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Haloperidol vs Conventional Therapy for Gastroparesis (HATGAS)

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ClinicalTrials.gov Identifier: NCT02057549
Recruitment Status : Terminated (PI left institution)
First Posted : February 7, 2014
Results First Posted : July 13, 2017
Last Update Posted : August 17, 2017
Sponsor:
Information provided by (Responsible Party):
Carlos Roldan, The University of Texas Health Science Center, Houston

Tracking Information
First Submitted Date  ICMJE July 29, 2013
First Posted Date  ICMJE February 7, 2014
Results First Submitted Date  ICMJE May 9, 2017
Results First Posted Date  ICMJE July 13, 2017
Last Update Posted Date August 17, 2017
Actual Study Start Date  ICMJE November 2012
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 14, 2017)
Pain Relief as Indicated by Number of Participants Not Requesting Additional Pain Medication [ Time Frame: 1 hour after study medication given ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
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 ]
"Symptom relief" - is defined as improvement on mean change in Liker pain scale 1-5
Change History Complete list of historical versions of study NCT02057549 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: June 14, 2017)
  • 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 5, 2014)
Time frame for discharge [ Time Frame: we estimate the time frame to be 2 years ]
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Haloperidol vs Conventional Therapy for Gastroparesis
Official Title  ICMJE Haloperidol vs Conventional Therapy for Gastroparesis
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Gastroparesis
Intervention  ICMJE
  • Drug: Haloperidol
    Intravenous dose of haloperidol 5 mg.
    Other Name: Haldol
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Haloperidol
  • 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.
    Intervention: Drug: Conventional Therapy
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 5, 2014)
36
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date November 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02057549
Other Study ID Numbers  ICMJE 13040380
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Carlos Roldan, The University of Texas Health Science Center, Houston
Study Sponsor  ICMJE The University of Texas Health Science Center, Houston
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Carlos J Roldan, MD University of Texas
PRS Account The University of Texas Health Science Center, Houston
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP