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

NCT07337902 | Recruiting

• 1 other identifier: 24-2940
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Crohn's Disease (CD); Dysmenorrhea Primary

Keywords

Crohn's Disease

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (16)

• Number of Participants who meet exclusion criteria out ot the Total Screened

  first recruitment through screening, approximately 2 years

• Reasons for Declining Study Participation by Category

  first contact through screening, approximately 2 years

• 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

  enrollment through end of study, approximately 5 months

• Number of participants who take the study drugs per protocol

  enrollment through end of study, approximately 5 months

Study Arms (4)

Acetaminophen, Ibuprofen, Acetaminophen, Ibuprofen

EXPERIMENTAL

Participants will receive medications for each of four menstrual cycles in the following order: 1. Acetaminophen 2. Ibuprofen 3. Acetaminophen 4. Ibuprofen

Other: Acetaminophen; Other: Ibuprofen

Acetaminophen, Ibuprofen, Ibuprofen, Acetaminophen

EXPERIMENTAL

Participants will receive medications for each of four menstrual cycles in the following order: 1. Acetaminophen 2. Ibuprofen 3. Ibuprofen 4. Acetaminophen

Other: Acetaminophen; Other: Ibuprofen

Ibuprofen, Acetaminophen, Ibuprofen, Acetaminophen

EXPERIMENTAL

Participants will receive medications for each of four menstrual cycles in the following order: 1. Ibuprofen 2. Acetaminophen 3. Ibuprofen 4. Acetaminophen

Other: Acetaminophen; Other: Ibuprofen

Ibuprofen, Acetaminophen, Acetaminophen, Ibuprofen

EXPERIMENTAL

Participants will receive medications for each of four menstrual cycles in the following order: 1. Ibuprofen 2. Acetaminophen 3. Acetaminophen 4. Ibuprofen

Other: Acetaminophen; Other: Ibuprofen

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.

Also known as: Tylenol

Acetaminophen, Ibuprofen, Acetaminophen, Ibuprofen; Acetaminophen, Ibuprofen, Ibuprofen, Acetaminophen; Ibuprofen, Acetaminophen, Acetaminophen, Ibuprofen; Ibuprofen, Acetaminophen, Ibuprofen, Acetaminophen

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.

Also known as: Advil

Acetaminophen, Ibuprofen, Acetaminophen, Ibuprofen; Acetaminophen, Ibuprofen, Ibuprofen, Acetaminophen; Ibuprofen, Acetaminophen, Acetaminophen, Ibuprofen; Ibuprofen, Acetaminophen, Ibuprofen, Acetaminophen

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• American College of Gastroenterology: collaborator
• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Acetaminophen; Ibuprofen

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids

Study Officials

• Erica J Brenner, MD, MSCR

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 13, 2026
• Study Start: March 18, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: beginning 9 and continuing for 36 months following publication
• 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.

Locations

US (1)