Who is eligible for clinical trial NCT07337902?

Participants must meet the protocol's inclusion criteria for Crohn's Disease (CD). The stated age range is 18 Years to 44 Years. Confirm all requirements with the study coordinator.

Does clinical trial NCT07337902 provide travel or cost reimbursement?

Check with the site coordinator at the participating facility for travel and lodging stipend availability, and for which routine-care costs are covered.

🏛️ Verified NIH Record • Updated 2026-07-10

Comparing Over the Counter Pain Medicines for Discomfort in Crohn's Disease (AVID-CD) (NCT07337902)

Acetaminophen Versus Ibuprofen for Discomfort in Crohn's Disease (AVID-CD): An Open-Label Randomized Pilot Trial

🟢 Recruiting Observational / Diagnostic 📋 Clinical Research Protocol Sponsor: University of North Carolina, Chapel Hill

🩺 Plain-English Summary (8th-Grade Level)

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.

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (7 items) and avoid the listed exclusions (8 items).

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

Age range: 18 Years to 44 Years

🧪 Interventions in This Study

Acetaminophen (OTHER)
Ibuprofen (OTHER)

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

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) \<150 without use of corticosteroids
Self-reported primary dysmenorrhea
Regular menstrual cycles occurring every 23-35 days
Using an appropriate contraceptive method or abstinence

Usually NOT eligible if any of the following apply:

Exclusion Criteria:
Any of the following conditions: endometriosis, adenomyosis, polycystic ovarian syndrome, endometrial fibroids/polyps, chronic pelvic inflammatory disease, a history of pelvic surgery including hysterectomy, any other pathological pelvic conditions, or current pregnancy
Plans to become pregnant during the study period
Use of an oral contraceptive for less than 3 months, on an unstable oral contraceptive dose within the last 3 months, switched from one oral contraceptive to another within the last 3 months or intend to do so during the course of the trial
Taking hormone therapy including estrogen or progesterone that is not part of a hormonal contraceptive
Known hypersensitivity or contraindication to ibuprofen or acetaminophen
Inability to complete REDCap questionnaires (including confusion despite training and/or lack of smart phone and/or computer access).
Not able to speak and read English language.

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (1 Sites)

University of North Carolina at Chapel Hill — Chapel Hill, North Carolina

📞 Contact the Study Coordinator

Phone: (919) 964-2141

Email: rachel_cooke@med.unc.edu

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

💰 Cost, Insurance & Patient Rights

100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

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💡 How to Participate

Check the checklist above to see if you may qualify.
Contact the study coordinator using the phone/email above.
Ask about the visit schedule, what is covered at no cost, and any travel support.
Confirm with your own doctor before making a decision.

🏛️ View Official NIH Record ↗