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

March 18, 2026 updated by: University of North Carolina, Chapel Hill

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants Who Express Interest in the Study Out of Those Contacted
Time Frame: from first contact to informed consent, up to 2 years
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
Time Frame: from first contact to informed consent, up to 2 years
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
Time Frame: enrollment to completion of study, approximately 2.5 years
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants who meet exclusion criteria out ot the Total Screened
Time Frame: first recruitment through screening, approximately 2 years
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
Time Frame: first contact through screening, approximately 2 years
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
Time Frame: first contact through end of study, approximately 2 years
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
Time Frame: enrollment through end of study, approximately 5 months
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
Time Frame: enrollment through end of study, approximately 5 months
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
Time Frame: enrollment through end of study, approximately 5 months
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
Time Frame: enrollment through end of study, approximately 5 months
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
Time Frame: enrollment through end of study, approximately 5 months
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
Time Frame: enrollment to end of study, approximately 5 months
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
Time Frame: enrollment to end of study, approximately 5 months
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
Time Frame: enrollment to end of study, approximately 5 months
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
Time Frame: enrollment to end of study, approximately 5 months
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
Time Frame: following completion of fourth menstrual cycle, single interview lasting approximately one hour
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
Time Frame: following completion of fourth menstrual cycle, single interview lasting approximately one hour
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
Time Frame: following completion of fourth menstrual cycle, single interview lasting approximately one hour
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
Time Frame: following completion of fourth menstrual cycle, single interview lasting approximately one hour
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
American College of Gastroenterology

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Erica J Brenner, MD, MSCR, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 18, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 13, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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