Actively Recruiting
Acetaminophen Versus Ibuprofen for Discomfort in Crohn's Disease (AVID-CD): An Open-Label Randomized Pilot Trial
Led by University of North Carolina, Chapel Hill · Updated on 2026-03-23
24
Participants Needed
1
Research Sites
N/A
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
Researchers are studying women with Crohn's disease who experience period cramps to compare how two common pain medications, ibuprofen and acetaminophen, work and are tolerated. This pilot study aims to identify challenges in running a larger study by tracking participant interest, adherence, retention, and completion of study activities such as medication use, sample submissions, and surveys. Participants will take both ibuprofen and acetaminophen during four menstrual cycles, with two cycles for each medication. The order of medication use is randomly assigned, and participants will know which medication they are taking. Before each cycle, participants submit stool samples and complete short electronic surveys. When cramps start, they take the assigned medication three times daily for three days and fill out brief surveys about their cramps. After medication use, more stool samples and surveys are completed. After four cycles, participants join a remote interview to provide feedback. Throughout the study, participants complete a screening visit involving blood tests, physical exam, pregnancy test, stool testing, and surveys about Crohn's disease and menstrual cycles. Most study activities occur at home via electronic surveys and sample collection. Researchers measure participant interest, enrollment, adherence, and ability to complete study tasks. Safety and study acceptability are also assessed. The study runs from March 2026 to July 2028.
CONDITIONS
Brief 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 to 44 years
- Assigned female at birth
- Diagnosed with Crohn's Disease
- In stable clinical remission from Crohn's Disease without corticosteroids
- Self-reported primary dysmenorrhea (painful periods)
- Regular menstrual cycles every 23 to 35 days
- Using effective contraception or abstinent
You will not qualify if you...
- Conditions such as endometriosis, adenomyosis, polycystic ovarian syndrome, endometrial fibroids or polyps, chronic pelvic inflammatory disease, or history of pelvic surgery including hysterectomy
- Current pregnancy or plans to become pregnant during the study
- Unstable or recent changes in oral contraceptive use within the last 3 months
- Taking hormone therapy not part of contraception
- Known allergy or contraindication to ibuprofen or acetaminophen
- Unable to complete electronic surveys or lack access to smartphone/computer
- Unable to read and speak English
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 5 months
Participants receive oral acetaminophen or ibuprofen for three days during two of four menstrual cycles, according to their assigned sequence, to manage discomfort related to dysmenorrhea.
4 treatment periods corresponding to menstrual cycles
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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