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Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy

This study is currently recruiting participants.
Verified August 2012 by United States Naval Medical Center, San Diego
Sponsor:
Information provided by (Responsible Party):
United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT01668069
First received: August 15, 2012
Last updated: NA
Last verified: August 2012
History: No changes posted
  Purpose

Our purpose is to determine whether ondansetron, a commonly used antiemetic, is equivalent in efficacy to the combination of pyridoxine and doxylamine, the currently recommended first line therapy for nausea and vomiting in pregnancy by the American Congress of Obstetricians and Gynecologists (ACOG). Since both treatments are safe in pregnancy, many physicians are using ondansetron as first line in practice. Despite this practice and the recommendations from ACOG, there is not data to suggest that ether practice is superior. This will be the first prospective, randomized, double blind, controlled trial comparing the two treatments. We hypothesize that ondansetron will be equally efficacious in reducing nausea and episodes of emesis. By alleviating nausea and vomiting associated with pregnancy, patients will likely benefit from less Emergency Department visits, urgent clinic visits, and admissions for progression to hyperemesis gravidarum.


Condition Intervention
Vomiting of Pregnancy
 Drug: Ondansetron
Drug: Doxylamine and pyridoxine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Is Zofran Superior to Pyridoxine at Reducing Nausea and Vomiting in Pregnancy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by United States Naval Medical Center, San Diego:

Primary Outcome Measures:
  • Reduction of nausea on the VAS (Visual Analog Scale) [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Reduction in vomiting on the VAS [ Time Frame: 5 days ] [ Designated as safety issue: No ]
  • Any adverse effects caused by the study medications. [ Time Frame: 5 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: April 2012
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ondansetron Drug: Ondansetron
Ondansetron 4mg and a placebo capsule to be taken orally every 8 hours for 5 days.
Other Name: Zofran
Experimental: Doxylamine and Pyridoxine (vitamin B6) Drug: Doxylamine and pyridoxine
Pyridoxine 25mg and doxylamine 12.5mg to be taken orally every 8 hours for 5 days.
Other Name: Vitamin B6

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women who are less than 16 weeks pregnant by last menstrual period or ultrasound
  • Greater than 18 years of age
  • English speaking
  • No significant visual or hearing impairment
  • Requesting treatment for nausea associated with pregnancy

Exclusion Criteria:

  • If nausea or vomiting preexisted the pregnancy
  • Requires hospitalization at the time of initial enrollment
  • Already taking anti-emetics to include metoclopramide, ondansetron, doxylamine, pyridoxine, or promethazine
  • The patient has an allergy to either study regimen
  • If they are unable to return for a follow up visit in 1 week
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01668069

Contacts
Contact: Lauren G Oliveira, DO 619 9615715 Lauren.G.Oliveira@gmail.com

Locations
United States, California
Naval Medical Center, San Diego Recruiting
San Diego, California, United States, 92134
Sponsors and Collaborators
United States Naval Medical Center, San Diego
Investigators
Principal Investigator: Lauren G Oliveira, DO United States Naval Medical Center, San Diego
  More Information

No publications provided

Responsible Party: United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier: NCT01668069     History of Changes
Other Study ID Numbers: NMCSD-2011-0151
Study First Received: August 15, 2012
Last Updated: August 15, 2012
Health Authority: United States: Federal Government

Keywords provided by United States Naval Medical Center, San Diego:
nausea
vomiting
pregnancy
ondansetron
 doxylamine
vitamin B6
pyridoxine

Additional relevant MeSH terms:
Nausea
Vomiting
Pregnancy Complications
Signs and Symptoms, Digestive
Signs and Symptoms
Doxylamine
Doxylamine succinate
Ondansetron
Pyridoxine
Vitamin B 6
Pyridoxal
Vitamin B Complex
Vitamins
Histamine H1 Antagonists
Histamine Antagonists
 Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Micronutrients
Growth Substances
Antipruritics
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013