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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Dysmenorrhea Primary; Crohn's Disease (CD)
• Intervention / Treatment: Other: Acetaminophen; Other: Ibuprofen

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina at Chapel Hill
      • Contact: Rachel Cooke, MS; Phone Number: 919-964-2141; Email: rachel_cooke@med.unc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acetaminophen, Ibuprofen, Acetaminophen, Ibuprofen; Participants will receive medications for each of four menstrual cycles in the following order: 1. Acetaminophen 2. Ibuprofen 3. Acetaminophen 4. Ibuprofen	Other: Acetaminophen; 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.; Other Names: Tylenol; Other: Ibuprofen; 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.; Other Names: Advil
Experimental: Acetaminophen, Ibuprofen, Ibuprofen, Acetaminophen; Participants will receive medications for each of four menstrual cycles in the following order: 1. Acetaminophen 2. Ibuprofen 3. Ibuprofen 4. Acetaminophen	Other: Acetaminophen; 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.; Other Names: Tylenol; Other: Ibuprofen; 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.; Other Names: Advil
Experimental: Ibuprofen, Acetaminophen, Ibuprofen, Acetaminophen; Participants will receive medications for each of four menstrual cycles in the following order: 1. Ibuprofen 2. Acetaminophen 3. Ibuprofen 4. Acetaminophen	Other: Acetaminophen; 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.; Other Names: Tylenol; Other: Ibuprofen; 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.; Other Names: Advil
Experimental: Ibuprofen, Acetaminophen, Acetaminophen, Ibuprofen; Participants will receive medications for each of four menstrual cycles in the following order: 1. Ibuprofen 2. Acetaminophen 3. Acetaminophen 4. Ibuprofen	Other: Acetaminophen; 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.; Other Names: Tylenol; Other: Ibuprofen; 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.; Other Names: Advil

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants Who Express Interest in the Study Out of Those Contacted	Accrual will be determined as the proportion of participants who express interest in the study out of those contacted	from first contact to informed consent, up to 2 years
Proportion of participants who enroll out of those who expressed interest in the study	Accrual will be determined by the proportion of participants who enroll out of those who expressed interest in the study	from first contact to informed consent, up to 2 years
Proportion of participants who meet the minimum adherence needed to contribute effectively to a subsequent study out of those randomized	Protocol Adherence will be determined by the proportion of participants who meet the minimum adherence needed to contribute effectively to a subsequent study out of those randomized	enrollment to completion of study, approximately 2.5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants who meet exclusion criteria out ot the Total Screened	Recruitment Barriers will be determined among screened participants by the number who meet exclusion criteria	first recruitment through screening, approximately 2 years
Reasons for Declining Study Participation by Category	Recruitment Barriers will be summarized by the number of participants among those eligible who have been screened listed by reason(s) for declining participation.	first contact through screening, approximately 2 years
Number of Participants who consented that do not complete baseline visit	Recruitment Barriers will be summarized as the number of participants who consented that do not complete baseline visit	first contact through end of study, approximately 2 years
Number of subjects who return all stool samples	Adherence Rates will be summarized as the number of subjects who return all stool samples	enrollment through end of study, approximately 5 months
Number of participants who take the study drugs per protocol	Adherence Rates will be summarized by the number of participants who take the study drugs per protocol	enrollment through end of study, approximately 5 months
Number of participants who complete the dysmenorrhea surveys	Adherence rates will be summarized by the number of participants who complete the dysmenorrhea surveys	enrollment through end of study, approximately 5 months
Number of subjects who complete the Irritable Bowel Syndrome (IBD) surveys	Adherence Rates will be summarized by the number of subjects who complete the Irritable Bowel Syndrome (IBD) surveys	enrollment through end of study, approximately 5 months
Number of subjects who complete all study activities per protocol	Adherence rates will be summarized by the number of subjects who complete all study activities per protocol	enrollment through end of study, approximately 5 months
Number of participants who delay participation due to lack of dysmenorrhea	Adherence barriers will be summarized by the number of participants who delay participation due to lack of dysmenorrhea	enrollment to end of study, approximately 5 months
Number of participants who delay participation or drop out due to active IBD	Adherence Barriers will be summarized by the number of participants who delay participation or drop out due to active IBD	enrollment to end of study, approximately 5 months
Number of participants who use study drug for other indications during the study	Adherence Barriers will be summarized by number of participants who use study drug for other indications during the study	enrollment to end of study, approximately 5 months
Number of participants who use a rescue medication	Adherence Barriers will be summarized by number of participants who use a rescue medication	enrollment to end of study, approximately 5 months
Reported barriers to compliance with procedures	Participant qualitative interview feedback will be summarized by listing of reported barriers to compliance with procedures	following completion of fourth menstrual cycle, single interview lasting approximately one hour
Acceptability of study intervention and protocol	Participant qualitative interview feedback will be summarized by number of participants reporting acceptability of study intervention and protocol	following completion of fourth menstrual cycle, single interview lasting approximately one hour
Areas of confusion regarding instructions or protocol	Participant qualitative interview feedback will be summarized by a list of areas of confusion regarding instructions or protocol	following completion of fourth menstrual cycle, single interview lasting approximately one hour
Interest in stool bio-banking for future research	Participant qualitative interview feedback will be summarized by number of subjects interested in stool bio-banking for future research	following completion of fourth menstrual cycle, single interview lasting approximately one hour

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: American College of Gastroenterology
• Investigators: Principal Investigator: Erica J Brenner, MD, MSCR, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): March 18, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: January 6, 2026
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): March 23, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Crohn's Disease
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease; Organic Chemicals; Carboxylic Acids; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Acids, Carbocyclic; Phenylpropionates; Acetaminophen; Ibuprofen
• Other Study ID Numbers: 24-2940

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina.
• IPD Sharing Time Frame: beginning 9 and continuing for 36 months following publication
• IPD Sharing Access Criteria: Investigator who proposes to use the data has approved IRB, IEC, or REB and an executed data use/sharing agreement with the University of North Carolina.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No