What side effects are associated with this type of intervention?

Common treatments targeting the metabolism of Prostaglandin D2, such as non-steroidal anti-inflammatory drugs (NSAIDs), are associated with several side effects. These include gastrointestinal issues like ulcers and bleeding, cardiovascular risks such as increased chances of heart attack and stroke, and renal complications including kidney damage. Additionally, NSAIDs can cause allergic reactions and exacerbate conditions like asthma in susceptible individuals.

What prior FDA approvals exist?

The FDA has approved several non-steroidal anti-inflammatory drugs (NSAIDs) that target the cyclooxygenase enzymes (COX-1 and COX-2), which are involved in the metabolism of Prostaglandin D2 (PGD2). Notable drugs include celecoxib, a COX-2 selective inhibitor, which has been used for conditions like familial adenomatous polyposis (FAP) due to its ability to reduce polyp formation. Other NSAIDs, such as rofecoxib and diclofenac, have also been studied for their effects on prostaglandin pathways. These drugs inhibit the enzymes responsible for converting arachidonic acid to prostaglandins, thereby impacting the metabolic pathways involving PGD2 and its conversion to 11-dehydro-thromboxane B2.

What other types of research exist?

As of the latest updates, no specific novel alternatives to the metabolic pathway study of Prostaglandin D2 (enzymatic conversion to 11-dehydro-thromboxane B2) have been explicitly mentioned. However, there is ongoing research into disease-modifying osteoarthritis drugs (DMOADs) and structure-modifying osteoarthritis drugs (SMOADs) that target different pain pathways and inhibit catabolic processes. Additionally, new analgesics targeting nerve growth factor are being developed. These investigational approaches may offer new insights and potential treatments related to prostaglandin metabolism and its effects.

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Niacin and Aspirin for Prostaglandin D2 Metabolism Pathways

Q: What is the mechanism of action of this treatment?

The metabolism of Prostaglandin D2 (PGD2) involves its conversion by cyclooxygenase enzymes, which are the targets of non-steroidal anti-inflammatory drugs (NSAIDs). These drugs inhibit the cyclooxygenase enzymes, thereby reducing the formation of prostaglandins, including PGD2. The trial studying the metabolic pathway of PGD2 to 11-dehydro-thromboxane B2 aims to uncover additional metabolic routes that could influence inflammatory and thrombotic processes. Understanding these pathways is crucial for patients because it can lead to more targeted therapies that modulate specific prostaglandin metabolites, potentially improving the management of conditions associated with inflammation and thrombosis.

Phase < 1

Waitlist Available

Led By Claus M Schneider, PhD

Research Sponsored by Vanderbilt University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Normal, healthy volunteers not currently taking any medication

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-10 hours

Awards & highlights

Summary

This trial uses niacin and aspirin to study their effects on a body chemical in healthy volunteers. Researchers measure chemicals in urine and blood to understand how this chemical is broken down.

Who is the study for?

This trial is for healthy volunteers who aren't on any medications. It's not open to those who've taken anti-inflammatory or over-the-counter pain meds like NSAIDs in the two weeks before the study starts.

What is being tested?

The study is looking into a potential new pathway between two prostaglandins by giving participants niacin, PGD2, and aspirin to see how these substances affect prostaglandin metabolism.

What are the potential side effects?

Possible side effects from niacin include flushing and itching, aspirin may cause stomach upset or bleeding issues, and PGD2's effects are less known but could involve changes in blood pressure or immune responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am healthy and not on any medications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-10 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-10 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-10 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

prostaglandin metabolites

Trial Design

4Treatment groups

Experimental Treatment

Group I: niacin + regular-strength aspirinExperimental Treatment2 Interventions

Volunteers will provide a urine sample. They will receive 7 tablets of regular-strength aspirin (325 mg) and be instructed to take one tablet daily for 7 days. On the seventh day, they return to have blood drawn, urine collected, and receive niacin as described in arm 1.

Group II: niacin + low-dose aspirinExperimental Treatment2 Interventions

Volunteers will provide a urine sample. They will receive 7 tablets of low-dose aspirin (81 mg) and be instructed to take one tablet daily for 7 days. On the seventh day, they return to have blood drawn, urine collected, and receive niacin as described in arm 1.

Group III: niacinExperimental Treatment1 Intervention

Blood (10 ml) will be drawn from the subject. Immediately before or after the blood draw the subject will collect a urine (3-10 ml) sample. After the baseline blood draw and the urine sample is collected the subject will take 500 mg of niacin. The niacin will not be an extended release formulation. Subjects will be encouraged to drink plenty of water during the study. Subjects are instructed to collect urine 1, 2, 4, 6, 8, and 10 hours after niacin administration. Subjects will collect their urine in separate plastic tubes that will be provided to them. Approximately 1-2 h after niacin administration a second blood sample (10 ml) will be drawn from the subject.

Group IV: deuterated PGD2Experimental Treatment1 Intervention

Volunteers will come to the clinical research center. Volunteers will provide a urine sample. The volunteers will be fitted to record an electrocardiogram (ECG) and blood pressure. ECG will be recorded continuously. Blood pressure will be taken at baseline and every 10 minutes thereafter for one hour. The solution with deuterated PGD2 (10 microgram) will be infused over the course of 30 min. Volunteers will be monitored for 1 h after the end of the infusion, and volunteers will start collecting urine in intervals up to 10 h. Infusion of the deuterated PGD2 solution will be performed in the presence of a physician. The injection solution will be prepared by Vanderbilt University Medical Center (VUMC) Investigational Drug Services. The solution will be sterile and pyrogen free.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

niacin

2003

Completed Phase 4

~390

aspirin

2000

Completed Phase 4

~16940

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The metabolism of Prostaglandin D2 (PGD2) involves its conversion by cyclooxygenase enzymes, which are the targets of non-steroidal anti-inflammatory drugs (NSAIDs). These drugs inhibit the cyclooxygenase enzymes, thereby reducing the formation of prostaglandins, including PGD2. The trial studying the metabolic pathway of PGD2 to 11-dehydro-thromboxane B2 aims to uncover additional metabolic routes that could influence inflammatory and thrombotic processes. Understanding these pathways is crucial for patients because it can lead to more targeted therapies that modulate specific prostaglandin metabolites, potentially improving the management of conditions associated with inflammation and thrombosis.