM
Status last verified: Oct 2017
First submitted: 15 Sep 2010
Last updated: 17 Nov 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Absorption of "ABH Gel" (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) From the Skin of Normal Volunteers
ClinicalTrials.gov ID: NCT01204255
Acronym / sponsor ID: MCC-13108
Conditions: Healthy
Keywords: healthy, no evidence of disease
Study type: Interventional
Recruitment status: Completed
Enrolment: 11 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Collaborators: National Cancer Institute (NCI), American Cancer Society, Inc.
Study start: 15 Nov 2010 (actual)
Primary completion: 18 Apr 2011 (actual)
Study completion: 17 May 2011 (actual)
First posted: 17 Sep 2010 (estimated)
Results: Posted 5 Aug 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Arm I	Experimental	Drug: lorazepam, Drug: diphenhydramine hydrochloride, Drug: haloperidol, Other: questionnaire administration, Other: laboratory biomarker analysisPatients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
lorazepamAlso: AtivanGiven topically	Drug	Arm I
diphenhydramine hydrochlorideAlso: Benadryl, Bendylate, Eldadryl, SK-DiphenhydramineGiven topically	Drug	Arm I
haloperidolAlso: Haldol, McN-JR-1625, R-1625Given topically	Drug	Arm I
questionnaire administrationAncillary studies	Other	Arm I
laboratory biomarker analysisCorrelative studies	Other	Arm I

Primary outcome

Lorazepam, Diphenyhydramine, Haloperidol Absorption
Time frame: 4 hours
Level of lorazepam absorption measured by the serum concentration of the drug

1 secondary outcome

Side Effects
Time frame: 3 months

Results and safety

Results posted to the registry on 5 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Arm I	11	10

Primary outcome: Lorazepam, Diphenyhydramine, Haloperidol Absorption

Time frame: 4 hours. Mean (Standard Deviation). Unit: ng/ml

Measure	Application of Lorazepam, Diphenhydramine, Haloperidol n = 10
lorazepam absorption	0 (0)
diphenhydramine absorption	.08 (.12)
haloperidol absorption	0 (0)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 4 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Arm I	0 of 10 (0%)	0 of 10 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Thomas Smith principal investigator

Virginia Commonwealth University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing lorazepam, diphenhydramine hydrochloride and haloperidol in people with Healthy, run by Virginia Commonwealth University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Lorazepam, Diphenyhydramine, Haloperidol Absorption (time frame: 4 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01204255.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2017.