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Proton Pump Inhibitor

Pantoprazole for Nausea and Vomiting

Phase 2
Recruiting
Research Sponsored by United States Naval Medical Center, Portsmouth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Undergoing elective gynecological surgery by either an open abdominal or minimally invasive approach (to include both endoscopic and vaginal). Procedure must be performed under general anesthesia.
Be older than 18 years old
Must not have
Patients with gastrointestinal disease requiring ongoing medical management
Known or suspected malignancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment until their postoperative visit at 6 weeks
Awards & highlights

Summary

This trial aims to find out if pantoprazole can help reduce nausea and vomiting after gynecologic surgery in women aged 18 to 79. Participants will be given either pantoprazole

Who is the study for?
This trial is for women aged 18-79 undergoing gynecologic surgery, aiming to see if pantoprazole can prevent postoperative nausea and vomiting. Specific eligibility criteria are not provided.
What is being tested?
The study tests whether pantoprazole, an acid reflux medication, is better than a placebo at preventing nausea and vomiting after surgery. Participants will take three pills around their operation time.
What are the potential side effects?
Potential side effects of pantoprazole may include headache, diarrhea, stomach pain, nausea or vomiting; however, specific side effects related to the trial are not listed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for gynecological surgery under general anesthesia.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am receiving treatment for a gastrointestinal condition.
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I have or might have cancer.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment until their postoperative visit at 6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment until their postoperative visit at 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Postoperative Nausea and Vomiting
Secondary outcome measures
Time to Oral Intake

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: ActiveActive Control1 Intervention
This arm receives the pantoprazole 40mg tablet. This medication is taken the night before, 2 hours before surgery, and the night after surgery.
Group II: PlaceboPlacebo Group1 Intervention
This arm receives the placebo drug. This medication is taken the night before, 2 hours before surgery, and the night after surgery.

Find a Location

Who is running the clinical trial?

United States Naval Medical Center, PortsmouthLead Sponsor
34 Previous Clinical Trials
4,723 Total Patients Enrolled
~10 spots leftby Dec 2024
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