Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Patients With Nausea
Overview[ - collapse ][ - ]
| 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. |
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| Condition | Nausea and Vomiting |
| Intervention | Drug: lorazepam Drug: diphenhydramine hydrochloride Drug: haloperidol Other: placebo |
| Phase | N/A |
| Sponsor | Virginia Commonwealth University |
| Responsible Party | Virginia Commonwealth University |
| ClinicalTrials.gov Identifier | NCT01556932 |
| First Received | March 13, 2012 |
| Last Updated | December 18, 2013 |
| Last verified | December 2013 |
Tracking Information[ + expand ][ + ]
| First Received Date | March 13, 2012 |
|---|---|
| Last Updated Date | December 18, 2013 |
| Start Date | March 2012 |
| Estimated Primary Completion Date | March 2014 |
| Current 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. |
| Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
| Brief Title | Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Patients With Nausea |
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| 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 |
| Brief 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. |
| 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. |
| Study Type | Interventional |
| Study Phase | N/A |
| Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care |
| Condition | Nausea and Vomiting |
| Intervention | Drug: lorazepam Given topically Other Names: AtivanDrug: diphenhydramine hydrochloride Given topically Other Names:
Given topically Other Names:
Given topically Other Names: PLCB |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Active, not recruiting |
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| Estimated Enrollment | 20 |
| Estimated Completion Date | March 2014 |
| Estimated Primary Completion Date | March 2014 |
| Eligibility 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01556932 |
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| Other Study ID Numbers | MCC-14141 |
| Has Data Monitoring Committee | Yes |
| Information Provided By | Virginia Commonwealth University |
| Study Sponsor | Virginia Commonwealth University |
| Collaborators | National Cancer Institute (NCI) |
| Investigators | Principal Investigator: Devon Fletcher Virginia Commonwealth University |
| Verification Date | December 2013 |
Locations[ + expand ][ + ]
| Virginia Commonwealth University | Richmond, Virginia, United States, 23298 |
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