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This is a phase 2 randomized controlled trial testing the effect of topical capsaicin for the relieve of nausea and vomiting.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Capsaicin | Experimental | 0.1% capsaicin cream, one application |
|
| Placebo | Placebo Comparator | Topical cream with no active drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsaicin 0.1% Cream | Drug | Topical application |
| |
| Placebos |
| Measure | Description | Time Frame |
|---|---|---|
| Nausea Visual Analog Scale | Nausea visual analog scale, ranging from 0-100 mm, high measurement indicates worse nausea | 30 minutes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Miller, MD | Henry Ford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henry Ford Hospital | Detroit | Michigan | 48202 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Capsaicin | 0.1% capsaicin cream, one application Capsaicin 0.1% Cream: Topical application |
| FG001 | Placebo | Topical cream with no active drug Placebos: placebo cream |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Capsaicin | 0.1% capsaicin cream, one application Capsaicin 0.1% Cream: Topical application |
| BG001 | Placebo | Topical cream with no active drug Placebos: placebo cream |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nausea Visual Analog Scale | Nausea visual analog scale, ranging from 0-100 mm, high measurement indicates worse nausea | Patients identified with cannabinoid hyperemesis | Posted | Mean | 95% Confidence Interval | mm | 30 minutes |
|
4 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Capsaicin | 0.1% capsaicin cream, one application Capsaicin 0.1% Cream: Topical application |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Skin irritation | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Joseph Miller, associate research director | Henry Ford Hospital | 313-916-5419 | jmiller6@hfhs.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 5, 2017 | Dec 14, 2021 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 1, 2019 | Dec 14, 2021 | SAP_003.pdf |
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| ID | Term |
|---|---|
| C536228 | Familial cyclic vomiting syndrome |
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| ID | Term |
|---|---|
| D002211 | Capsaicin |
| ID | Term |
|---|---|
| D053284 | Polyunsaturated Alkamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000475 | Alkenes |
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Identical appearing placebo cream used for control
| Drug |
placebo cream |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Nausea on visual analog scale | Minimum measurement 0, maximum 100. Higher score indicates more severe nausea. | Mean | Standard Deviation | mm |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 1 |
| 17 |
| EG001 | Placebo | Topical cream with no active drug Placebos: placebo cream | 0 | 13 | 0 | 13 | 0 | 13 |
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| D006839 |
| Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D005229 | Fatty Acids, Monounsaturated |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |