Crohn's Disease (CD)AVID-CDNCT07337902
Comparing Over the Counter Pain Medicines for Discomfort in Crohn's Disease (AVID-CD)
A study testing Acetaminophen and Ibuprofen in people with Crohn's Disease (CD) and Dysmenorrhea Primary, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Crohn's Disease (CD), Dysmenorrhea Primary
- What is being tested?
- Acetaminophen and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2026to Jul 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Rachel Cooke, MS, 919-964-2141, rachel_cooke@med.unc.edu
About this study
Official title: 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.
Read more
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
- Being tested
- Acetaminophen, Ibuprofen
- Keywords
- Crohn's Disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenOther
Also called Tylenol
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.
IbuprofenOther
Also called Advil
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Other: Acetaminophen; Other: Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: enrollment to completion of study, approximately 2.5 years
Secondary outcomes (16)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: following completion of fourth menstrual cycle, single interview lasting approximately one hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start18 Mar 2026
- Primary completionJul 2028 (estimated)
- Study completionJul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's Disease (CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Gastroenterology, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Erica J Brenner, MD, MSCR, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337902
- Sponsor's protocol ID
- 24-2940
- Other IDs
- 1K23DK146181-01
- Acronym
- AVID-CD
- Status last verified
- Jul 2026
- First submitted
- 19 Dec 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acetaminophen Versus Ibuprofen for Discomfort in Crohn's Disease (AVID-CD): An Open-Label Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT07337902
- Acronym / sponsor ID
- AVID-CD / 24-2940
- Conditions
- Crohn's Disease (CD), Dysmenorrhea Primary
- Keywords
- Crohn's Disease
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- American College of Gastroenterology, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 18 Mar 2026 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2028 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen, Ibuprofen, Acetaminophen, Ibuprofen | Experimental | Other: Acetaminophen, Other: IbuprofenParticipants will receive medications for each of four menstrual cycles in the following order: 1. Acetaminophen 2. Ibuprofen 3. Acetaminophen 4. Ibuprofen |
| Acetaminophen, Ibuprofen, Ibuprofen, Acetaminophen | Experimental | Other: Acetaminophen, Other: IbuprofenParticipants will receive medications for each of four menstrual cycles in the following order: 1. Acetaminophen 2. Ibuprofen 3. Ibuprofen 4. Acetaminophen |
| Ibuprofen, Acetaminophen, Ibuprofen, Acetaminophen | Experimental | Other: Acetaminophen, Other: IbuprofenParticipants will receive medications for each of four menstrual cycles in the following order: 1. Ibuprofen 2. Acetaminophen 3. Ibuprofen 4. Acetaminophen |
| Ibuprofen, Acetaminophen, Acetaminophen, Ibuprofen | Experimental | Other: Acetaminophen, Other: IbuprofenParticipants will receive medications for each of four menstrual cycles in the following order: 1. Ibuprofen 2. Acetaminophen 3. Acetaminophen 4. Ibuprofen |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcetaminophenAlso: TylenolParticipants 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 | Acetaminophen, Ibuprofen, Acetaminophen, Ibuprofen, Acetaminophen, Ibuprofen, Ibuprofen, Acetaminophen, Ibuprofen, Acetaminophen, Acetaminophen, Ibuprofen, Ibuprofen, Acetaminophen, Ibuprofen, Acetaminophen |
| IbuprofenAlso: AdvilParticipants 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 | Acetaminophen, Ibuprofen, Acetaminophen, Ibuprofen, Acetaminophen, Ibuprofen, Ibuprofen, Acetaminophen, Ibuprofen, Acetaminophen, Acetaminophen, Ibuprofen, Ibuprofen, Acetaminophen, Ibuprofen, Acetaminophen |
Primary outcome
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
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
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
16 secondary outcomes
Number of Participants who meet exclusion criteria out ot the Total Screened
Time frame: first recruitment through screening, approximately 2 years
Reasons for Declining Study Participation by Category
Time frame: 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
Number of subjects who return all stool samples
Time frame: 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
Number of participants who complete the dysmenorrhea surveys
Time frame: 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
Number of subjects who complete all study activities per protocol
Time frame: 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
Number of participants who delay participation or drop out due to active IBD
Time frame: 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
Number of participants who use a rescue medication
Time frame: 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
Acceptability of study intervention and protocol
Time frame: 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
Interest in stool bio-banking for future research
Time frame: following completion of fourth menstrual cycle, single interview lasting approximately one hour
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
University of North Carolina at Chapel Hill
Chapel Hill, United States
Erica J Brenner, MD, MSCR principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acetaminophen and Ibuprofen in people with Crohn's Disease (CD) and Dysmenorrhea Primary, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2026.