Haloperidol vs Conventional Therapy for Gastroparesis

Gastroparesis Clinical Trial

— HATGAS  

Official title:

Haloperidol vs Conventional Therapy for Gastroparesis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02057549
• Other study ID #: 13040380
• Status: Terminated
• Phase: Phase 4
• First received: July 29, 2013
• Last updated: January 30, 2017
• Start date: November 2012
• Est. completion date: November 2016

Study information

• Verified date: May 2016
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 33
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastroparesis

Intervention

Drug:
• Haloperidol
adding haloperidol to conventional therapy

Locations

Country	Name	City	State
United States	Lyndon Baines Johnson General Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptoms relief - defined as improvement on mean change in Liker pain scale 1-5	"Symptom relief" - is defined as improvement on mean change in Liker pain scale 1-5	pt will be evaluated at the time right prior to medication administration then in 15min intervals up to 60min.
Secondary	Time frame for discharge	The "time frame" starts from the moment of receiving the study drug to the time when the decision for final disposition is made. Usually after symptoms are controlled, patients are given a PO challenge (food or drink) in order to establish if they are OK to go home. If symptoms return, additional medications are given, the treatment is consider failed and they are admitted to the Hospital.; Patients will not be followed up if admitted to any service. The study ends when final disposition is made.; Patients follow up after final disposition is not part of the study and will not be done.	we estimate the time frame to be 2 years