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Anti-inflammatory Drug

Diclofenac + Curcumin for Drug Interactions

Q: Are elderly individuals eligible for recruitment in this research endeavor?

This study has set an age range of 18-65 for potential participants.

Q: Does my profile qualify me for enrollment in this research endeavor?

To be eligible for this investigation, hopeful participants must lie between the ages of 18 and 65. At present, roughly 30 individuals have been accepted into the trial.

Q: Are there still vacancies in this clinical trial?

Reported on clinicaltrials.gov, this particular trial is not currently open for recruitment; though it saw its first listing posted on November 1st 2023 and was last edited on September 22nd 2023. Fortunately, there are some other studies which are actively soliciting patients at the present time.

Phase < 1

Waitlist Available

Research Sponsored by Washington State University

Eligibility Criteria Checklist

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

Must have

Not taking any medications (prescription and non-prescription) or dietary/herbal supplements known to alter the pharmacokinetics of diclofenac or curcumin

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 0-12 hours

Awards & highlights

Study Summary

This trial studies how a drug-metabolizing enzyme & an herbal product affect a widely-used medication. Results will inform future studies on drug effects & risk of toxicity.

Who is the study for?

This trial is for healthy adults aged 18-64 who don't have major illnesses like kidney or liver disease, diabetes, heart conditions, or cancer. Participants must not be on medications that affect diclofenac or curcumin and should avoid caffeine and alcohol before study days. They can't smoke, use cannabis products, be pregnant/nursing, or planning pregnancy soon after the trial.Check my eligibility

What is being tested?

The study is testing how a natural product called curcumin affects the breakdown of diclofenac—a common pain reliever—by inhibiting an enzyme known as UGT2B17. This pilot study will help design future research on genetic differences in drug metabolism and potential toxicity risks.See study design

What are the potential side effects?

Possible side effects may include digestive issues due to diclofenac such as stomach pain, nausea, and increased risk of bleeding. Curcumin might cause mild symptoms like bloating or allergic reactions in sensitive individuals.

Eligibility Criteria

Inclusion Criteria

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

Select...

I am not on medications or supplements that affect diclofenac or curcumin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 0-12 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~0-12 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-12 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Diclofenac AUC in EMs in the presence of curcumin

Diclofenac AUC in poor metabolizers (PMs)

Diclofenac CLr in EMs in the presence of curcumin

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm 2: diclofenac + curcuminExperimental Treatment2 Interventions

A single oral dose of diclofenac (25 mg capsule) and a single oral dose of curcumin (2,000 mg tablet) will be administered by mouth to the 5 participants genotyped as extensive metabolizers. Plasma and urine will be collected from 0-12 hours.

Group II: Arm 1: diclofenac alone (baseline)Experimental Treatment1 Intervention

A single dose of diclofenac (25 mg capsule) will be administered by mouth to 5 participants (minimum 2 females) genotyped as extensive metabolizers (Arm 1A) and 5 participants (minimum 2 females) genotyped as poor metabolizers (Arm 1B). Plasma and urine will be collected from 0-12 hours. A washout of at least 3 days will elapse between Arm 1 and Arm 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Diclofenac

2014

Completed Phase 4

~13430

curcumin

2017

Completed Phase 4

~1120

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Washington State UniversityLead Sponsor

101 Previous Clinical Trials

56,684 Total Patients Enrolled

1 Trials studying Interactions

32 Patients Enrolled for Interactions

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are elderly individuals eligible for recruitment in this research endeavor?

"This study has set an age range of 18-65 for potential participants."

Answered by AI

Does my profile qualify me for enrollment in this research endeavor?

"To be eligible for this investigation, hopeful participants must lie between the ages of 18 and 65. At present, roughly 30 individuals have been accepted into the trial."

Answered by AI

Are there still vacancies in this clinical trial?

"Reported on clinicaltrials.gov, this particular trial is not currently open for recruitment; though it saw its first listing posted on November 1st 2023 and was last edited on September 22nd 2023. Fortunately, there are some other studies which are actively soliciting patients at the present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Contribution of UGT2B17 to the Pharmacokinetics of Diclofenac

Mary Paine 2024. "Contribution of UGT2B17 to the Pharmacokinetics of Diclofenac". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06053411.