CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
Capsaicin Topical Cream +3 moredrug
Likely dose
Capsaicin Topical Cream 5gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05098067
NCT05098067Phase 2Completed

Trial of Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy: A Pilot Investigation

Women and Infants Hospital of Rhode Island·interventional·Posted Oct 28, 2021·Updated Feb 7, 2024

In Brief

A Phase 2 clinical trial evaluating Capsaicin Topical Cream, Metoclopramide, and 2 other interventions for Hyperemesis Gravidarum and 2 related conditions. Completed, enrolled 30 participants across 1 site.

Detailed Summary

Between fifty and eighty percent of pregnant women experience nausea and vomiting in pregnancy making it one of the most common medical complications of pregnancy. Hyperemesis gravidarum is an extreme form of nausea and vomiting of pregnancy and results in evidence of acute starvation (i.e. large ketonuria), and weight loss (\>5% of a woman's pre-pregnancy weight). Hyperemesis gravidarum is also surprisingly common. In fact, it is the second leading cause of preterm hospitalization during pregnancy, second only preterm labor. Hospitalization is often required because hyperemesis is frequently refractory to common anti-nausea medications. However, capsaicin cream, a potent TRPV1 agonist, commonly used to relieve muscular and neuropathic pain, may be able to reduce the symptoms of nausea and emesis in patients with nausea and vomiting of pregnancy. Smaller studies have demonstrated capsaicin to be both safe and effective when used to treat intraoperative nausea during cesarean delivery. To begin to address whether capsaicin cream could be used to reduce preterm admissions and shorten emergency room visits for hyperemesis, this study will randomize women presenting to the emergency room for nausea and vomiting to treatment with capsaicin cream as an adjunctive medication or routine care. The project will investigate the impact of capsaicin cream on hospital length of stay as well as representation for additional treatment. If effective, capsaicin cream has the potential not only to reduce emergency room visits, hospital admissions and overall health care costs, but also to drastically improve patient quality of life.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedOct 28, 2021
Enrollment StartMay 24, 2022
Primary CompletionOct 17, 2022
Study CompletionMar 1, 2023
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 4.7 years ago

Interventions

Capsaicin Topical Creamdrug

5g 0.075% applied once

Metoclopramidedrug

10mg IV once

Ondansetrondrug

8mg IV once if needed

Lactated Ringers, Intravenousdrug

1000cc once