Topical Analgesic

Capsaicin for Cannabinoid Hyperemesis Syndrome

UVA Health System, Charlottesville, VA

Capsaicin +1 morePhase 4Waitlist AvailableLed by Angela Holian, PharmDResearch Sponsored by University of Virginia

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 18 years old

Diagnosis of cannabinoid hyperemesis syndrome

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up30 days (outpatient phone call)

Awards & highlights

Drug Has Already Been Approved

All Individual Drugs Already Approved

Pivotal Trial

Study Summary

This trial will test if capsaicin cream can help people with a condition that causes them to vomit a lot.

Eligible Conditions

Cannabinoid Hyperemesis Syndrome

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 days (outpatient phone call)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 days (outpatient phone call)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days (outpatient phone call) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to resolution of symptoms

Secondary outcome measures

Clinical improvement in pain score

Other outcome measures

Symptom improvement at thirty days

Side effects data

From 2018 Phase 4 trial • 80 Patients • NCT02288156

31%

nasopharyngitis

19%

Nasal congestion

13%

Rhinorrhoea

13%

Cough

Rhinitis

Influenza

Sneezing

Cystitis

Laryngitis

Pyrexia

pain in extremity

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

0,01mM

0,1mM

0.001mM

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: CapsaicinExperimental Treatment1 Intervention

capsaicin 0.075% cream applied once topically

Group II: PlaceboActive Control1 Intervention

placebo cream applied once topically

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Capsaicin

FDA approved

0 / 2Eligibility criteria met

Find a site

Who is running the clinical trial?

University of VirginiaLead Sponsor

721 Previous Clinical Trials

1,567,472 Total Patients Enrolled

Angela Holian, PharmDPrincipal Investigator - University of Virginia

University of Virginia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals are participating in this therapeutic trial?

"Affirmative. According to the details hosted on clinicaltrials.gov, this trial began recruiting on December 1st 2020 and is still actively looking for participants. The study needs 50 individuals from one location to complete it."

Answered by AI

Is recruitment still ongoing for this research endeavor?

"Affirmative. According to records available on clinicaltrials.gov, the trial was initially posted on December 1st 2020 and is currently open for enrollment. This study needs 50 participants from a single location."

Answered by AI