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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-44
SponsorUniversity of North Carolina, Chapel Hill

About this 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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Acetaminophen
  • Ibuprofen

Treatment groups

24 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of North Carolina, Chapel Hill

Lead sponsor

American College of Gastroenterology

Collaborator