CLINICAL TRIALS PROFILE FOR NAPROXEN SODIUM
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505(b)(2) Clinical Trials for naproxen sodium
| 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 | Completed | 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. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >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 | 2002-06-07 | 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. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for naproxen sodium
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Clinical Trial Locations for naproxen sodium
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Clinical Trial Progress for naproxen sodium
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Clinical Trial Sponsors for naproxen sodium
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