Pain Medicines for Period Pain in Crohn's Disease
(AVID-CD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore the effectiveness and safety of ibuprofen and acetaminophen for easing period cramps in women with Crohn's disease. Participants will try both medications over four menstrual cycles to determine which works better. The study will help prepare for a larger trial by assessing the ease of recruiting participants and completing study activities. Women with Crohn's disease who have regular menstrual cycles and experience significant period cramps might be a good fit for this trial.
As an unphased trial, this study offers participants the opportunity to contribute to important research that could improve future treatment options for women with Crohn's disease.
Will I have to stop taking my current medications?
The trial information does not specify if you need to stop taking your current medications. However, if you are taking hormone therapy or have a known sensitivity to ibuprofen or acetaminophen, you may not be eligible to participate.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that acetaminophen is generally safe for people with Crohn's disease. It doesn't cause stomach problems, making it a suitable option for pain relief in this group. Many doctors recommend it because it typically doesn't worsen Crohn's symptoms.
In contrast, ibuprofen, a non-steroidal anti-inflammatory drug (NSAID), can be more complicated for people with Crohn's disease. Some studies suggest that short-term use of ibuprofen might be well-tolerated without causing flare-ups. However, frequent or high-dose use can increase the risk of worsening symptoms.
Both medications are common and widely used, but these factors are important to consider for the safety of people with Crohn's.12345Why are researchers excited about this trial?
Researchers are excited about these treatments because they offer a new approach to managing period pain in people with Crohn's disease, which can be tough to handle with standard pain relief methods. The trial is exploring the alternating use of acetaminophen and ibuprofen, which are already well-known pain relievers but are being tested here in a unique sequence across menstrual cycles. This approach aims to understand if switching between these two medications can provide more effective or sustained relief compared to using just one, potentially leading to a personalized pain management strategy.
What evidence suggests that this trial's treatments could be effective for period pain in Crohn's disease?
Studies have shown that both ibuprofen and acetaminophen can relieve period cramps. Ibuprofen, an NSAID, reduces swelling and pain, and research shows it effectively eases menstrual pain. Acetaminophen is a pain reliever that also reduces fever and is often used for mild to moderate pain, including period cramps. This trial will evaluate the effects of these medications on people with Crohn's disease, as their effects are still under study. Current evidence suggests they can help with cramps, but people with Crohn's disease should consult their healthcare providers due to possible side effects.23678
Who Is on the Research Team?
Erica J Brenner, MD, MSCR
Principal Investigator
University of North Carolina, Chapel Hill
Are You a Good Fit for This Trial?
This trial is for women aged 18-44 with Crohn's Disease in stable remission, experiencing period pain and having regular menstrual cycles. Participants must not be using corticosteroids, should use contraception or practice abstinence.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants take either ibuprofen or acetaminophen for four menstrual cycles, with medication taken for three days during each cycle.
Follow-up
Participants are monitored for safety and effectiveness after treatment, including a remote interview to provide feedback on the study.
What Are the Treatments Tested in This Trial?
Interventions
- Acetaminophen
- Ibuprofen
Trial Overview
The AVID-CD study tests the effectiveness of ibuprofen versus acetaminophen on period cramps in women with Crohn's disease. It involves taking each medication for two menstrual cycles and tracking symptoms through surveys and stool samples.
How Is the Trial Designed?
4
Treatment groups
Experimental Treatment
Participants will receive medications for each of four menstrual cycles in the following order: 1. Ibuprofen 2. Acetaminophen 3. Ibuprofen 4. Acetaminophen
Participants will receive medications for each of four menstrual cycles in the following order: 1. Ibuprofen 2. Acetaminophen 3. Acetaminophen 4. Ibuprofen
Participants will receive medications for each of four menstrual cycles in the following order: 1. Acetaminophen 2. Ibuprofen 3. Ibuprofen 4. Acetaminophen
Participants will receive medications for each of four menstrual cycles in the following order: 1. Acetaminophen 2. Ibuprofen 3. Acetaminophen 4. Ibuprofen
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of North Carolina, Chapel Hill
Lead Sponsor
American College of Gastroenterology
Collaborator
Citations
Comparing Over the Counter Pain Medicines for ...
Participants will be assigned to take either ibuprofen or acetaminophen to help treat period cramps for four menstrual cycles in a row.
Pain Medicines for Period Pain in Crohn's Disease (AVID- ...
Trial Overview. The AVID-CD study tests the effectiveness of ibuprofen versus acetaminophen on period cramps in women with Crohn's disease.
Acetaminophen Versus Ibuprofen for Discomfort in Crohn's ...
We want to see how two common pain medicines-ibuprofen and acetaminophen-work and how safe they are for treating period cramps in people with Crohn's disease.
Dysmenorrhoea Efficacy Study: fixed dose combination ...
Study objectives. The primary objective of the study is to assess the efficacy of fixed dose combination tablets of. 200 mg ibuprofen plus 500 mg ...
Opioid Analgesics Do Not Improve Abdominal Pain or ...
Abdominal pain and opioid analgesic use are common in Crohn's disease (CD). We sought to identify factors associated with abdominal pain in ...
Systematic Review and Meta-analysis: Association Between ...
Contrary to generally accepted belief, we did not find a consistent association between NSAIDs use and risk of CD and UC exacerbation.
7.
everydayhealth.com
everydayhealth.com/digestive-health/should-you-limit-nsaids-with-crohns-disease/NSAIDs and Crohn's: Why to Avoid Them and 5 Alternatives
Some studies show acetaminophen (Tylenol) is one of the most common pain medications recommended and used for IBD. Although one meta-analysis ...
8.
bezzyibd.com
bezzyibd.com/discover/managing-ibd/health-are-nsaids-still-off-limits-for-people-with-ibd/Are NSAIDS Still Off Limits for People with IBD?
Acetaminophen is generally considered safe for people with IBD as it does not have any stomach-related side effects. It's a good choice for pain ...
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