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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-01968 | Registry Identifier | CTRP | |
| PEP-10-174-1-PCSM | Other Grant/Funding Number | American Cancer Society |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| American Cancer Society, Inc. | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| lorazepam | Drug | Given topically |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Lorazepam, Diphenyhydramine, Haloperidol Absorption | Level of lorazepam absorption measured by the serum concentration of the drug | 4 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Side Effects | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Smith | Virginia Commonwealth University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University/Massey Cancer Center | Richmond | Virginia | 23298 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I | Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I | Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Lorazepam, Diphenyhydramine, Haloperidol Absorption | Level of lorazepam absorption measured by the serum concentration of the drug | Posted | Mean | Standard Deviation | ng/ml | 4 hours |
|
|
4 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I | Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas J. Smith, MD | Virginia Commonwealth University | 804-828-9723 | tsmith5@mcvh-vcu.edu |
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| ID | Term |
|---|---|
| D008140 | Lorazepam |
| D004155 | Diphenhydramine |
| D006220 | Haloperidol |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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| diphenhydramine hydrochloride |
| Drug |
Given topically |
|
|
| haloperidol | Drug | Given topically |
|
|
| questionnaire administration | Other | Ancillary studies |
|
| laboratory biomarker analysis | Other | Correlative studies |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
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| Secondary | Side Effects | Posted | Number | Total number of side effects | 3 months |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
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| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
| D001559 | Benzhydryl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D002090 | Butyrophenones |
| D007659 | Ketones |