CLINICAL TRIALS PROFILE FOR NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE

505(b)(2) Clinical Trials for NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE

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	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.

All Clinical Trials for NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE

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.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Alphacait, LLC	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.
NCT03299452 ↗	Clinical Studies by Using Alphacait to Screen Drugs for Advanced Solid Tumor	Unknown status	Haining Health-Coming Biotech Co., Ltd.	Phase 2	2017-01-01	This is a single-center, open-label, single-arm, non-randomized study designed to evaluate PFS, safety, overall survival (OS), objective response rate (OPR), disease control rate (DCR) and biomarkers of cancer therapy based on Alphacait screening system in subjects with advanced malignant tumor.

Clinical Trial Conditions for NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE

Condition Name

Condition Name for NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
Intervention	Trials
Pain	3
Pain, Postoperative	2
Anesthesia	1
Cesarean Section	1

Condition MeSH

Condition MeSH for NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
Intervention	Trials
Pain, Postoperative	3
Toothache	2
Malnutrition	1
Neoplasm Metastasis	1

Clinical Trial Locations for NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE

Trials by Country

Trials by Country for NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
Location	Trials
United States	19
Canada	1
China	1

Trials by US State

Trials by US State for NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
Location	Trials
Texas	5
Utah	4
Louisiana	1
Georgia	1
Florida	1

Clinical Trial Progress for NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	3
Phase 2	1

Clinical Trial Status

Clinical Trial Status for NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	7
Not yet recruiting	1
Unknown status	1

Clinical Trial Sponsors for NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
Sponsor	Trials
Bayer	7
Alphacait, LLC	1
Haining Health-Coming Biotech Co., Ltd.	1

Sponsor Type

Sponsor Type for NAPROXEN SODIUM AND DIPHENHYDRAMINE HYDROCHLORIDE
Sponsor	Trials
Industry	7
Other	3