Comparing Over the Counter Pain Medicines for Discomfort in Crohn's Disease (AVID-CD)
Not applicable · Testing Acetaminophen and Ibuprofen · 1 site · University of North Carolina, Chapel Hill
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Acetaminophen and Ibuprofen as a possible treatment. Condition(s) listed: Crohn's Disease (CD) and Dysmenorrhea Primary.
Participants are assigned to groups by chance (randomized).
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 18 to 44
- Women only
Some of the main requirements, copied from the record:
- Ages 18-44 years
- Assigned female at birth
- Crohn's Disease (CD) diagnosis
Plus 4 more requirement(s). There are also 7 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 24 participants are expected to take part.
- Start date: 2026-03-18.
- Main results expected around 2028-07 (estimate from the record).
- 1 study site listed (1 marked recruiting) in United States.
Main thing being measured
- Proportion of Participants Who Express Interest in the Study Out of Those Contacted (from first contact to informed consent, up to 2 years)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Not applicable |
| Study type | Interventional |
| Conditions | Crohn's Disease (CD); Dysmenorrhea Primary |
| Lead sponsor | University of North Carolina, Chapel Hill |
| Collaborators | American College of Gastroenterology; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Enrollment | 24 (estimated) |
| Start date | 2026-03-18 |
| Primary completion (est.) | 2028-07 |
| First posted | 2026-01-13 |
| Last updated | 2026-07-14 |
| Official title | Acetaminophen Versus Ibuprofen for Discomfort in Crohn's Disease (AVID-CD): An Open-Label Randomized Pilot Trial |
| ClinicalTrials.gov ID | NCT07337902 |
Interventions
- Acetaminophen (Other)
Participants will receive oral acetaminophen 650 mg three times daily for three days during two of four menstrual cycles by random assignment at the onset of cramps. - Ibuprofen (Other)
Participants will receive oral ibuprofen 400 mg three times daily for three days during two of four menstrual cycles by random assignment at the onset of cramps.
Full eligibility criteria (from the record)
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) <150 without use of corticosteroids * Self-reported primary dysmenorrhea * Regular menstrual cycles occurring every 23-35 days * Using an appropriate contraceptive method or abstinence 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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill | Chapel Hill, North Carolina | United States | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.