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Haloperidol vs Conventional Therapy for Gastroparesis (HATGAS)

Primary Purpose

Gastroparesis

Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Haloperidol
Conventional Therapy
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastroparesis

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lyndon Baines Johnson General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Haloperidol plus Conventional Therapy

Conventional Therapy alone

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Pain Relief as Indicated by Number of Participants Not Requesting Additional Pain Medication

Secondary Outcome Measures

Number of Participants Admitted to the Hospital After Emergency Department Visit
Emergency Department Length of Stay (EDLOS)
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.
Pain Score as Measured by a Visual Analogue Scale (VAS)
The Visual Analogue Scale (VAS) ranges from 0-10, with 0 being the absence of pain and 10 the worst imaginable pain.
Pain Score as Measured by a Visual Analogue Scale (VAS)
The Visual Analogue Scale (VAS) ranges from 0-10, with 0 being the absence of pain and 10 the worst imaginable pain.
Nausea Score as Measured by a Visual Analogue Scale (VAS)
The Visual Analogue Scale (VAS) ranges from 1-5, with 1 being minimal nausea and 5 being severe nausea.
Nausea Score as Measured by a Visual Analogue Scale (VAS)
The Visual Analogue Scale (VAS) ranges from 1-5, with 1 being minimal nausea and 5 being severe nausea.
Nausea Relief as Indicated by Number of Participants Not Requesting Additional Antiemetic Medication

Full Information

First Posted
July 29, 2013
Last Updated
July 14, 2017
Sponsor
The University of Texas Health Science Center, Houston
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1. Study Identification

Unique Protocol Identification Number
NCT02057549
Brief Title
Haloperidol vs Conventional Therapy for Gastroparesis
Acronym
HATGAS
Official Title
Haloperidol vs Conventional Therapy for Gastroparesis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Terminated
Why Stopped
PI left institution
Study Start Date
November 2012 (Actual)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Haloperidol plus Conventional Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Therapy alone
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
Haloperidol
Other Intervention Name(s)
Haldol
Intervention Description
Intravenous dose of haloperidol 5 mg.
Intervention Type
Drug
Intervention Name(s)
Conventional Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain Relief as Indicated by Number of Participants Not Requesting Additional Pain Medication
Time Frame
1 hour after study medication given
Secondary Outcome Measure Information:
Title
Number of Participants Admitted to the Hospital After Emergency Department Visit
Time Frame
2 hours after study medication given
Title
Emergency Department Length of Stay (EDLOS)
Description
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.
Time Frame
at the time the decision for final disposition is made (about 8 hours)
Title
Pain Score as Measured by a Visual Analogue Scale (VAS)
Description
The Visual Analogue Scale (VAS) ranges from 0-10, with 0 being the absence of pain and 10 the worst imaginable pain.
Time Frame
before study medication given
Title
Pain Score as Measured by a Visual Analogue Scale (VAS)
Description
The Visual Analogue Scale (VAS) ranges from 0-10, with 0 being the absence of pain and 10 the worst imaginable pain.
Time Frame
1 hour after study medication given
Title
Nausea Score as Measured by a Visual Analogue Scale (VAS)
Description
The Visual Analogue Scale (VAS) ranges from 1-5, with 1 being minimal nausea and 5 being severe nausea.
Time Frame
before study medication given
Title
Nausea Score as Measured by a Visual Analogue Scale (VAS)
Description
The Visual Analogue Scale (VAS) ranges from 1-5, with 1 being minimal nausea and 5 being severe nausea.
Time Frame
1 hour after study medication given
Title
Nausea Relief as Indicated by Number of Participants Not Requesting Additional Antiemetic Medication
Time Frame
1 hour after study medication given

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos J Roldan, MD
Organizational Affiliation
University of Texas
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lyndon Baines Johnson General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77026
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28646590
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.
Results Reference
derived

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Haloperidol vs Conventional Therapy for Gastroparesis

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