Inflammation and Daily Life Study

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-09

Study Completion Date

2024-06-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

UCLA researchers looking for healthy individuals (age 45-60) to participate in a study investigating whether an anti-inflammatory medication can impact daily life experiences.

Everyday for two weeks, participants will take either an anti-inflammatory medication (naproxen) twice daily, or a placebo pill twice daily. Participants will also answer daily questions during the 2-week period. Participants will also fill out questionnaires and complete a few tasks on the computer: once prior to the 2-week period and once immediately after the 2-week period, both during online study sessions.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Efficacy of Addition of Naproxen in the Treatment of Critically Ill Patients Hospitalized for COVID-19 Infection

NCT04325633

COVID-19

TERMINATED PHASE3

Assessing the Analgesic Efficacy of Naproxen Sodium in Postsurgical Dental Pain.

NCT00720057

Toothache

COMPLETED PHASE3

Open-Label, Placebo-Controlled, Parallel Group Study in Healthy Volunteers to Evaluate the Effects of Two Single MT 400 or Naproxen Sodium Tablets

NCT00596245

Healthy

COMPLETED PHASE1

PK,PD and DDI of Epaminurad and Naproxen in Healthy Volunteers

NCT06435442

Healthy

ENROLLING_BY_INVITATION PHASE1

Ibuprofen Versus Placebo For Muscle Soreness

NCT03228992

Muscle Soreness

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Participants (ntotal=50) will be men and women, ages 45-60. All interested participants will first complete a structured telephone interview in order to assess eligibility.

The study will begin with filling out questionnaires, as well as an online session to complete some tasks. You will then be randomly assigned to take either an anti-inflammatory medication (naproxen) or placebo (inactive substance) to take twice daily everyday for the following two weeks. You will also be contacted by text message to remind you to take your pills, to ask if you have taken your pills, and to send you a link to fill out questionnaires once daily. After the two weeks are over, you will again complete questionnaires and the online study session with tasks. Finally, two weeks after the second session, you will receive an email to fill out questionnaires online.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Inflammation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Naproxen

Group Type ACTIVE_COMPARATOR

Naproxen

Intervention Type DRUG

Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)

Placebo

Group Type PLACEBO_COMPARATOR

Placebos

Intervention Type DRUG

Half of the participants will be randomly assigned to receive a placebo pill twice daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Naproxen

Half of the participants will be randomly assigned to receive naproxen twice daily (400 mg total daily; 200 mg 2x a day)

Intervention Type DRUG

Placebos

Half of the participants will be randomly assigned to receive a placebo pill twice daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* healthy adults 45-60

Exclusion Criteria

* certain active, uncontrolled medical disorders
* use of certain medications (e.g., hypnotic and psychotropic medication, steroid use, opioid use)
* psychiatric disorders (e.g., current major depression, bipolar disorder)

Minimum Eligible Age

45 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes