Clinical Study Evaluating the Effect of Nicorandil as Anti-inflammatory and Immune Modulatory in Patients With Rheumatoid Arthritis
New trial tests Nicorandil for rheumatoid arthritis inflammation
Plain English Summary
Nicorandil as Anti-inflammatory in Rheumatoid Arthritis is a Phase 3 clinical trial sponsored by Tanta University studying Rhumatoid Arthisis. This trial tests if Nicorandil can reduce inflammation and immune responses in rheumatoid arthritis. It is for adults with active rheumatoid arthritis who are not in remission and are already on standard treatments. Participants will receive either Nicorandil or a placebo, and their progress will be monitored for 3 months. Standard treatments for rheumatoid arthritis include other medications and lifestyle changes. The trial aims to enroll 46 participants.
Official Summary
This study aims to evaluate the possible efficacy and safety of nicorandil as anti-inflammatory in managing patients with active rheumatoid arthritis.
Who Can Participate
Here is what you need to know about eligibility for this trial. Adults with active rheumatoid arthritis (joint pain and swelling) that is not controlled by current medications. Patients must have a DAS-28 score above 2.6 and be taking conventional disease-modifying antirheumatic drugs (DMARDs). People with heart problems, diabetes, active infections, severe kidney or liver issues, or those taking biological DMARDs or high doses of steroids cannot join. Pregnant or breastfeeding women, and those with known allergies to the study drug are also excluded. This trial is studying Rhumatoid Arthisis, so participants generally need a confirmed diagnosis.
What They're Measuring
The study will measure changes in joint pain and function scores to see if Nicorandil improves how patients feel and move. The specific primary outcome measures are: change in DAS-28-CRP score (3 months); change in Multidimensional Health Assessment Questionnaire (MDHAQ) scores. (3 months). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 3, the final and most rigorous stage before seeking FDA approval. Phase 3 trials involve 300-3,000+ patients across multiple sites and compare the new treatment directly against the current standard of care. These pivotal trials generate the evidence needed for regulatory review. About 58% of Phase 3 drugs receive FDA approval. Successful Phase 3 results typically lead to a New Drug Application submission.
Why This Trial Matters
This trial aims to find a new way to manage inflammation in rheumatoid arthritis, addressing a need for more effective anti-inflammatory treatments. As a Phase 3 trial, positive results could directly lead to FDA approval, making this treatment available to the broader patient population. This research targets Rhumatoid Arthisis, where improved treatment options are needed.
Investor Insight
This Phase 3 trial for an existing drug in a new indication suggests potential for market expansion if successful, though competition in RA is high. Phase 3 trials have approximately a 50-60% chance of gaining FDA approval if they reach this stage.
Is This Trial Right for Me?
Ask your doctor if Nicorandil is a suitable option for your rheumatoid arthritis and what potential benefits and risks it may have. Participation involves taking study medication daily and attending regular clinic visits for assessments over 3 months. You will need to provide blood samples to monitor specific markers of inflammation and immune activity. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: RANDOMIZED
- Model: PARALLEL
- Masking: NONE
- Enrollment: 46 participants
Interventions
- DRUG: Nicorandil 10 MG Oral Tablet — Nicorandil 10 MG Oral Tablet
Primary Outcomes
- change in DAS-28-CRP score (3 months)
- change in Multidimensional Health Assessment Questionnaire (MDHAQ) scores. (3 months)
Secondary Outcomes
- The change in the serum level of 8-hydroxydeoxyguanosine (8-OHdG). (3 months)
- The change in the serum level of Interleukin 6 (IL-6). (3 months)
- The change in the serum level of C- reactive protein (CRP). (3 months)
Full Eligibility Criteria
Inclusion Criteria: * Patients with active rheumatoid arthritis (not in remission) according to American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) i.e., 28 joints disease activity score (DAS-28) \>2.6. * Patients receiving the conventional DMARDs Exclusion Criteria: * Patients with heart disease (congestive heart failure, arrhythmia and ischemic heart disease), diabetes, active infection, and other illness except rheumatoid arthritis. * Patients with severe renal and hepatic dysfunction. - Patients receiving biological DMARDs. * Patients receiving oral prednisolone greater than 15mg/day. * Patients with hypersensitivity to study medications. * Patients using antioxidants. * Pregnant and lactating females.
Trial Locations
- Tanta university, Tanta, Gharbia Governorate, Egypt
Frequently Asked Questions
What is clinical trial NCT07516769?
NCT07516769 is a Phase 3 INTERVENTIONAL study titled "Nicorandil as Anti-inflammatory in Rheumatoid Arthritis." It is currently not yet recruiting and is sponsored by Tanta University. The trial targets enrollment of 46 participants.
What conditions does NCT07516769 study?
This trial investigates treatments for Rhumatoid Arthisis. The primary condition under study is Rhumatoid Arthisis.
What treatments are being tested in NCT07516769?
The interventions being studied include: Nicorandil 10 MG Oral Tablet (DRUG). Nicorandil 10 MG Oral Tablet
What does Phase 3 mean for NCT07516769?
Phase 3 trials are large-scale studies involving 300-3,000+ patients that compare the new treatment against existing standard treatments. Positive Phase 3 results are typically required for FDA approval.
What is the current status of NCT07516769?
This trial is currently "Not Yet Recruiting." It started on 2026-04. The estimated completion date is 2027-04.
Who is sponsoring NCT07516769?
NCT07516769 is sponsored by Tanta University. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07516769?
The trial aims to enroll 46 participants. The trial has not yet started recruiting.
How is NCT07516769 designed?
This is a interventional study, uses randomized allocation, follows a parallel design, employs none masking.
What are the primary outcomes being measured in NCT07516769?
The primary outcome measures are: change in DAS-28-CRP score (3 months); change in Multidimensional Health Assessment Questionnaire (MDHAQ) scores. (3 months). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07516769 being conducted?
This trial is being conducted at 1 site, including Tanta, Gharbia Governorate (Egypt).
Where can I find official information about NCT07516769?
The official record for NCT07516769 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07516769. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07516769 testing in simple terms?
This trial tests if Nicorandil can reduce inflammation and immune responses in rheumatoid arthritis. It is for adults with active rheumatoid arthritis who are not in remission and are already on standard treatments.
Why is this trial significant?
This trial aims to find a new way to manage inflammation in rheumatoid arthritis, addressing a need for more effective anti-inflammatory treatments. As a Phase 3 trial, positive results could lead directly to regulatory approval and new treatment options for patients.
What are the potential risks of participating in NCT07516769?
Common side effects may include headache, dizziness, and nausea. There is a risk of allergic reactions to the study medication. Potential for interactions with other medications you are taking. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07516769?
Ask your doctor if Nicorandil is a suitable option for your rheumatoid arthritis and what potential benefits and risks it may have. Participation involves taking study medication daily and attending regular clinic visits for assessments over 3 months. You will need to provide blood samples to monitor specific markers of inflammation and immune activity. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07516769 signal from an investment perspective?
This Phase 3 trial for an existing drug in a new indication suggests potential for market expansion if successful, though competition in RA is high. This is a Phase 3 trial, which is the final pivotal stage before potential regulatory submission.
What happens if the treatment in this trial doesn't work?
Participants will receive either Nicorandil or a placebo, and their progress will be monitored for 3 months. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
More Rhumatoid Arthisis Trials
This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.