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

NCT05098067 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: 1763191-1
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperemesis Gravidarum; Nausea Gravidarum; Vomiting of Pregnancy

Keywords

capsaicin; nausea; vomiting; pregnancy; hyperemesis gravidarum

Outcome Measures

Primary Outcomes (1)

• Time to Symptom Control

  Time to perceived symptom control as measured by time elapsed between metoclopramide administration and patient request for discharge.

  180 minutes

Secondary Outcomes (1)

• Number of Antiemetics Needed for Symptom Control

  180 minutes

Study Arms (2)

Intervention group

EXPERIMENTAL

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.

Drug: Capsaicin Topical Cream; Drug: Metoclopramide; Drug: Ondansetron; Drug: Lactated Ringers, Intravenous

Placebo group

PLACEBO COMPARATOR

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.

Drug: Metoclopramide; Drug: Ondansetron; Drug: Lactated Ringers, Intravenous

Interventions

Capsaicin Topical Cream DRUG

5g 0.075% applied once

Intervention group

Metoclopramide DRUG

10mg IV once

Also known as: Reglan

Intervention group; Placebo group

Ondansetron DRUG

8mg IV once if needed

Also known as: Zofran

Intervention group; Placebo group

Lactated Ringers, Intravenous DRUG

1000cc once

Intervention group; Placebo group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Women and Infants Hospital of Rhode Island: lead

Study Sites (1)

Women and Infants Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (9)

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  PMID: 1201188 BACKGROUND

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  PMID: 23913638 BACKGROUND

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  PMID: 12100809 BACKGROUND

• Richards JR, Lapoint JM, Burillo-Putze G. Cannabinoid hyperemesis syndrome: potential mechanisms for the benefit of capsaicin and hot water hydrotherapy in treatment. Clin Toxicol (Phila). 2018 Jan;56(1):15-24. doi: 10.1080/15563650.2017.1349910. Epub 2017 Jul 21.

  PMID: 28730896 BACKGROUND

• Dean DJ, Sabagha N, Rose K, Weiss A, France J, Asmar T, Rammal JA, Beyer M, Bussa R, Ross J, Chaudhry K, Smoot T, Wilson K, Miller J. A Pilot Trial of Topical Capsaicin Cream for Treatment of Cannabinoid Hyperemesis Syndrome. Acad Emerg Med. 2020 Nov;27(11):1166-1172. doi: 10.1111/acem.14062. Epub 2020 Jul 20.

  PMID: 32569429 BACKGROUND

• Yuan LJ, Qin Y, Wang L, Zeng Y, Chang H, Wang J, Wang B, Wan J, Chen SH, Zhang QY, Zhu JD, Zhou Y, Mi MT. Capsaicin-containing chili improved postprandial hyperglycemia, hyperinsulinemia, and fasting lipid disorders in women with gestational diabetes mellitus and lowered the incidence of large-for-gestational-age newborns. Clin Nutr. 2016 Apr;35(2):388-393. doi: 10.1016/j.clnu.2015.02.011. Epub 2015 Mar 2.

  PMID: 25771490 BACKGROUND

• Yosipovitch G, Mengesha Y, Facliaru D, David M. Topical capsaicin for the treatment of acute lipodermatosclerosis and lobular panniculitis. J Dermatolog Treat. 2005 Aug;16(3):178-80. doi: 10.1080/09546630510041079.

  PMID: 16096187 BACKGROUND

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  PMID: 10757584 BACKGROUND

• Murphy LM, Whelan AR, Griffin LB, Hamel MS. A pilot randomized control trial of topical capsaicin as adjunctive therapy for nausea and vomiting of pregnancy. Am J Obstet Gynecol MFM. 2023 Jul;5(7):100997. doi: 10.1016/j.ajogmf.2023.100997. Epub 2023 Jun 2.

  PMID: 37271593 DERIVED

MeSH Terms

Conditions

Hyperemesis Gravidarum; Nausea; Vomiting

Interventions

Metoclopramide; Ondansetron; Ringer's Lactate

Condition Hierarchy (Ancestors)

Morning Sickness; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Dr. Lauren Murphy
• Organization: Women and Infants Hospital

lmmurphy@wihri.org

2107222589

Study Officials

• Lauren Murphy, MD

  Women and Infants Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2021
• First Posted: October 28, 2021
• Study Start: May 24, 2022
• Primary Completion: October 17, 2022
• Study Completion: March 1, 2023
• Last Updated: February 7, 2024
• Results First Posted: February 7, 2024

Record last verified: 2024-02

Locations

US (1)