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

RecruitingNAAges 18 Years - 44 YearsFemaleUniversity of North Carolina, Chapel Hill
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In plain words

What the trial is, and whether it could suit you

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 assig

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
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What it tests

  • Acetaminophen
  • Ibuprofen
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Where

1 site
University of North Carolina at Chapel Hill
Chapel Hill, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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