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Last Updated: October 7, 2022

CLINICAL TRIALS PROFILE FOR NAPROXEN


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505(b)(2) Clinical Trials for NAPROXEN

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00410995 ↗ Effects of Naproxen on Physical Performance Terminated University of Oklahoma Phase 4 2004-05-01 The purpose of this study is to determine the effect of daily use of Naproxen (a commonly used over-the-counter NSAID) on the physical performance of athletes, as measured by maximum oxygen consumption.
OTC NCT00751400 ↗ Naproxen Sodium Extended-Release Actual Use Study Completed Pegus Research, Inc. Phase 3 2008-07-01 The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.
OTC NCT00751400 ↗ Naproxen Sodium Extended-Release Actual Use Study Completed Bayer Phase 3 2008-07-01 The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.
New Formulation NCT00945178 ↗ Double-blind Placebo-controlled 2-part Study Assessing the Safety, Tolerability and PK of AZD1386 in Healthy Volunteers Terminated AstraZeneca Phase 1 2009-08-01 The study will investigate how a new formulation of the study drug is absorbed, metabolised and distributed through the body, as well as its safety and tolerability in higher doses when given as single and multiple doses and as a single dose in the presence and absence of naproxen.
OTC NCT01365052 ↗ Safety Trial of Naproxen Sodium/ Diphenhydramine Completed Bayer Phase 3 2011-05-01 The purpose of this trial is to see how safe the combination of naproxen sodium 440 mg and diphenhydramine hydrochloride (DPH) 50 mg (the investigational product) is compared to placebo (capsules containing no drug) when taken for 10 days.
OTC NCT01383486 ↗ Self Selection Trial of Naproxen Sodium Completed Bayer Phase 3 2011-07-01 A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their own use based on expected duration of pain greater than 12 hours.
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for NAPROXEN

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00001955 ↗ Study of Etanercept and Celecoxib to Treat Temporomandibular Disorders (Painful Joint Conditions) Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 1999-12-01 This 2-part study will evaluate the effectiveness and side effects of two anti-inflammatory drugs for relieving pain and improving jaw function in patients with temporomandibular disorder (TMD). Part 1 will evaluate celecoxib (Celebrex); Part 2 will evaluate etanercept (Enbrel). The Food and Drug Administration has approved both of these drugs for treating certain forms of arthritis. Patients between the ages of 18 and 65 years with painful jaw joint conditions may be eligible for this study. Candidates will complete several written questionnaires about their jaw condition and will undergo a medical history, complete TMD evaluation, blood and urine tests, and imaging studies of the temporomandibular joint, such as X-rays and magnetic resonance imaging. Patients will rate the quality and intensity of their pain before beginning treatment. At certain periods during the study, they will also keep a pain diary, twice a day recording the intensity and magnitude of their pain. Part 1 - Celecoxib: Patients will be randomly assigned to receive either 1) celecoxib twice a day by mouth; 2) naproxen (a non-steroidal anti-inflammatory drug) twice a day by mouth; or 3) a placebo (inactive pill) twice a day by mouth. Part 2 - Etanercept: Patients will be randomly assigned to receive either 1) etanercept injected under the skin or 2) saline (an inactive placebo) injected under the skin. Patients in this group will also undergo two aspirations of fluid from the jaw joint - once before treatment begins and again 6 weeks later. For this procedure, the joint is numbed with an anesthetic and then a needle is inserted into the jaw space to withdraw fluid, which will be analyzed for inflammatory processes in the joint. All patients will have a final evaluation 6 weeks after beginning treatment, including a TMD physical examination, laboratory and X-ray tests as required. The pain diary and questionnaires will be collected at this visit.
NCT00004845 ↗ A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study) Completed Alzheimer's Disease Cooperative Study (ADCS) Phase 2/Phase 3 1969-12-31 The primary specific aim of this clinical trial is to determine whether treatment with rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in patients with Alzheimer's disease (AD) as measured by ADAScog.
NCT00004845 ↗ A Multicenter Trial of Rofecoxib and Naproxen in Alzheimer's Disease (NSAID Study) Completed National Institute on Aging (NIA) Phase 2/Phase 3 1969-12-31 The primary specific aim of this clinical trial is to determine whether treatment with rofecoxib or naproxen for one year will slow the rate of decline of cognitive function in patients with Alzheimer's disease (AD) as measured by ADAScog.
NCT00007189 ↗ Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT) Completed Johns Hopkins University Phase 3 2001-01-01 The purpose of this trial is to test the ability of the non-steroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of AD and age-related cognitive decline.
NCT00007189 ↗ Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT) Completed National Institute on Aging (NIA) Phase 3 2001-01-01 The purpose of this trial is to test the ability of the non-steroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of AD and age-related cognitive decline.
NCT00007189 ↗ Alzheimer's Disease Anti-Inflammatory Prevention Trial (ADAPT) Completed University of Washington Phase 3 2001-01-01 The purpose of this trial is to test the ability of the non-steroidal anti-inflammatory medications naproxen and celecoxib to delay or prevent the onset of AD and age-related cognitive decline.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for NAPROXEN

Condition Name

Condition Name for NAPROXEN
Intervention Trials
Osteoarthritis 29
Pain 26
Healthy 22
Migraine Disorders 18
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Condition MeSH

Condition MeSH for NAPROXEN
Intervention Trials
Osteoarthritis 52
Migraine Disorders 37
Osteoarthritis, Knee 33
Arthritis 19
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Clinical Trial Locations for NAPROXEN

Trials by Country

Trials by Country for NAPROXEN
Location Trials
Canada 51
United Kingdom 34
Brazil 24
Poland 17
Mexico 15
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Trials by US State

Trials by US State for NAPROXEN
Location Trials
Texas 77
Florida 60
California 60
New York 54
Illinois 49
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Clinical Trial Progress for NAPROXEN

Clinical Trial Phase

Clinical Trial Phase for NAPROXEN
Clinical Trial Phase Trials
Phase 4 79
Phase 3 69
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for NAPROXEN
Clinical Trial Phase Trials
Completed 243
Terminated 17
Unknown status 15
[disabled in preview] 33
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Clinical Trial Sponsors for NAPROXEN

Sponsor Name

Sponsor Name for NAPROXEN
Sponsor Trials
GlaxoSmithKline 27
Bayer 26
Pfizer 25
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Sponsor Type

Sponsor Type for NAPROXEN
Sponsor Trials
Industry 209
Other 189
NIH 26
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Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
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Dow
AstraZeneca
Moodys

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