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Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers

Information source: Virginia Commonwealth University
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Healthy, no Evidence of Disease; Nausea and Vomiting

Intervention: lorazepam (Drug); diphenhydramine hydrochloride (Drug); haloperidol (Drug); questionnaire administration (Other); laboratory biomarker analysis (Other)

Phase: N/A

Status: Not yet recruiting

Sponsored by: Virginia Commonwealth University

Official(s) and/or principal investigator(s):
Thomas Smith, Principal Investigator, Affiliation: Virginia Commonwealth University

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.

Clinical Details

Official title: Absorption of "ABH Gel" (AtivanŽ, Lorazepam; BenadrylŽ, Diphenhydramine; and HaldolŽ, Haloperidol Gel) From the Skin of Normal Volunteers

Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Level of drug absorption measured by the serum concentration of the drug

Secondary outcome: Side effects

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.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Virginia Commonwealth University/Massey Cancer Center, Richmond, Virginia 23298, United States
Additional Information

Starting date: September 2010
Last updated: September 15, 2010

Page last updated: October 04, 2010

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