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Last Updated: January 26, 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.
OTC NCT01427803 Actual Use Trial of Naproxen Sodium Completed Bayer Phase 3 2011-09-01 An actual use trial to demonstrate that consumers will not exceed the labeled daily dose of Aleve 24 Hour at an unacceptable rate. Two aspects of consumer use will be evaluated: 1) the frequency at which consumers exceed the label-defined daily dose, thus putting themselves at clinical risk, and 2) the reasons for exceeding the labeled daily dose.
OTC NCT02519231 Copper IUD Treatment Observation Study Recruiting Cook County Hospital Phase 4 2016-02-01 Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7 days of menstruation for three consecutive cycles, and then observed for one cycle without treatment.
OTC NCT02519231 Copper IUD Treatment Observation Study Recruiting Teva Pharmaceuticals USA Phase 4 2016-02-01 Studies indicate that bleeding irregularities and dysmenorrhea are common reasons for copper IUD method discontinuation. Some evidence suggests that non-steroidal anti-inflammatory medications (NSAIDs) can help improve bleeding during Cu-IUD use. However, these studies did not examine NSAID use with the TCu380A specifically, nor did they evaluate readily available NSAIDs such as over-the-counter naproxen. For this reason, the investigators propose a pilot trial in which new TCu380A users complaining of heavy or prolonged menstrual bleeding or spotting after 1 month of use are randomized to naproxen or placebo to be taken the first 7 days of menstruation for three consecutive cycles, and then observed for one cycle without treatment.
>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.
NCT00261586 A Safety Trial to Compare Different Analgesics in Combination With Low Dose Aspirin to Study Their Bleeding Properties and Their Effects on the Stomach Completed Johnson & Johnson Consumer and Personal Products Worldwide Phase 4 1969-12-31 The purpose of this study is to compare several analgesics given in approved daily doses in combination with a daily cardioprotective dose of aspirin (81 mg), to study their bleeding properties and their effects on the stomach in healthy volunteers.
NCT00329355 Menstrual Migraine Treatment With TREXIMET (Formerly Known as TREXIMA) Completed GlaxoSmithKline Phase 3 2006-05-01 This study was designed to determine efficacy of TREXIMET (sumatriptan/naproxen sodium), formerly known as TREXIMA compared to placebo for the treatment of a menstrual migraine.
NCT00329459 Treximet (Sumatriptan/Naproxen Sodium), Formerly Known as TREXIMA, for Menstrual Migraine in Women With Dysmenorrhea Completed GlaxoSmithKline Phase 3 2006-05-01 This study was designed to determine efficacy of TREXIMA compared to placebo for the treatment of a menstrual migraine.
>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 9
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 360
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 20
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 20
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 5
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Clinical Trial Sponsors for Naproxen Sodium

Sponsor Name

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

Sponsor Type for Naproxen Sodium
Sponsor Trials
Industry 66
Other 36
NIH 3
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