- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01668069
Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy
April 4, 2016 updated by: United States Naval Medical Center, San Diego
Is Zofran Superior to Pyridoxine at Reducing Nausea and Vomiting in Pregnancy
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.
Study Overview
Study Type
Interventional
Enrollment (Actual)
36
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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California
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San Diego, California, United States, 92134
- Naval Medical Center, San Diego
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 88 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Ondansetron
study drug
|
Ondansetron 4mg and a placebo capsule to be taken orally every 8 hours for 5 days.
Other Names:
|
No Intervention: Doxylamine and Pyridoxine (vitamin B6)
other nausea treatment in use
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of nausea on the VAS (Visual Analog Scale)
Time Frame: 5 days
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction in vomiting on the VAS
Time Frame: 5 days
|
5 days
|
Any adverse effects caused by the study medications.
Time Frame: 5 days
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Lauren G Oliveira, DO, United States Naval Medical Center, San Diego
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2012
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
April 1, 2013
Study Registration Dates
First Submitted
August 15, 2012
First Submitted That Met QC Criteria
August 15, 2012
First Posted (Estimate)
August 17, 2012
Study Record Updates
Last Update Posted (Estimate)
April 6, 2016
Last Update Submitted That Met QC Criteria
April 4, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Antiemetics
- Gastrointestinal Agents
- Dermatologic Agents
- Antipsychotic Agents
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Serotonin Antagonists
- Anti-Anxiety Agents
- Antipruritics
- Ondansetron
Other Study ID Numbers
- CIP#NMCSD.2011.0151
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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