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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: Completed Phase 2 study, sponsored by Women and Infants Hospital of Rhode Island.
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, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Time to perceived symptom control as measured by time elapsed between metoclopramide administration and patient request for discharge.
Interventions
- DRUG Ondansetron
- DRUG Metoclopramide
- DRUG Lactated Ringers, Intravenous
- DRUG Capsaicin Topical Cream
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2022-05-24 |
| Est. Completion | 2023-03-01 |
| Phase | Phase 2 |
What the finished NCT05098067 record still lists
NCT05098067 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (77% lower).
The record links to 0 conditions, and to 4 interventions - of which Ondansetron is the first listed.
NCT05098067 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05098067's enrollment target sits among peer trials
30 1582nd of 2000 higher than 332 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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