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Haloperidol vs Conventional Therapy for Gastroparesis (HATGAS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by The University of Texas Health Science Center, Houston
Sponsor:
Information provided by (Responsible Party):
Carlos Roldan, The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT02057549
First received: July 29, 2013
Last updated: February 5, 2014
Last verified: January 2014
  Purpose

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


Condition Intervention Phase
Gastroparesis
Drug: Haloperidol
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Haloperidol vs Conventional Therapy for Gastroparesis

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Symptoms relief - defined as improvement on mean change in Liker pain scale 1-5 [ Time Frame: we estimate that the time frame will be 2 years ] [ Designated as safety issue: No ]
    "Symptom relief" - is defined as improvement on mean change in Liker pain scale 1-5


Secondary Outcome Measures:
  • Time frame for discharge [ Time Frame: we estimate the time frame to be 2 years ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 36
Study Start Date: November 2012
Estimated Study Completion Date: November 2015
Estimated Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Haloperidol + conventional care
an intravenous dose of 5mg haloperidol in addition to conventional therapy
Drug: Haloperidol
adding haloperidol to conventional therapy
Other Name: Haldol
No Intervention: Conventional Therapy alone
the control arm will receive conventional therapy.

Detailed Description:

Study Design This study is a prospective, double-blind randomized placebo controlled trial involving adult 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 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 SPSS statistical software (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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02057549

Contacts
Contact: Carlos J Roldan, MD Carlos.J.Roldan@uth.tmc.edu
Contact: Yashwant Chathampally, MD Yashwant.Chathampally@uth.tmc.edu

Locations
United States, Texas
Lyndon Baines Johnson General Hospital Recruiting
Houston, Texas, United States, 77026
Contact: Carlos J Roldan, MD       Carlos.J.Roldan@uth.tmc.edu   
Principal Investigator: Carlos J Roldan, MD         
Principal Investigator: Yashwant Chathampally, MD         
Sub-Investigator: Linda Paniagua, MD         
Sub-Investigator: Peter J Carlson, MD         
Sub-Investigator: Sonali Patel, MD         
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: Carlos J Roldan, MD University of Texas
  More Information

No publications provided

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
Study First Received: July 29, 2013
Last Updated: February 5, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Gastroparesis
Digestive System Diseases
Gastrointestinal Diseases
Neurologic Manifestations
Paralysis
Signs and Symptoms
Stomach Diseases
Haloperidol
Haloperidol decanoate
Anti-Dyskinesia Agents
Antiemetics
Antipsychotic Agents
Autonomic Agents
Central Nervous System Agents
Central Nervous System Depressants
Dopamine Agents
Dopamine Antagonists
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses
Tranquilizing Agents

ClinicalTrials.gov processed this record on November 27, 2014