Cyclic Vomiting SyndromePhase 3NCT05065567

Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis

A Phase 3 study testing Droperidol, Haloperidol and Ondansetron 8mg in people with Cyclic Vomiting Syndrome, run by Corewell Health South at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Cyclic Vomiting Syndrome
What is being tested?: Droperidol, Haloperidol and Ondansetron 8mg
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 32 participants
Where: 1 siteUnited States
Study dates: 30 Aug 2021to 20 Nov 2023
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

adult patients with clinical diagnosis of cyclic vomiting in the ED

Who cannot join

pregnancy, allergy to any of the study medicines

Trial locations and contacts

1 site in 1 country.

United States1 site

Lakeland Regional Healthcare
Saint Joseph, Michigan, 49085

Other trials in United States

About this study

Official title: A Comparison of Haloperidol 5mg IM vs Droperidol 2.5mg and Ondansetron for the Treatment of Hyperemesis in Cannabis Hyperemesis Syndrome

Conditions: Cyclic Vomiting Syndrome
Being tested: Droperidol, Haloperidol, Ondansetron 8mg
Medical subject headings: Familial cyclic vomiting syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DroperidolDrug
Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV
HaloperidolDrug
Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM
Ondansetron 8mgDrug
Patients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron

Study groups in NCT05065567
Study group	Role	What they receive
haloperidol	Active comparator	these patients will receive 5mg IM haloperidol Receives: Drug: Haloperidol
droperidol	Active comparator	these patients will receive 2.5mg IV droperidol Receives: Drug: Droperidol
ondansetron	Active comparator	these patients will receive 8mg IV ondansetron Receives: Drug: Ondansetron 8mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Abdominal Pain
change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale
Measured: 2 hours
Nausea
change in nausea on 0 (none) through 10 (worse possible nausea) on a scale
Measured: 2 hours
Abdominal Pain
change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale
Measured: 24 hours
Nausea
change in nausea on 0 (none) through 10 (worse possible nausea) on a scale
Measured: 24 hours
Abdominal Pain
change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale
Measured: 48 hours
Nausea
change in nausea on 0 (none) through 10 (worse possible nausea) on a scale
Measured: 48 hours

Secondary outcomes (3)

Treatment Success
both abdominal pain and nausea scores under 2 (none or minimal)
Measured: 2 hours
Treatment Success
both abdominal pain and nausea scores under 2 (none or minimal)
Measured: 24 hours
Treatment Success
both abdominal pain and nausea scores under 2 (none or minimal)
Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Aug 202120 Nov 2023

First posted4 Oct 2021
Study start30 Aug 2021
Primary completion20 Nov 2023
Study completion20 Nov 2023

Why it stopped: Lost too many patients to follow up, unable to enroll enough patients

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cyclic Vomiting SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 32 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05065567
Sponsor's protocol ID: EGME#02-2021
Status last verified: May 2025
First submitted: 23 Sep 2021
Last updated: 21 May 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Recruiting
Cortical Excitability in Cyclic Vomiting Syndrome
Cyclic Vomiting Syndrome
Recruiting
A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome
Cyclic Vomiting Syndrome
Recruiting
Autonomic Reactivity and Personalized Neurostimulation
Functional Gastrointestinal Disorders (FGIDs), Cyclic Vomiting Syndrome
RecruitingObservational study
Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.
Functional Gastrointestinal Disorders, Gastroesophageal Reflux

All Cyclic Vomiting Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Comparison of Haloperidol 5mg IM vs Droperidol 2.5mg and Ondansetron for the Treatment of Hyperemesis in Cannabis Hyperemesis Syndrome
ClinicalTrials.gov ID: NCT05065567
Acronym / sponsor ID: EGME#02-2021
Conditions: Cyclic Vomiting Syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Lost too many patients to follow up, unable to enroll enough patients
Enrolment: 32 participants (actual)
Lead sponsor: Corewell Health SouthUniversity, hospital or other
Study start: 30 Aug 2021 (actual)
Primary completion: 20 Nov 2023 (actual)
Study completion: 20 Nov 2023 (actual)
First posted: 4 Oct 2021 (actual)
Results: Posted 21 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 3

