Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers
Overview[ - collapse ][ - ]
| Purpose | 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. |
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| Condition | Focus of Study: Absorption of the Three Components in the Topical ABH Gel in Healthy Volunteers, and Determine if There Are Any Adverse Effects. |
| Intervention | Drug: lorazepam Drug: diphenhydramine hydrochloride Drug: haloperidol Other: questionnaire administration Other: laboratory biomarker analysis |
| Phase | N/A |
| Sponsor | Virginia Commonwealth University |
| Responsible Party | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier | NCT01204255 |
| First Received | September 15, 2010 |
| Last Updated | April 26, 2013 |
| Last verified | April 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | September 15, 2010 |
|---|---|
| Last Updated Date | April 26, 2013 |
| Start Date | November 2010 |
| Estimated Primary Completion Date | May 2011 |
| Current Primary Outcome Measures | Lorazepam, Diphenyhydramine, Haloperidol Absorption [Time Frame: 4 hours] [Designated as safety issue: No]Level of lorazepam absorption measured by the serum concentration of the drug |
| Current Secondary Outcome Measures | Side Effects [Time Frame: 3 months] [Designated as safety issue: Yes] |
Descriptive Information[ + expand ][ + ]
| Brief Title | Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers |
|---|---|
| Official Title | Absorption of "ABH Gel" (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) From the Skin of Normal Volunteers |
| 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. |
| 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. |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care |
| Condition | Focus of Study: Absorption of the Three Components in the Topical ABH Gel in Healthy Volunteers, and Determine if There Are Any Adverse Effects. |
| Intervention | Drug: lorazepam Given topically Other Names: AtivanDrug: diphenhydramine hydrochloride Given topically Other Names:
Given topically Other Names:
Ancillary studies Other: laboratory biomarker analysis Correlative studies |
| Study Arm (s) | Experimental: Arm I Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes. |
Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
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| Estimated Enrollment | 11 |
| Estimated Completion Date | May 2011 |
| Estimated Primary Completion Date | April 2011 |
| Eligibility Criteria | 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | Accepts Healthy Volunteers |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01204255 |
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| Other Study ID Numbers | MCC-13108 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Virginia Commonwealth University |
| Study Sponsor | Virginia Commonwealth University |
| Collaborators | National Cancer Institute (NCI) American Cancer Society, Inc. |
| Investigators | Principal Investigator: Thomas Smith Virginia Commonwealth University |
| Verification Date | April 2013 |
Locations[ + expand ][ + ]
| Virginia Commonwealth University/Massey Cancer Center | Richmond, Virginia, United States, 23298 |
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