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Last Updated: November 13, 2019

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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.
>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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Naproxen

Condition Name

Condition Name for Naproxen
Intervention Trials
Osteoarthritis 29
Healthy 20
Pain 19
Migraine Disorders 18
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Condition MeSH

Condition MeSH for Naproxen
Intervention Trials
Osteoarthritis 49
Migraine Disorders 34
Osteoarthritis, Knee 29
Back Pain 16
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Clinical Trial Locations for Naproxen

Trials by Country

Trials by Country for Naproxen
Location Trials
Canada 46
United Kingdom 25
Brazil 23
Mexico 14
Germany 10
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Trials by US State

Trials by US State for Naproxen
Location Trials
Texas 69
California 57
Florida 54
New York 48
Pennsylvania 44
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Clinical Trial Progress for Naproxen

Clinical Trial Phase

Clinical Trial Phase for Naproxen
Clinical Trial Phase Trials
Phase 4 65
Phase 3 63
Phase 2/Phase 3 5
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Clinical Trial Status

Clinical Trial Status for Naproxen
Clinical Trial Phase Trials
Completed 193
Recruiting 30
Terminated 12
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Clinical Trial Sponsors for Naproxen

Sponsor Name

Sponsor Name for Naproxen
Sponsor Trials
GlaxoSmithKline 27
Pfizer 22
Bayer 20
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Sponsor Type

Sponsor Type for Naproxen
Sponsor Trials
Industry 179
Other 142
NIH 19
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