Cyclical Vomiting
Conditions
Brief summary
This is a phase 2 randomized controlled trial testing the effect of topical capsaicin for the relieve of nausea and vomiting.
Interventions
Topical application
DRUGPlacebos
placebo cream
Sponsors
Henry Ford Health System
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Identical appearing placebo cream used for control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* suspected cyclical vomiting syndrome / cannabinoid hyperemesis * active severe nausea or vomiting in the emergency department
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nausea Visual Analog Scale | 30 minutes | Nausea visual analog scale, ranging from 0-100 mm, high measurement indicates worse nausea |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Capsaicin 0.1% capsaicin cream, one application
Capsaicin 0.1% Cream: Topical application | 17 |
| Placebo Topical cream with no active drug
Placebos: placebo cream | 13 |
| Total | 30 |
Baseline characteristics
| Characteristic | Capsaicin | Placebo | Total |
|---|---|---|---|
| Age, Continuous | 35.4 years STANDARD_DEVIATION 15.3 | 27.5 years STANDARD_DEVIATION 5.2 | 32.0 years STANDARD_DEVIATION 12.5 |
| Nausea on visual analog scale | 60 mm STANDARD_DEVIATION 29 | 85 mm STANDARD_DEVIATION 20 | 71 mm STANDARD_DEVIATION 28 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants | 12 Participants | 27 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 1 Participants | 2 Participants |
| Region of Enrollment United States | 17 participants | 13 participants | 30 participants |
| Sex: Female, Male Female | 10 Participants | 5 Participants | 15 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 13 |
| other Total, other adverse events | 1 / 17 | 0 / 13 |
| serious Total, serious adverse events | 0 / 17 | 0 / 13 |
Outcome results
Primary
Nausea Visual Analog Scale
Nausea visual analog scale, ranging from 0-100 mm, high measurement indicates worse nausea
Time frame: 30 minutes
Population: Patients identified with cannabinoid hyperemesis
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Capsaicin | Nausea Visual Analog Scale | 41 mm |
| Placebo | Nausea Visual Analog Scale | 61 mm |