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A Randomized Trial of the Effectiveness of Topical "ABH Gel" (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) Versus Placebo in Patients With Nausea

18 Years
Open (Enrolling)
Nausea and Vomiting

Thank you

Trial Information

A Randomized Trial of the Effectiveness of Topical "ABH Gel" (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) Versus Placebo in Patients With Nausea


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.

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

Change in numeric rating scale in self-reported nausea on a 0-10 scale

Outcome Description:

A reliable and valid instrument for assessing relevant symptoms (on a scale of 0, 1, 2, 3 or 4) including Lack of energy, Lack of appetite, Pain, Dry mouth, Weight loss, Feeling drowsy, Shortness of breath, Constipation, Difficulty sleeping, Difficulty concentrating, and Nausea. Patients' demographics, adverse events, and treatment information, will be listed and summary descriptive statistics will be calculated. A two-sample t-test will be used to compare if the ABH gel is not better than the placebo gel. A repeated measure analysis will be used to compare the two treatment groups.

Outcome Time Frame:

From baseline to 60 minutes

Safety Issue:


Principal Investigator

Devon Fletcher

Investigator Role:

Principal Investigator

Investigator Affiliation:

Virginia Commonwealth University


United States: Institutional Review Board

Study ID:




Start Date:

March 2012

Completion Date:

March 2014

Related Keywords:

  • Nausea and Vomiting
  • Nausea
  • Vomiting



Virginia Commonwealth University Richmond, Virginia