Haloperidol vs Conventional Therapy for Gastroparesis

NCT ID: NCT02057549

Last Updated: 2017-08-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2016-11-30

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.

Conditions

Gastroparesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Haloperidol plus Conventional Therapy

Intravenous dose of haloperidol 5 mg in addition to conventional therapy. Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.

Group Type: EXPERIMENTAL

Haloperidol

Intervention Type: DRUG

Intravenous dose of haloperidol 5 mg.

Conventional Therapy alone

Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.

Group Type: ACTIVE_COMPARATOR

Conventional Therapy

Intervention Type: DRUG

Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.

Interventions

Haloperidol

Intravenous dose of haloperidol 5 mg.

Intervention Type: DRUG

Conventional Therapy

Conventional Therapy includes hydration via IV fluids, pain control with analgesics (usually opiates) frequently requiring multiple doses, also antiemetics (often requires multiple doses and different agents in attempts to control nausea and vomiting within this population), in addition to electrolytes abnormalities corrections as needed.

Intervention Type: DRUG

Other Intervention Names

Haldol

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Carlos Roldan

MD, Associate professor in Emergency Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Carlos J Roldan, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

Lyndon Baines Johnson General Hospital

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28646590 (View on PubMed)

Other Identifiers

13040380

Identifier Type: -

Identifier Source: org_study_id