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NCT05098067 · ClinicalTrials.gov registry record · Phase 2

Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy

A Phase 2 study, sponsored by Women and Infants Hospital of Rhode Island.

Completed
Registry status
Phase 2
Development phase
30
Enrollment target

NCT05098067 is a Phase 2 study that has completed, run by Women and Infants Hospital of Rhode Island. The registered enrollment target is 30 participants.

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The verdict

NCT05098067, a Phase 2 study, has completed, sponsored by Women and Infants Hospital of Rhode Island.

COMPLETED
Registry status
Phase 2
Development phase
30 participants
Enrollment target

Study 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.

Interventions

  • DRUG Ondansetron
  • DRUG Metoclopramide
  • DRUG Lactated Ringers, Intravenous
  • DRUG Capsaicin Topical Cream

Trial Details

FieldValue
Enrollment Target 30 participants
Start Date 2022-05-24
Est. Completion 2023-03-01
Phase Phase 2

What the Registry Record Tells You About NCT05098067

The ClinicalTrials.gov registry entry for NCT05098067 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Women and Infants Hospital of Rhode Island, which has 65 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 4 interventions - of which Ondansetron is the first listed.

NCT05098067 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05098067 about?

NCT05098067 is a clinical study titled "Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy". 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 ke...

What is the current status of trial NCT05098067?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 30 participants. The study started on 2022-05-24. Estimated completion is 2023-03-01.

What interventions are being tested in trial NCT05098067?

The interventions under investigation include: Ondansetron (DRUG), Metoclopramide (DRUG), Lactated Ringers, Intravenous (DRUG), Capsaicin Topical Cream (DRUG).

Who is sponsoring clinical trial NCT05098067?

This trial is sponsored by Women and Infants Hospital of Rhode Island, which has 65 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.