Haloperidol vs Conventional Therapy for Gastroparesis

NCT02057549 | Terminated Phase 4 Results

• 1 other identifier: 13040380
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastroparesis

Outcome Measures

Primary Outcomes (1)

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

  1 hour after study medication given

Secondary Outcomes (7)

• Number of Participants Admitted to the Hospital After Emergency Department Visit

  2 hours after study medication given

• Emergency Department Length of Stay (EDLOS)

  at the time the decision for final disposition is made (about 8 hours)

• Pain Score as Measured by a Visual Analogue Scale (VAS)

  before study medication given

• Pain Score as Measured by a Visual Analogue Scale (VAS)

  1 hour after study medication given

• Nausea Score as Measured by a Visual Analogue Scale (VAS)

  before study medication given

Study Arms (2)

Haloperidol plus Conventional Therapy

EXPERIMENTAL

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.

Drug: Haloperidol

Conventional Therapy alone

ACTIVE COMPARATOR

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.

Drug: Conventional Therapy

Interventions

Haloperidol DRUG

Intravenous dose of haloperidol 5 mg.

Also known as: Haldol

Haloperidol plus Conventional Therapy

Conventional Therapy DRUG

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 alone

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Lyndon Baines Johnson General Hospital

Houston, Texas, 77026, United States

Location

Related Publications (1)

• 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.

  PMID: 28646590 DERIVED

MeSH Terms

Conditions

Gastroparesis

Interventions

Haloperidol

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals

Results Point of Contact

• Title: Dr. Carlos J. Roldan MD
• Organization: The University of Texas Houston Health Science Center

croldan@mdanderson.org

713-792 6070

Study Officials

• Carlos J Roldan, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Associate professor in Emergency Medicine

Study Record Dates

• First Submitted: July 29, 2013
• First Posted: February 7, 2014
• Study Start: November 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 17, 2017
• Results First Posted: July 13, 2017

Record last verified: 2017-07

Locations

US (1)