Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Patients With Nausea
Information source: Virginia Commonwealth University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nausea and Vomiting
Intervention: lorazepam (Drug); diphenhydramine hydrochloride (Drug); haloperidol (Drug); placebo (Other)
Phase: N/A
Status: Completed
Sponsored by: Virginia Commonwealth University Official(s) and/or principal investigator(s): Devon Fletcher, Principal Investigator, Affiliation: Virginia Commonwealth University
Summary
This randomized clinical trial studies lorazepam, diphenhydramine hydrochloride, and
haloperidol gel in patients with nausea. Lorazepam, diphenhydramine hydrochloride, and
haloperidol gel, when absorbed into the skin, may be an effective treatment for nausea and
vomiting.
Clinical Details
Official title: A Randomized Trial of the Effectiveness of Topical "ABH Gel" (AtivanŽ, Lorazepam; BenadrylŽ, Diphenhydramine; and HaldolŽ, Haloperidol Gel) Versus Placebo in Patients With Nausea
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Primary outcome: Change in numeric rating scale in self-reported nausea on a 0-10 scale
Secondary outcome: Change in nausea score from baselineChange in nausea score from baseline Change in nausea score from baseline Change in nausea score from baseline
Detailed description:
PRIMARY OBJECTIVES:
I. Evaluate the use of the gel in the treatment of nausea with a randomized, double blind,
placebo controlled, cross-over clinical trial. The clinically important effect is that the
gel will lead to a two point reduction in the severity of nausea compared to the placebo
over time.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel
topically over 2 minutes and placebo topically over 2 minutes.
ARM II: Patients apply placebo topically over 2 minutes.
After completion of study treatment, patients are followed up for up to 8 hours.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- English speaking
- No allergies to the drugs
- Able to complete the forms
- If a woman of childbearing age, agree to use contraception; women will be offered a
pregnancy test before doing the trial if they request one, as stated in the Informed
Consent Form
- Patients must have a self reported nausea score of at least 4 on a numeric rating
scale of 0-10 (zero being no nausea and ten being the worst possible nausea);
patients are not required to have vomiting
- Patients must have had or have cancer, or have had a consultation with the palliative
care team
- They must not have had any changes to their nausea program within the past 12 hours,
if on anti-emetics
- Patients must not have received chemotherapy within 5 days, unless it is a stable
oral chemotherapy drug such as capecitabine (Xeloda), erlotinib (Tarceva), or similar
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
- Children
Locations and Contacts
Virginia Commonwealth University, Richmond, Virginia 23298, United States
Additional Information
Starting date: March 2012
Last updated: January 8, 2015
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