← Back to Search

Cimetidine Excretion During Lactation

Phase 4
Recruiting
Led By Mary Hebert, PharmD, FCCP
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3-5 weeks, 3-4 months and 6-8 months postpartum
Awards & highlights

Study Summary

This trial studies the effect of pregnancy on drug absorption and expression in breast tissue.

Who is the study for?
This trial is for healthy, lactating or pregnant women planning to breastfeed, aged 18-50, and their nursing infants between 3 weeks to 8 months old. Participants must not be on medications that could interact with the study drug.Check my eligibility
What is being tested?
The study is testing how Cimetidine (200 MG), a medication commonly used to treat heartburn and stomach ulcers, is excreted in breast milk at different times after childbirth.See study design
What are the potential side effects?
Cimetidine can cause side effects like headache, dizziness, diarrhea or constipation. It may also lead to tiredness or muscle pain. Rarely it might cause confusion or an irregular heartbeat.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3-5 weeks, 3-4 months and 6-8 months postpartum
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-5 weeks, 3-4 months and 6-8 months postpartum for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mammary clearance of cimetidine
Mammary epithelial cell expression of BCRP
Mammary epithelial cell expression of OCT1
Secondary outcome measures
Cimetidine relative infant dose and infant concentration
Maternal cimetidine PK
Relationship between BCRP expression and activity
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Healthy Lactating WomenExperimental Treatment1 Intervention
Healthy Lactating Women will be studied on 3 study days and serve as their own control.

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,741 Previous Clinical Trials
1,847,716 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,747 Total Patients Enrolled
Mary Hebert, PharmD, FCCPPrincipal InvestigatorUniversity of Washington

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research open to geriatric patients?

"This trial has set 18 years as the minimum age for entry and 50 years as the upper limit."

Answered by AI

Am I qualified to partake in this research?

"Eligibility to participate in this medical trial is limited to patients who are lactating and aged between 18-50 years old. The research team has set out to recruit 50 individuals as part of the study."

Answered by AI

Is this trial currently accessible to participants?

"According to clinicaltrials.gov, this research project is actively seeking out participants. The listing was first posted on October 1st 2023 and updated for the final time on September 20th of that same year."

Answered by AI

What potential risks exist when administering medication to lactating women?

"Healthy lactating women are considered safe to use this treatment, so it garnered a score of 3. The approval was given because the Phase 4 trial demonstrated that this medication is suitable for these individuals."

Answered by AI

What is the ceiling for patient enrollment in this trial?

"Affirmative. According to records on clinicaltrials.gov, this medical trial is actively seeking participants as of September 20th, 20203. This research was initially made public on October 1st and requires 50 volunteers across a single site."

Answered by AI

For what purpose is this research endeavor being conducted?

"The primary goal of this trial, assessed at 3-5 weeks postpartum, 3-4 months postpartum and 6-8 months postpartum is to examine Mammary Epithelial Cell expression levels of BCRP. Secondary goals include evaluating the Relationship between OCT1 expression and activity (as defined by Effect of time postpartum on OCT1 protein expression in MECs and correlation with cimetidine mammary CL), assessing Maternal Cimetidine PK (or Effects of time postpartum on cimetidine elimination rate constant) as well as examining the Relationship between BCRP expression and activity (defined by"

Answered by AI
~33 spots leftby Sep 2028