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| Name | Class |
|---|---|
| American College of Gastroenterology | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acetaminophen, Ibuprofen, Acetaminophen, Ibuprofen | Experimental | Participants will receive medications for each of four menstrual cycles in the following order: 1. Acetaminophen 2. Ibuprofen 3. Acetaminophen 4. Ibuprofen |
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| Acetaminophen, Ibuprofen, Ibuprofen, Acetaminophen | Experimental | Participants will receive medications for each of four menstrual cycles in the following order: 1. Acetaminophen 2. Ibuprofen 3. Ibuprofen 4. Acetaminophen |
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| Ibuprofen, Acetaminophen, Ibuprofen, Acetaminophen | Experimental | Participants will receive medications for each of four menstrual cycles in the following order: 1. Ibuprofen 2. Acetaminophen 3. Ibuprofen 4. Acetaminophen |
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| Ibuprofen, Acetaminophen, Acetaminophen, Ibuprofen | Experimental | Participants will receive medications for each of four menstrual cycles in the following order: 1. Ibuprofen 2. Acetaminophen 3. Acetaminophen 4. Ibuprofen |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetaminophen | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from first contact to informed consent, up to 2 years |
| 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 | from first contact to informed consent, up to 2 years |
| 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 | enrollment to completion of study, approximately 2.5 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | first recruitment through screening, approximately 2 years |
| Reasons for Declining Study Participation by Category |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erica J Brenner, MD, MSCR | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599 | United States |
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina.
beginning 9 and continuing for 36 months following publication
Investigator who proposes to use the data has approved IRB, IEC, or REB and an executed data use/sharing agreement with the University of North Carolina.
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Ibuprofen | Other | 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. |
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Recruitment Barriers will be summarized by the number of participants among those eligible who have been screened listed by reason(s) for declining participation. |
| first contact through screening, approximately 2 years |
| 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 | first contact through end of study, approximately 2 years |
| Number of subjects who return all stool samples | Adherence Rates will be summarized as the number of subjects who return all stool samples | enrollment through end of study, approximately 5 months |
| Number of participants who take the study drugs per protocol | Adherence Rates will be summarized by the number of participants who take the study drugs per protocol | enrollment through end of study, approximately 5 months |
| Number of participants who complete the dysmenorrhea surveys | Adherence rates will be summarized by the number of participants who complete the dysmenorrhea surveys | enrollment through end of study, approximately 5 months |
| Number of subjects who complete the Irritable Bowel Syndrome (IBD) surveys | Adherence Rates will be summarized by the number of subjects who complete the Irritable Bowel Syndrome (IBD) surveys | enrollment through end of study, approximately 5 months |
| Number of subjects who complete all study activities per protocol | Adherence rates will be summarized by the number of subjects who complete all study activities per protocol | enrollment through end of study, approximately 5 months |
| Number of participants who delay participation due to lack of dysmenorrhea | Adherence barriers will be summarized by the number of participants who delay participation due to lack of dysmenorrhea | enrollment to end of study, approximately 5 months |
| Number of participants who delay participation or drop out due to active IBD | Adherence Barriers will be summarized by the number of participants who delay participation or drop out due to active IBD | enrollment to end of study, approximately 5 months |
| Number of participants who use study drug for other indications during the study | Adherence Barriers will be summarized by number of participants who use study drug for other indications during the study | enrollment to end of study, approximately 5 months |
| Number of participants who use a rescue medication | Adherence Barriers will be summarized by number of participants who use a rescue medication | enrollment to end of study, approximately 5 months |
| Reported barriers to compliance with procedures | Participant qualitative interview feedback will be summarized by listing of reported barriers to compliance with procedures | following completion of fourth menstrual cycle, single interview lasting approximately one hour |
| Acceptability of study intervention and protocol | Participant qualitative interview feedback will be summarized by number of participants reporting acceptability of study intervention and protocol | following completion of fourth menstrual cycle, single interview lasting approximately one hour |
| Areas of confusion regarding instructions or protocol | Participant qualitative interview feedback will be summarized by a list of areas of confusion regarding instructions or protocol | following completion of fourth menstrual cycle, single interview lasting approximately one hour |
| Interest in stool bio-banking for future research | Participant qualitative interview feedback will be summarized by number of subjects interested in stool bio-banking for future research | following completion of fourth menstrual cycle, single interview lasting approximately one hour |
| D007410 | Intestinal Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |