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NCT01668069 · ClinicalTrials.gov registry record · NA
Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of Pregnancy
A NA study, sponsored by United States Naval Medical Center, San Diego.
- Completed
- Registry status
- NA
- Development phase
- 36
- Enrollment target
NCT01668069: Completed NA study, sponsored by United States Naval Medical Center, San Diego.
NCT01668069 is a NA study that has completed, run by United States Naval Medical Center, San Diego. The registered enrollment target is 36 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01668069, a NA study, has completed, sponsored by United States Naval Medical Center, San Diego.
- COMPLETED
- Registry status
- NA
- Development phase
- 36 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Ondansetron
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2012-10 |
| Est. Completion | 2013-04 |
| Phase | NA |
What the finished NCT01668069 record still lists
NCT01668069 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Ondansetron is the first listed.
NCT01668069 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01668069 about?
NCT01668069 is a clinical study titled "Ondansetron VS Doxylamine and Pyridoxine in Treating Nausea of 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)...
What is the current status of trial NCT01668069?
This trial is currently completed. It is a NA study. The enrollment target is 36 participants. The study started on 2012-10. Estimated completion is 2013-04.
What interventions are being tested in trial NCT01668069?
The interventions under investigation include: Ondansetron (DRUG).
Who is sponsoring clinical trial NCT01668069?
This trial is sponsored by United States Naval Medical Center, San Diego, which has 41 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01668069's enrollment target sits among peer trials
36 1541st of 2000 higher than 437 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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