Haloperidol vs Conventional Therapy for Gastroparesis (HATGAS)
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| ClinicalTrials.gov Identifier: NCT02057549 |
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Recruitment Status :
Terminated
(PI left institution)
First Posted : February 7, 2014
Results First Posted : July 13, 2017
Last Update Posted : August 17, 2017
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Gastroparesis | Drug: Haloperidol Drug: Conventional Therapy | Phase 4 |
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 : | Interventional (Clinical Trial) |
| Actual Enrollment : | 36 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | Haloperidol vs Conventional Therapy for Gastroparesis |
| Actual Study Start Date : | November 2012 |
| Actual Primary Completion Date : | November 2016 |
| Actual Study Completion Date : | November 2016 |
| Arm | Intervention/treatment |
|---|---|
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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.
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Drug: Haloperidol
Intravenous dose of haloperidol 5 mg.
Other Name: Haldol |
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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.
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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. |
- Pain Relief as Indicated by Number of Participants Not Requesting Additional Pain Medication [ Time Frame: 1 hour after study medication given ]
- Number of Participants Admitted to the Hospital After Emergency Department Visit [ Time Frame: 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.
- 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.
- 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.
- 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.
- 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.
- Nausea Relief as Indicated by Number of Participants Not Requesting Additional Antiemetic Medication [ Time Frame: 1 hour after study medication given ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02057549
| United States, Texas | |
| Lyndon Baines Johnson General Hospital | |
| Houston, Texas, United States, 77026 | |
| Principal Investigator: | Carlos J Roldan, MD | University of Texas |
| Responsible Party: | Carlos Roldan, MD, Associate professor in Emergency Medicine, The University of Texas Health Science Center, Houston |
| ClinicalTrials.gov Identifier: | NCT02057549 History of Changes |
| Other Study ID Numbers: |
13040380 |
| First Posted: | February 7, 2014 Key Record Dates |
| Results First Posted: | July 13, 2017 |
| Last Update Posted: | August 17, 2017 |
| Last Verified: | July 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
Additional relevant MeSH terms:
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Gastroparesis Stomach Diseases Gastrointestinal Diseases Digestive System Diseases Paralysis Neurologic Manifestations Signs and Symptoms Analgesics Haloperidol Antiemetics Haloperidol decanoate Sensory System Agents Peripheral Nervous System Agents |
Physiological Effects of Drugs Autonomic Agents Gastrointestinal Agents Antipsychotic Agents Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Dopamine Antagonists Dopamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Anti-Dyskinesia Agents |