Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis

NCT05065567 | Terminated Phase 3 Results FDA Drug

• 1 other identifier: EGME#02-2021
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare two commonly used agents for the treatment of cyclic vomiting to see if one agent is inferior to the other in time to improvement in symptoms, need for repeat or rescue medications, treatment failures and complications/side effects.

Conditions

Cyclic Vomiting Syndrome

Outcome Measures

Primary Outcomes (6)

• Abdominal Pain

  change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale

  2 hours

• Nausea

  change in nausea on 0 (none) through 10 (worse possible nausea) on a scale

  2 hours

• Abdominal Pain

  change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale

  24 hours

• Nausea

  change in nausea on 0 (none) through 10 (worse possible nausea) on a scale

  24 hours

• Abdominal Pain

  change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale

  48 hours

• Nausea

  change in nausea on 0 (none) through 10 (worse possible nausea) on a scale

  48 hours

Secondary Outcomes (3)

• Treatment Success

  2 hours

• Treatment Success

  24 hours

• Treatment Success

  48 hours

Study Arms (3)

haloperidol

ACTIVE COMPARATOR

these patients will receive 5mg IM haloperidol

Drug: Haloperidol

droperidol

ACTIVE COMPARATOR

these patients will receive 2.5mg IV droperidol

Drug: Droperidol

ondansetron

ACTIVE COMPARATOR

these patients will receive 8mg IV ondansetron

Drug: Ondansetron 8mg

Interventions

Droperidol DRUG

Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV

droperidol

Haloperidol DRUG

Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM

haloperidol

Ondansetron 8mg DRUG

Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron

ondansetron

Eligibility Criteria

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

You may qualify if:

• adult patients with clinical diagnosis of cyclic vomiting in the ED

You may not qualify if:

• pregnancy, allergy to any of the study medicines

Sponsors & Collaborators

• Corewell Health South: lead

Study Sites (1)

Lakeland Regional Healthcare

Saint Joseph, Michigan, 49085, United States

Location

MeSH Terms

Conditions

Familial cyclic vomiting syndrome

Interventions

Droperidol; Haloperidol; Ondansetron

Intervention Hierarchy (Ancestors)

Butyrophenones; Ketones; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Carbazoles; Indoles; Heterocyclic Compounds, 3-Ring

Limitations and Caveats

Limitations: This study was terminated as the researchers were unable to enroll enough patients and too many patients were lost to follow up.

Results Point of Contact

• Title: Research Specialist
• Organization: SpectrumLakeland

rachelle.pichot@corewellhealth.org

(240)389-7340

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2021
• First Posted: October 4, 2021
• Study Start: August 30, 2021
• Primary Completion: November 20, 2023
• Study Completion: November 20, 2023
• Last Updated: May 21, 2025
• Results First Posted: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

US (1)