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
This trial does not accept healthy volunteersQualifiers
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
Design model
Crossover
Treatments tested in this trial
Acetaminophen
Other interventionParticipants 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.
Ibuprofen
Other interventionParticipants 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.
Treatment groups
24 Participants
are divided into 4 treatment groupsGroup A: Acetaminophen, Ibuprofen, Acetaminophen, IbuprofenExperimental treatment 2 interventions
Group B: Acetaminophen, Ibuprofen, Ibuprofen, AcetaminophenExperimental treatment 2 interventions
Group C: Ibuprofen, Acetaminophen, Ibuprofen, AcetaminophenExperimental treatment 2 interventions
Group D: Ibuprofen, Acetaminophen, Acetaminophen, IbuprofenExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Proportion of Participants Who Express Interest in the Study Out of Those Contacted
Accrual will be determined as the proportion of participants who express interest in the study out of those contacted
Time frame
from first contact to informed consent, up to 2 years2
Proportion of participants who enroll out of those who expressed interest in the study
Accrual will be determined by the 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 years3
Proportion of participants who meet the minimum adherence needed to contribute effectively to a subsequent study out of those randomized
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
Time frame
enrollment to completion of study, approximately 2.5 yearsSecondary outcomes
1
Number of Participants who meet exclusion criteria out ot the Total Screened
Recruitment Barriers will be determined among screened participants by the number who meet exclusion criteria
Time frame
first recruitment through screening, approximately 2 years2
Reasons for Declining Study Participation by Category
Recruitment Barriers will be summarized by the number of participants among those eligible who have been screened listed by reason(s) for declining participation.
Time frame
first contact through screening, approximately 2 years3
Number of Participants who consented that do not complete baseline visit
Recruitment Barriers will be summarized as the number of participants who consented that do not complete baseline visit
Time frame
first contact through end of study, approximately 2 years4
Number of subjects who return all stool samples
Adherence Rates will be summarized as the number of subjects who return all stool samples
Time frame
enrollment through end of study, approximately 5 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of North Carolina, Chapel Hill
Lead sponsor
American College of Gastroenterology
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov