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

Primary Purpose

Hyperemesis Gravidarum, Nausea Gravidarum, Vomiting of Pregnancy

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Capsaicin Topical Cream
Metoclopramide
Ondansetron
Lactated Ringers, Intravenous
Sponsored by
Women and Infants Hospital of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperemesis Gravidarum focused on measuring capsaicin, nausea, vomiting, pregnancy, hyperemesis gravidarum

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Pregnant women in the first trimester (0-14 weeks gestation)
  • Presenting to the emergency room at Women & Infants Hospital in Rhode Island with a chief complaint of nausea and vomiting
  • English or Spanish speaking
  • Have not taken an anti-emetic such as Reglan or Zofran within the 6 hours prior to presentation

Exclusion Criteria:

  • Allergy to Reglan, capsaicin or Zofran
  • Another identifiable source for nausea and vomiting (i.e. gastritis, COVID, diabetic ketoacidosis)
  • Molar pregnancies,
  • Patients with a history of gastroparesis
  • Patients with a history of preexisting diabetes mellitus

Sites / Locations

  • Women and Infants HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention group

Placebo group

Arm Description

Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of 0.075% capsaicin cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS)11,12. The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered.

Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of placebo cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS). The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered.

Outcomes

Primary Outcome Measures

Time to symptom control
Time to perceived symptom control as measured by a validated scale used to measure patient's perception of the severity of nausea and vomiting symptoms (i.e. VAS)

Secondary Outcome Measures

Number of antiemetics needed for symptom control
Length of emergency department stay
Time to discharge from the emergency department

Full Information

First Posted
October 20, 2021
Last Updated
October 17, 2022
Sponsor
Women and Infants Hospital of Rhode Island
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1. Study Identification

Unique Protocol Identification Number
NCT05098067
Brief Title
Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy
Official Title
Trial of Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy: A Pilot Investigation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 24, 2022 (Actual)
Primary Completion Date
October 17, 2022 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Women and Infants Hospital of Rhode Island

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperemesis Gravidarum, Nausea Gravidarum, Vomiting of Pregnancy
Keywords
capsaicin, nausea, vomiting, pregnancy, hyperemesis gravidarum

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of 0.075% capsaicin cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS)11,12. The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered.
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Participants will receive IV fluid bolus of 1000cc of lactated ringers, metoclopromide 10mg IV and will have 5g of placebo cream applied to their abdomen. Participants will indicate the severity of their symptoms immediately prior to administration of metoclopromide, at time 0 and every 30 minutes for a total of 120 minutes after administration of the first medications (or discharge) using a 10 cm visual analogue scale (VAS). The scale will be provided in English or Spanish as appropriate. If at the 90-minute time mark the patient does not report improvement of their symptoms, odansetron 8mg IV will be administered.
Intervention Type
Drug
Intervention Name(s)
Capsaicin Topical Cream
Intervention Description
5g 0.075% applied once
Intervention Type
Drug
Intervention Name(s)
Metoclopramide
Other Intervention Name(s)
Reglan
Intervention Description
10mg IV once
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
8mg IV once if needed
Intervention Type
Drug
Intervention Name(s)
Lactated Ringers, Intravenous
Intervention Description
1000cc once
Primary Outcome Measure Information:
Title
Time to symptom control
Description
Time to perceived symptom control as measured by a validated scale used to measure patient's perception of the severity of nausea and vomiting symptoms (i.e. VAS)
Time Frame
180 minutes
Secondary Outcome Measure Information:
Title
Number of antiemetics needed for symptom control
Time Frame
180 minutes
Title
Length of emergency department stay
Description
Time to discharge from the emergency department
Time Frame
180 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Pregnant women in the first trimester (0-14 weeks gestation) Presenting to the emergency room at Women & Infants Hospital in Rhode Island with a chief complaint of nausea and vomiting English or Spanish speaking Have not taken an anti-emetic such as Reglan or Zofran within the 6 hours prior to presentation Exclusion Criteria: Allergy to Reglan, capsaicin or Zofran Another identifiable source for nausea and vomiting (i.e. gastritis, COVID, diabetic ketoacidosis) Molar pregnancies, Patients with a history of gastroparesis Patients with a history of preexisting diabetes mellitus
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lauren Murphy, MD
Phone
210-722-2589
Email
lmmurphy@wihri.org
First Name & Middle Initial & Last Name or Official Title & Degree
Maureen Hamel, MD
Phone
508-479-9190
Email
mhamel@kentri.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lauren Murphy, MD
Organizational Affiliation
Women and Infants Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Women and Infants Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maureen Hamel, MD
First Name & Middle Initial & Last Name & Degree
Lauren Murphy, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
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1201188
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Results Reference
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Citation
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Capsaicin Cream as an Adjunctive Therapy for Nausea and Vomiting of Pregnancy

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