Arm	Type	Receives
haloperidol	Active comparator	Drug: Haloperidolthese patients will receive 5mg IM haloperidol
droperidol	Active comparator	Drug: Droperidolthese patients will receive 2.5mg IV droperidol
ondansetron	Active comparator	Drug: Ondansetron 8mgthese patients will receive 8mg IV ondansetron

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

adult patients with clinical diagnosis of cyclic vomiting in the ED

Key exclusion criteria (1 listed)

pregnancy, allergy to any of the study medicines

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DroperidolPatients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 2.5mg droperidol IV	Drug	droperidol
HaloperidolPatients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to 5mg haloperidol IM	Drug	haloperidol
Ondansetron 8mgPatients with suspected cannabis hyperemesis syndrome and enrolled in the study will be randomized based on the week to ondansetron	Drug	ondansetron

Primary outcome

Abdominal Pain
Time frame: 2 hours
change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale
Nausea
Time frame: 2 hours
change in nausea on 0 (none) through 10 (worse possible nausea) on a scale
Abdominal Pain
Time frame: 24 hours
change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale
Nausea
Time frame: 24 hours
change in nausea on 0 (none) through 10 (worse possible nausea) on a scale
Abdominal Pain
Time frame: 48 hours
change in abdominal pain on 0 (no pain) through 10 (worse possible pain) on a visual analog scale
Nausea
Time frame: 48 hours
change in nausea on 0 (none) through 10 (worse possible nausea) on a scale

3 secondary outcomes

Treatment Success
Time frame: 2 hours
Treatment Success
Time frame: 24 hours
Treatment Success
Time frame: 48 hours

Results and safety

Results posted to the registry on 21 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Haloperidol	11	1
Droperidol	14	5
Ondansetron	7	1

Primary outcome: Abdominal Pain

Time frame: 2 hours. Mean (Standard Deviation). Unit: score on a scale

Measure	Haloperidol n = 10	Droperidol n = 13	Ondansetron n = 5
Value	4.00 (3.30)	3.38 (3.04)	4.8 (3.70)

Primary outcome: Nausea

Time frame: 2 hours. Mean (Standard Deviation). Unit: score on a scale

Measure	Haloperidol n = 10	Droperidol n = 13	Ondansetron n = 6
Value	3.40 (3.37)	3.69 (2.50)	5 (4.10)

Primary outcome: Abdominal Pain

Time frame: 24 hours. Mean (Standard Deviation). Unit: score on a scale

Measure	Haloperidol n = 1	Droperidol n = 5	Ondansetron n = 1
Value	5 (NA)	2.6 (3.71)	3 (NA)

Primary outcome: Nausea

Time frame: 24 hours. Mean (Standard Deviation). Unit: score on a scale

Measure	Haloperidol n = 1	Droperidol n = 5	Ondansetron n = 1
Value	3.0 (NA)	3.0 (3.67)	7.0 (NA)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 48 hours from drug administration.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Haloperidol	0 of 11 (0%)	0 of 11 (0%)	0 of 11
Droperidol	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Ondansetron	0 of 7 (0%)	0 of 7 (0%)	0 of 7

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

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes

Related trials for Cyclic Vomiting Syndrome

Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Recruiting
Cortical Excitability in Cyclic Vomiting Syndrome
Cyclic Vomiting Syndrome
Recruiting
A Study of Auricular Neurostimulation for Children With Cyclic Vomiting Syndrome
Cyclic Vomiting Syndrome
Recruiting
Autonomic Reactivity and Personalized Neurostimulation
Functional Gastrointestinal Disorders (FGIDs), Cyclic Vomiting Syndrome
RecruitingObservational study
Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.
Functional Gastrointestinal Disorders, Gastroesophageal Reflux

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Droperidol, Haloperidol and Ondansetron 8mg in people with Cyclic Vomiting Syndrome, run by Corewell Health South at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Abdominal Pain (time frame: 2 hours). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05065567.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.