Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Patients With Nausea

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Virginia Commonwealth University
ClinicalTrials.gov Identifier:
NCT01556932
First received: March 13, 2012
Last updated: December 18, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Nausea and Vomiting
Drug: lorazepam
Drug: diphenhydramine hydrochloride
Drug: haloperidol
Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Randomized Trial of the Effectiveness of Topical "ABH Gel" (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) Versus Placebo in Patients With Nausea

Resource links provided by NLM:


Further study details as provided by Virginia Commonwealth University:

Primary Outcome Measures:
  • Change in numeric rating scale in self-reported nausea on a 0-10 scale [ Time Frame: From baseline to 60 minutes ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in nausea score from baseline [ Time Frame: 60 minutes after application of ABH gel ] [ Designated as safety issue: No ]
  • Change in nausea score from baseline [ Time Frame: 120 minutes after application of ABH gel ] [ Designated as safety issue: No ]
  • Change in nausea score from baseline [ Time Frame: 180 minutes after application of ABH gel ] [ Designated as safety issue: No ]
  • Change in nausea score from baseline [ Time Frame: 240 minutes after application of ABH gel ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: March 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (ABH gel followed by placebo)
Patients apply lorazepam, diphenhydramine hydrochloride, and haloperidol gel topically over 2 minutes and placebo topically for 2 minutes.
Drug: lorazepam
Given topically
Other Name: Ativan
Drug: diphenhydramine hydrochloride
Given topically
Other Names:
  • Benadryl
  • Bendylate
  • Eldadryl
  • SK-Diphenhydramine
Drug: haloperidol
Given topically
Other Names:
  • Haldol
  • McN-JR-1625
  • R-1625
Other: placebo
Given topically
Other Name: PLCB
Placebo Comparator: Arm II (placebo)
Patients apply placebo topically over 2 minutes.
Other: placebo
Given topically
Other Name: PLCB

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01556932

Locations
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Virginia Commonwealth University
Investigators
Principal Investigator: Devon Fletcher Virginia Commonwealth University
  More Information

No publications provided

Responsible Party: Virginia Commonwealth University
ClinicalTrials.gov Identifier: NCT01556932     History of Changes
Other Study ID Numbers: MCC-14141, NCI-2012-00220
Study First Received: March 13, 2012
Last Updated: December 18, 2013
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Diphenhydramine
Haloperidol
Lorazepam
Promethazine
Haloperidol decanoate
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hypnotics and Sedatives
Central Nervous System Depressants
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Sensory System Agents
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on July 22, 2014