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Last Updated: May 29, 2020

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CLINICAL TRIALS PROFILE FOR NAPROXEN SODIUM

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505(b)(2) Clinical Trials for Naproxen Sodium

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 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.
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 Sodium

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00092729 An Investigational Drug Study in the Treatment of Primary Dysmenorrhea (0663-064) Completed Merck Sharp & Dohme Corp. Phase 3 2002-06-01 The purpose of this study is to evaluate the pain relieving effect and safety of an investigational drug in women with moderate to severe primary dysmenorrhea (painful menstruation).
NCT00114049 Dental Pain (Following Third Molar Tooth Extraction) Study Completed GlaxoSmithKline Phase 3 2004-12-01 The purpose of this study is to evaluate the effectiveness of GW406381 (a COX-2 inhibitor) in treating the signs and symptoms of dental pain following third molar tooth extraction.
NCT00240617 Study Of Treximet, Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks Completed GlaxoSmithKline Phase 3 2005-10-01 The purpose of this study is to determine the consistency of response for Treximet (formerly known as Trexima) when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.
NCT00240630 Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as Trexima, In The Acute Treatment Of Multiple Migraine Attacks Completed GlaxoSmithKline Phase 3 2005-10-01 The purpose of this study is to determine the consistency of response for Treximet (sumatriptan/naproxen sodium), formerly known as Trexima, when treating four acute migraine attacks at the mild pain phase and within 1 hour of onset of head pain.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Naproxen Sodium

Condition Name

Condition Name for Naproxen Sodium
Intervention Trials
Migraine Disorders 16
Healthy 11
Pain 10
Migraine 6
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Condition MeSH

Condition MeSH for Naproxen Sodium
Intervention Trials
Migraine Disorders 25
Pain, Postoperative 6
Toothache 6
Dysmenorrhea 4
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Clinical Trial Locations for Naproxen Sodium

Trials by Country

Trials by Country for Naproxen Sodium
Location Trials
United States 361
India 4
Canada 3
Brazil 2
Turkey 2
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Trials by US State

Trials by US State for Naproxen Sodium
Location Trials
Texas 26
Utah 21
California 16
Florida 15
Ohio 14
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Clinical Trial Progress for Naproxen Sodium

Clinical Trial Phase

Clinical Trial Phase for Naproxen Sodium
Clinical Trial Phase Trials
Phase 4 21
Phase 3 24
Phase 2/Phase 3 2
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Clinical Trial Status

Clinical Trial Status for Naproxen Sodium
Clinical Trial Phase Trials
Completed 66
Recruiting 9
Not yet recruiting 6
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Clinical Trial Sponsors for Naproxen Sodium

Sponsor Name

Sponsor Name for Naproxen Sodium
Sponsor Trials
Bayer 22
GlaxoSmithKline 21
Dr. Reddy's Laboratories Limited 4
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Sponsor Type

Sponsor Type for Naproxen Sodium
Sponsor Trials
Industry 67
Other 36
NIH 3
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