Actively Recruiting
Comparing Over the Counter Pain Medicines for Discomfort in Crohn's Disease (AVID-CD)
Led by University of North Carolina, Chapel Hill · Updated on 2026-03-23
24
Participants Needed
1
Research Sites
119 weeks
Total Duration
On this page
Sponsors
U
University of North Carolina, Chapel Hill
Lead Sponsor
A
American College of Gastroenterology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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 (\<1 minute) electronic survey. When participants develop period cramps, they will take the assigned medication for three days and fill out short (\<1 minute) electronic surveys about their cramps. After participants finish taking the medication for three days, they will submit another stool sample and fill out two more short (\<1 minute) electronic surveys. After have completing this process for four menstrual cycles, a remote interview with a researcher to give feedback on the study will be conducted.
CONDITIONS
Official Title
Comparing Over the Counter Pain Medicines for Discomfort in Crohn's Disease (AVID-CD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18-44 years
- Assigned female at birth
- Diagnosed with Crohn's Disease
- Stable clinical remission from Crohn's Disease without corticosteroids
- Self-reported primary dysmenorrhea
- Regular menstrual cycles every 23-35 days
- Using appropriate contraception or abstinent
You will not qualify if you...
- Conditions including endometriosis, adenomyosis, polycystic ovarian syndrome, endometrial fibroids/polyps, chronic pelvic inflammatory disease, pelvic surgery history, other pelvic conditions, or current pregnancy
- Plans to become pregnant during the study
- Oral contraceptive use unstable or less than 3 months, or planned changes within the study
- Taking hormone therapy not part of contraception
- Known allergy or contraindication to ibuprofen or acetaminophen
- Inability to complete electronic questionnaires due to confusion or lack of device access
- Unable to read and speak English
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
4
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