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Recruiting NCT07337902

Comparing Over the Counter Pain Medicines for Discomfort in Crohn's Disease (AVID-CD)

Conditions: Crohn's Disease (CD), Dysmenorrhea Primary

Sex: Female
Ages: 18 Years – 44 Years
Healthy volunteers: No
Phase: NA
Enrollment: 24
Sponsor: University of North Carolina, Chapel Hill

Location: University of North Carolina at Chapel Hill Chapel Hill North Carolina

Summary

The purpose of this pilot study is to prepare for a larger study that will compare the effectiveness and safety of two common pain medications, ibuprofen and acetaminophen, to help treat period cramps in women with Crohn's disease. The goal of this study is to identify any challenges in running a larger study. The investigators will track how many people sign up for the study, how well participants follow the study plan, how many people stay in the study, and whether they are able to complete all the study activities, such as taking the medication, submitting samples, and filling out surveys. During the study, participants will undergo a screening visit that includes a blood draw, physical exam, pregnancy test, stool testing, and complete surveys about Crohn's disease and menstrual cycles. Once this visit is complete, the rest of the study will occur at home. Participants will be assigned to take either ibuprofen or acetaminophen to help treat period cramps for four menstrual cycles in a row. Participants will take ibuprofen for two cycles and acetaminophen for two cycles. Participants will know which medication is being taken at any given time, but the order in which they take the medications will be randomly assigned. Before each menstrual cycle, participants will submit a stool sample and fill out a short (\

Eligibility Criteria

Inclusion Criteria: * Ages 18-44 years * Assigned female at birth * Crohn's Disease (CD) diagnosis * In stable clinical remission from CD, defined as a short Crohn's Disease Activity Index (CDAI; See Table 3) \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07337902). StuddyBuddy aggregates publicly available trial information.