Clinical trial NCT02057549: Haloperidol vs Conventional Therapy for Gastroparesis
Official title: Haloperidol vs Conventional Therapy for Gastroparesis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Gastroparesis
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2014-02-07
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Randomized controlled trial comparing haloperidol combined with conventional therapy and conventional therapy alone in patients with symptomatic gastroparesis.

Detailed description: Study Design This study is a prospective, double-blind randomized placebo controlled trial involving adult emergency department (ED) patients who present with an acute exacerbation of gastroparesis. This study design will have two arms in the clinical trials. An experimental arm will receive an intravenous dose of haloperidol 5 mg in addition to conventional therapy, and the control arm will receive conventional therapy. Patients will be randomized as described below. Neither the physician nor the patient will be aware of the group to which the patient was randomized.

Methods Upon arrive at to the ED at the Memorial Hermann Hospital located in the Texas Medical Center; patients with gastroparesis (GP) exacerbation will be assessed for eligibility for enrollment in this trial by the clinicians on duty. Informed consent will be obtained from eligible patients that meet inclusion and exclusion criteria by trained ED residents. A 12 lead electrocardiogram will be performed to evaluate the presence of QT segment prolongation. Enrolled patients will be given 5 mg of intravenous haloperidol or equivalent volume of placebo pre-packaged and coded with a study ID number provided by the investigational pharmacy.

No unique identifiers or other PHI will be collected on enrolled patients. Information will also be recorded on the time elapsed from the time it took to provide the study medication and the time of the decision on disposition (admit or discharge). A record will be maintained if any additional medications including analgesics and antiemetics given to the patient before and after the study vial are given. Data will be collected on any adverse effects or complications the patients may experience (i.e. dystonic reactions, allergies etc.). After the data is collected at one hour for the primary outcome the trial will end and the physician will be unblended so they can choose subsequent medication.

All completed data collection forms will be dropped off in a secure locked mailbox and collected on a weekly basis by research staff. Collected forms will be housed in the ED office located in the Jesse Jones Library (JJL) 4th floor in a locked cabinet. Data will be entered electronically and analyzed using statistical package for the social sciences (SPSS) version 19.0. This database will be housed on a rights-protected research drive with limited access for viewing.

Informed Consent Patients will be notified of this study and they will be asked if they are interested in participating. If they are interested in participating, they will have the informed consent (IC) explained to them in either English or Spanish (Beaudoin, Nagdev, Merchant \& Becker, 2010). The patient will sign, date, and put the time on the IC. The consenter will also do the same. A copy of the IC will be made in the ED and given to the patient for their records. The original copy will be housed in the regulatory binder located in JJL.

Eligibility criteria: Inclusion Criteria:

* Previous diagnosis of GP including those without formal gastric emptying studies.
* Patients presenting with unresolving nausea, vomiting, and abdominal pain that is attributable to their GP.

Exclusion Criteria:

* History of QT prolongation or presence on a 12 leads electrocardiogram.
* Presence of concomitant acute abdominal pathology including but not limited to hepatobiliary disease, ischemia, and abdominal aneurysm.
* Prisoners
* Hypotension (systolic blood pressure below 90 mm Hg)
* Pregnant women
* Patients who are cognitively impaired and/or unable to consent for the study
* Age \<18
* Allergy to haloperidol

Primary outcomes:
measure: Pain Relief as Indicated by Number of Participants Not Requesting Additional Pain Medication
timeFrame: 1 hour after study medication given
Secondary outcomes:
measure: Number of Participants Admitted to the Hospital After Emergency Department Visit
timeFrame: 2 hours after study medication given
measure: Emergency Department Length of Stay (EDLOS)
timeFrame: at the time the decision for final disposition is made (about 8 hours)
measure: Pain Score as Measured by a Visual Analogue Scale (VAS)
timeFrame: before study medication given
measure: Pain Score as Measured by a Visual Analogue Scale (VAS)
timeFrame: 1 hour after study medication given
measure: Nausea Score as Measured by a Visual Analogue Scale (VAS)
timeFrame: before study medication given
measure: Nausea Score as Measured by a Visual Analogue Scale (VAS)
timeFrame: 1 hour after study medication given
measure: Nausea Relief as Indicated by Number of Participants Not Requesting Additional Antiemetic Medication
timeFrame: 1 hour after study medication given
Other outcomes:
Locations:
city: Houston
country: United States
facility: Lyndon Baines Johnson General Hospital
state: Texas
Study officials:
affiliation: University of Texas
name: Carlos J Roldan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roldan CJ, Chambers KA, Paniagua L, Patel S, Cardenas-Turanzas M, Chathampally Y. Randomized Controlled Double-blind Trial Comparing Haloperidol Combined With Conventional Therapy to Conventional Therapy Alone in Patients With Symptomatic Gastroparesis. Acad Emerg Med. 2017 Nov;24(11):1307-1314. doi: 10.1111/acem.13245. Epub 2017 Jul 26.