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NCT Number: NCT07337902

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

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.

Recruiting

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Key information

Conditions

Crohn's Disease (CD) Crohn Disease Digestive System Diseases Dysmenorrhea Primary Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–44 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location status: Recruiting

Location contact

Rachel Cooke, MS

CONTACT

[email protected]

919-964-2141

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Tylenol

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.

Other names: Advil

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. 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

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • American College of Gastroenterology
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

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

Acronym: AVID-CD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 13, 2026
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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