Crohn's Disease (CD), Dysmenorrhea Primary
Conditions
Keywords
Crohn's Disease
Brief 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. 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.
Interventions
OTHERAcetaminophen
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.
OTHERIbuprofen
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.
Sponsors
University of North Carolina, Chapel Hill
American College of Gastroenterology
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Participants Who Express Interest in the Study Out of Those Contacted | 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 | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants who meet exclusion criteria out ot the Total Screened | first recruitment through screening, approximately 2 years | Recruitment Barriers will be determined among screened participants by the number who meet exclusion criteria |
| Reasons for Declining Study Participation by Category | 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. |
| Number of Participants who consented that do not complete baseline visit | 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 |
| Number of subjects who return all stool samples | enrollment through end of study, approximately 5 months | Adherence Rates will be summarized as the number of subjects who return all stool samples |
| Number of participants who take the study drugs per protocol | 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 |
| Number of participants who complete the dysmenorrhea surveys | enrollment through end of study, approximately 5 months | Adherence rates will be summarized by the number of participants who complete the dysmenorrhea surveys |
| Number of subjects who complete the Irritable Bowel Syndrome (IBD) surveys | 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 |
| Number of subjects who complete all study activities per protocol | 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 |
| Number of participants who delay participation due to lack of dysmenorrhea | 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 |
| Number of participants who delay participation or drop out due to active IBD | 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 |
| Number of participants who use study drug for other indications during the study | 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 |
| Number of participants who use a rescue medication | enrollment to end of study, approximately 5 months | Adherence Barriers will be summarized by number of participants who use a rescue medication |
| Reported barriers to compliance with procedures | 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 |
| Acceptability of study intervention and protocol | 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 |
| Areas of confusion regarding instructions or protocol | 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 |
| Interest in stool bio-banking for future research | 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 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORErica J Brenner, MD, MSCR
University of North Carolina, Chapel Hill
Outcome results
None listed