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Nonsteroidal Anti-inflammatory Drug
Ibuprofen for Elevated PSA Levels
Phase 4
Recruiting
Led By Scott Eggener, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 6 weeks
Awards & highlights
Study Summary
This trial will test whether ibuprofen can lower PSA levels in men with slightly elevated levels, which may help prevent prostate cancer.
Who is the study for?
This trial is for men aged 18-80 with a PSA level over 3 ng/ml who are being considered for further prostate tests but have no symptoms of urinary infection or known prostate cancer. They must not be on blood thinners, anti-inflammatory drugs, have severe liver/kidney disease, history of GI bleeding, urethral catheter use recently, or NSAID allergies.Check my eligibility
What is being tested?
The study is testing the effects of taking ibuprofen (400 mg) on men with elevated PSA levels to see if it impacts their need for additional diagnostic procedures like MRI or biopsy.See study design
What are the potential side effects?
Possible side effects include digestive issues such as stomach pain and heartburn, increased risk of gastrointestinal bleeding especially in those with a history of ulcers or bleeds, and potential kidney problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 6 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change of serum PSA compared with baseline
Secondary outcome measures
Change of International Prostate Symptom Score (IPSS) compared with baseline
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IbuprofenExperimental Treatment1 Intervention
Participants receive Ibuprofen 400 mg tablet orally every 8 hours for 10 days
Group II: ControlActive Control1 Intervention
Participants receive no NSAIDs
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ibuprofen 400 mg
2021
Completed Phase 4
~1930
Find a Location
Who is running the clinical trial?
University of ChicagoLead Sponsor
1,004 Previous Clinical Trials
819,591 Total Patients Enrolled
Scott Eggener, MDPrincipal InvestigatorUniversity of Chicago
4 Previous Clinical Trials
512 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I currently have a urinary tract infection.I am a man aged 18-80 with a PSA level over 3 ng/ml and might need more tests.My kidney function is severely reduced.I am currently taking two antiplatelet medications or anticoagulants.I have had stomach bleeding or bad reactions to pain relievers before.I cannot take NSAIDs due to other health issues.I have a known bleeding disorder.I am currently taking anti-inflammatory or steroidal medications.I have severe liver disease with high liver enzyme levels.I don't have symptoms of a urinary tract infection.I have been diagnosed with prostate cancer.
Research Study Groups:
This trial has the following groups:- Group 1: Ibuprofen
- Group 2: Control
Awards:
This trial has 3 awards, including:- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this study limit its participants to those 35 years or younger?
"The age limit to participate in this trial is 80 years young."
Answered by AI
Do I meet the qualifications to take part in this research study?
"To be applicable for this study, male patients must be between 18 and 80 years old, have a PSA above 3 ng/ml, be considering additional diagnostic testing, have a normal digital rectal examination, and have no clinical symptoms concerning acute urinary tract infection. 200 participants are needed in total."
Answered by AI
Is it dangerous to take Ibuprofen 400 mg for a long period of time?
"Ibuprofen 400 mg is approved and, thus, considered safe."
Answered by AI
Are there any unfilled vacancies for participants in this experiment?
"Yes, you're right. The listing on clinicaltrials.gov shows that this trial is open for recruitment. It was first posted on August 1st, 2020 and was last updated on October 10th, 2020. They are looking for 200 people to participate at 1 site."
Answered by AI
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