- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02057549
Haloperidol vs Conventional Therapy for Gastroparesis (HATGAS)
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77026
- Lyndon Baines Johnson General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
Intravenous dose of haloperidol 5 mg.
Other Names:
|
Active Comparator: 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Pain Relief as Indicated by Number of Participants Not Requesting Additional Pain Medication
Time Frame: 1 hour after study medication given
|
1 hour after study medication given
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants Admitted to the Hospital After Emergency Department Visit
Time Frame: 2 hours after study medication given
|
2 hours after study medication given
|
|
Emergency Department Length of Stay (EDLOS)
Time Frame: at the time the decision for final disposition is made (about 8 hours)
|
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. |
at the time the decision for final disposition is made (about 8 hours)
|
Pain Score as Measured by a Visual Analogue Scale (VAS)
Time Frame: before study medication given
|
The Visual Analogue Scale (VAS) ranges from 0-10, with 0 being the absence of pain and 10 the worst imaginable pain.
|
before study medication given
|
Pain Score as Measured by a Visual Analogue Scale (VAS)
Time Frame: 1 hour after study medication given
|
The Visual Analogue Scale (VAS) ranges from 0-10, with 0 being the absence of pain and 10 the worst imaginable pain.
|
1 hour after study medication given
|
Nausea Score as Measured by a Visual Analogue Scale (VAS)
Time Frame: before study medication given
|
The Visual Analogue Scale (VAS) ranges from 1-5, with 1 being minimal nausea and 5 being severe nausea.
|
before study medication given
|
Nausea Score as Measured by a Visual Analogue Scale (VAS)
Time Frame: 1 hour after study medication given
|
The Visual Analogue Scale (VAS) ranges from 1-5, with 1 being minimal nausea and 5 being severe nausea.
|
1 hour after study medication given
|
Nausea Relief as Indicated by Number of Participants Not Requesting Additional Antiemetic Medication
Time Frame: 1 hour after study medication given
|
1 hour after study medication given
|
Collaborators and Investigators
Investigators
- Principal Investigator: Carlos J Roldan, MD, University of Texas
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neurologic Manifestations
- Gastrointestinal Diseases
- Stomach Diseases
- Paralysis
- Gastroparesis
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Dopamine Agents
- Dopamine Antagonists
- Anti-Dyskinesia Agents
- Haloperidol
- Haloperidol decanoate
Other Study ID Numbers
- 13040380
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Gastroparesis
-
Johns Hopkins UniversityCompletedDiabetic Gastroparesis | Idiopathic Gastroparesis | Gastroparesis PostoperativeUnited States
-
Johns Hopkins Bloomberg School of Public HealthNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedGastroparesis | Diabetic Gastroparesis | Idiopathic GastroparesisUnited States
-
Vanda PharmaceuticalsRecruitingGastroparesis | Diabetic Gastroparesis | Idiopathic GastroparesisUnited States
-
Neurogastrx, Inc.CompletedDiabetic Gastroparesis | Idiopathic GastroparesisUnited States
-
Texas Tech University Health Sciences Center, El...CompletedDiabetic Gastroparesis | Idiopathic GastroparesisUnited States
-
TakedaCompletedDiabetic Gastroparesis | Idiopathic GastroparesisUnited States
-
Johns Hopkins Bloomberg School of Public HealthJohns Hopkins University; Massachusetts General Hospital; National Institute... and other collaboratorsActive, not recruitingGastroparesis | Diabetic Gastroparesis | Idiopathic GastroparesisUnited States
-
Millennium Pharmaceuticals, Inc.CompletedDiabetic Gastroparesis | Idiopathic GastroparesisUnited States, Belgium, Japan, Poland
-
Vanderbilt University Medical CenterNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Enrolling by invitationFunctional Dyspepsia | Diabetics Without Symptoms of Gastroparesis | Diabetic Gastroparesis | Idiopathic Gastroparesis | Total or Partial Gastrectomy | Chronic NauseaUnited States
-
University of Erlangen-Nürnberg Medical SchoolNot yet recruiting
Clinical Trials on Haloperidol
-
New York State Psychiatric InstituteNational Institute of Mental Health (NIMH)CompletedPsychosis | Alzheimer's Disease | AgitationUnited States
-
University Hospitals Cleveland Medical CenterCase Western Reserve UniversityCompletedPatient NoncomplianceUnited States
-
Centre Hospitalier St AnneEtablissement Public de Santé Barthélemy Durand; Groupe Hospitalier Paul GuiraudNot yet recruitingSchizophrenia; PsychosisFrance
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)Terminated
-
Radboud University Medical CenterZonMw: The Netherlands Organisation for Health Research and DevelopmentCompleted
-
Zealand University HospitalCopenhagen Trial Unit, Center for Clinical Intervention Research; Scandinavian... and other collaboratorsActive, not recruitingDeliriumDenmark, Finland, Italy, United Kingdom
-
Hospital General Universitario Gregorio MarañonUnknownLabor Pain | Labor Onset | Parturition | Natural Childbirth | Humanizing Deliver | First Labor StageSpain
-
Asan Medical CenterSeoul National University HospitalCompleted
-
Khon Kaen UniversityCompleted
-
Case Western Reserve UniversityNational Institute of Mental Health (NIMH)CompletedSchizophrenia | Schizo Affective Disorder | Medication NonadherenceTanzania