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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 44 Years
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 days
  • Procedures mentioned: Questionnaires, Blood draws, Physical exams, Interviews

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study will help plan a larger study of ibuprofen and acetaminophen for period cramps in women with Crohn's disease. Participants will take each medicine for two menstrual cycles. Researchers will check how well people can follow and finish the study plan.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are 18–44 years old and were assigned female at birth.
  • Have been diagnosed with Crohn's disease.
  • Have stable Crohn's disease with few or no symptoms, a disease activity score below 150, and no use of steroid medicines.
  • Report having period cramps that are not caused by another pelvic condition.
  • Have regular periods every 23–35 days.
  • Use an accepted birth control method or do not have sex.

Who can't join

  • Have endometriosis or adenomyosis (uterus-like tissue growing outside the uterus or into its muscle), polycystic ovarian syndrome (a hormone condition), growths in the uterus, long-term infection in the pelvic area, or another pelvic health condition.
  • Have had surgery in the pelvic area, including removal of the uterus.
  • Are pregnant or plan to become pregnant during the study.
  • Started birth control pills less than 3 months ago, had an unstable dose or switched pills in the last 3 months, or plan to switch pills during the study.
  • Take hormones, such as estrogen or progesterone, that are not part of birth control.
  • Have an allergy to ibuprofen or acetaminophen, or another medical reason you cannot take them.
  • Cannot complete the online study surveys, even with training, or do not have access to a smartphone or computer.
  • Cannot speak and read English.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

NC