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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

March 13, 2012
December 18, 2013
March 2012
March 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01556932 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Change in nausea score from baseline [ Time Frame: 30 minutes after application of ABH gel ] [ Designated as safety issue: No ]
  • 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: 90 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 ]
Not Provided
Not Provided
 
Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Patients With Nausea
A Randomized Trial of the Effectiveness of Topical "ABH Gel" (Ativan®, Lorazepam; Benadryl®, Diphenhydramine; and Haldol®, Haloperidol Gel) Versus Placebo in Patients With Nausea

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Nausea and Vomiting
  • 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
  • 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.
    Interventions:
    • Drug: lorazepam
    • Drug: diphenhydramine hydrochloride
    • Drug: haloperidol
    • Other: placebo
  • Placebo Comparator: Arm II (placebo)
    Patients apply placebo topically over 2 minutes.
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
March 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01556932
MCC-14141, NCI-2012-00220
Yes
Virginia Commonwealth University
Virginia Commonwealth University
National Cancer Institute (NCI)
Principal Investigator: Devon Fletcher Virginia Commonwealth University
Virginia Commonwealth University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP