Cyclical VomitingPhase 2NCT03223350
Topical Capsaicin for Cyclical Vomiting
A Phase 2 study testing Capsaicin 0.1% Cream in people with Cyclical Vomiting, run by Henry Ford Health System at 1 site in United States.
Trial summary
This is a phase 2 randomized controlled trial testing the effect of topical capsaicin for the relieve of nausea and vomiting. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cyclical Vomiting
- What is being tested?
- Capsaicin 0.1% Cream
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2017to 5 Aug 2019
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suspected cyclical vomiting syndrome / cannabinoid hyperemesis
- active severe nausea or vomiting in the emergency department
Who cannot join
- pregnant women, children < 18 years, no prior history of similar symptoms, suspected surgical or infectious cause of symptoms, suspected hepatitis or pancreatitis, allergy to capsaicin or hot peppers, chronic use of prescription antiemetic in prior 24 hours, abdominal pain alone (without nausea or vomiting)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Topical Capsaicin Cream for Treatment of Suspected Cyclical Vomiting Syndromes
This is a phase 2 randomized controlled trial testing the effect of topical capsaicin for the relieve of nausea and vomiting.
- Conditions
- Cyclical Vomiting
- Being tested
- Capsaicin 0.1% Cream, Placebos
- 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.
Capsaicin 0.1% CreamDrug
Topical application
PlacebosDrug
placebo cream
| Study group | Role | What they receive |
|---|---|---|
| Capsaicin | Experimental | 0.1% capsaicin cream, one application Receives: Drug: Capsaicin 0.1% Cream |
| Placebo | Placebo comparator | Topical cream with no active drug Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nausea Visual Analog Scale
Nausea visual analog scale, ranging from 0-100 mm, high measurement indicates worse nausea
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start20 Dec 2017
- Primary completion5 Aug 2019
- Study completion5 Aug 2019
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 Cyclical VomitingStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Miller, MD, Henry Ford Health System
- Investigators
- Joseph Miller, MD, Principal investigator, Henry Ford Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223350
- Sponsor's protocol ID
- 10658
- Status last verified
- Dec 2021
- First submitted
- 18 Jul 2017
- Last updated
- 15 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Capsaicin Cream for Treatment of Suspected Cyclical Vomiting Syndromes
- ClinicalTrials.gov ID
- NCT03223350
- Acronym / sponsor ID
- 10658
- Conditions
- Cyclical Vomiting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 5 Aug 2019 (actual)
- Study completion
- 5 Aug 2019 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Posted 15 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2 randomized controlled trial testing the effect of topical capsaicin for the relieve of nausea and vomiting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Capsaicin | Experimental | Drug: Capsaicin 0.1% Cream0.1% capsaicin cream, one application |
| Placebo | Placebo comparator | Drug: PlacebosTopical cream with no active drug |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- suspected cyclical vomiting syndrome / cannabinoid hyperemesis
- active severe nausea or vomiting in the emergency department
Key exclusion criteria (1 listed)
- pregnant women, children < 18 years, no prior history of similar symptoms, suspected surgical or infectious cause of symptoms, suspected hepatitis or pancreatitis, allergy to capsaicin or hot peppers, chronic use of prescription antiemetic in prior 24 hours, abdominal pain alone (without nausea or vomiting)
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 |
|---|---|---|
| Capsaicin 0.1% CreamTopical application | Drug | Capsaicin |
| Placebosplacebo cream | Drug | Placebo |
Primary outcome
Nausea Visual Analog Scale
Time frame: 30 minutes
Nausea visual analog scale, ranging from 0-100 mm, high measurement indicates worse nausea
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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RecruitingObservational study
Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.
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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.
Joseph Miller, MD principal investigator
Henry Ford Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Capsaicin 0.1% Cream in people with Cyclical Vomiting, run by Henry Ford Health System 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 2 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: finished, as of the sponsor's last update on 15 Dec 2021. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 15 Dec 2021). 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?
Nausea Visual Analog Scale (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2021; AzTrials last refreshed its copy on 27 Oct 2026.