CLINICAL TRIALS PROFILE FOR DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
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505(b)(2) Clinical Trials for diphenhydramine hydrochloride; naproxen sodium
| Trial Type | Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|---|
| 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. |
| >Trial Type | >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for diphenhydramine hydrochloride; naproxen sodium
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01118273 ↗ | Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine | Completed | Bayer | Phase 4 | 2008-01-01 | The objectives of the study are to evaluate the analgesic and hypnotic efficacy of naproxen sodium and diphenhydramine combination when compared to naproxen sodium, diphenhydramine, and an ibuprofen and diphenhydramine combination |
| NCT01280591 ↗ | Evaluate Analgesic/Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain | Completed | Bayer | Phase 3 | 2010-10-01 | The objective of the study is to evaluate the efficacy and safety of a single oral dose of two dose combinations of naproxen sodium and diphenhydramine (DPH) to demonstrate that naproxen sodium/DPH combination provides added clinical benefit to sleep improvement than either single ingredient alone in subjects with post-surgical dental pain and phase advanced sleep. |
| 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. |
| NCT01495858 ↗ | Evaluate Analgesic / Sedative Efficacy of Naproxen Sodium and Diphenhydramine in Patients With Postsurgical Dental Pain | Completed | Bayer | Phase 3 | 2011-12-01 | The objective of the study is to evaluate the efficacy and safety of a single oral dose of naproxen sodium 440 mg in combination with DPH (diphenhydramine) 25 mg in subjects with postsurgical dental pain and phase advanced sleep. |
| NCT01666678 ↗ | Compare Pharmacokinetic (PK) Profiles of Naproxen Sodium, Diphenhydramine Hydrochloride, and Naproxen Sodium and Diphenhydramine Hydrochloride Combination | Completed | Bayer | Phase 1 | 2012-01-01 | The purpose of the current trial is to evaluate the bioavailability of a single oral dose of naproxen sodium 440 mg and DPH HCL 50 mg under fasting and fed conditions and currently marketed single ingredient products containing naproxen sodium (2 x Aleve® 220 mg tablets) or DPH HCL (2 Allergy Relief x 25 mg tablets) under fasting conditions. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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