57 completed, 4 terminated, 3 unknown, 1 not yet recruiting. 66 Phase 1, 4 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 66 | Completed 57, Terminated 4, Unknown 3, Not yet recruiting 1, Recruiting 1 |
| Phase 2 | 4 | Completed 4 |
Follow Naproxen: new trials by email Literature Review of Naproxen trials Research Report on Naproxen
Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Safety and Tolerability of Metformin and Naproxen for Cancer Prevention in Fanconi Anemia Metformin, Naproxen Sodium - Fanconi Anemia, Head and Neck Cancer | Phase 1 | Recruiting | Rockefeller University | 80 | 2026-10-14 | 2026-10-28 |
| A Study to Evaluate the Pharmacokinetics and Food-effect of IN-M00002 Tablet in Healthy Adult Volunteers Tegoprazan, Naproxen, IN-M00002 - Healthy Volunteer | Phase 1 | Not yet recruiting | HK inno.N Corporation | 74 | 2025-12-27 | 2025-12-11 |
| A Study to Learn About Whether BAYH006689 Causes Skin Irritation When Applied as a Topical Gel in Healthy Participants Naproxen (BAYH006689), Placebo Gel, A solution of 0.9% Saline - Pain, Healthy Volunteers | Phase 1 | Completed | Bayer | 42 | 2024-07-23 | 2024-09-19 |
| A Study to Learn About Whether BAY H006689 Causes an Allergic Reaction When Applied as a Topical Gel in Healthy Participants Naproxen (BAYH006689), Placebo Gel, A solution of 0.9% Saline - Pain, Healthy Volunteers | Phase 1 | Completed | Bayer | 236 | 2024-06-05 | 2024-08-14 |
| PK,PD and DDI of Epaminurad and Naproxen in Healthy Volunteers Epaminurad, Naproxen, Epaminurad, Epaminurad placebo - Healthy | Phase 1 | Completed | JW Pharmaceutical | 57 | 2024-06-03 | 2026-04-16 |
| A Study of Acetaminophen/Naproxen Sodium Fixed Combination Tablets in Adolescents 12 to <17 Years of Age With Pain Acetaminophen/Naproxen Sodium - Orthodontic Pain | Phase 1 | Completed | Johnson & Johnson Consumer Inc. (J&JCI) | 24 | 2023-09-13 | 2024-03-15 |
| Study to Evaluate Pharmacokinetic Drug Interactions and Safety of Naproxen, Aceclofenac, Celecoxib and Ilaprazole Ilaprazole, Naproxen, Aceclofenac - Drug Interaction Potentiation | Phase 1 | Completed | Il-Yang Pharm. Co., Ltd. | 72 | 2022-02-17 | 2023-06-28 |
| Compare Pharmacokinetics and Safety of JP-1366 Between Korean and Caucasian coadministration of JP-1366 and aceclofenac, coadministration of JP-1366 and meloxicam, coadministration of JP-1366 and naproxen - Anti-Ulcer Agents | Phase 1 | Completed | Onconic Therapeutics Inc. | 88 | 2021-03-05 | 2022-06-30 |
| Drug-drug Interaction Between DWP14012 and Three Different Kinds of NSAIDs DWP14012, Celecoxib, Naproxen - Healthy Male Volunteers | Phase 1 | Unknown | Daewoong Pharmaceutical Co. LTD. | 110 | 2020-06-19 | 2020-07-29 |
| Pharmacokinetic Interaction Between Tegoprazan and NSAIDs After Multiple Oral Dosing in Healthy Male Volunteers Tegoprazan, Naproxen, Aceclofenac - Healthy | Phase 1 | Completed | HK inno.N Corporation | 60 | 2020-06-06 | 2020-11-23 |
| The Effect of Naproxen on the Pharmacokinetic Profile of LC350189 in Healthy Adults Xanthine Oxidase Inhibitor, nonsteroidal anti-inflammatory drug - Gout, Hyperuricemia | Phase 1 | Completed | LG Chem | 24 | 2020-01-22 | 2020-06-26 |
| A Study to Assess Bioquivalence Between a Novel Naproxen Sodium 275 mg Film-coated Tablet and Nalgesin Naproxen Sodium 275 mg Film-coated Tablet in Healthy Adult Volunteers Naproxen sodium (test product), Naproxen sodium (reference product) - Healthy | Phase 1 | Completed | McNeil AB | 28 | 2018-12-03 | 2020-01-23 |
| Phase I/II Study of Immunotherapy Combination BN-Brachyury Vaccine, M7824, N-803 and Epacadostat (QuEST1) M7824, N-803, MVA-BN-Brachyury - Metastatic Castration-resistant Prostate Cancer, Prostate Cancer | Phase 1 / Phase 2 | Completed | National Cancer Institute (NCI) | 59 | 2018-05-01 | 2025-09-30 |
| A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Under Fed Conditions Naproxen sodium and diphenhydramine hydrochloride soft capsules, Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve PM, BAY98-7111) - Clinical Pharmacology | Phase 1 | Completed | Bayer | 60 | 2018-03-02 | 2019-03-20 |
| A Pharmacokinetic Trial of Naproxen Sodium and Diphenhydramine Hydrochloride Soft Capsules Versus Naproxen Sodium and Diphenhydramine Hydrochloride Tablets in Healthy Adult Subjects Naproxen sodium and diphenhydramine hydrochloride soft capsules, Naproxen sodium and diphenhydramine hydrochloride coated tablets (Aleve, PMBAY98-7111) - Pain | Phase 1 | Completed | Bayer | 36 | 2018-02-12 | 2019-03-20 |
| To Compare the Gastrointestinal Safety of a 14-Day Oral Dosing Regimen of ATB-346 to Sodium Naproxen in Healthy Subjects ATB-346 OR Placebo, Naproxen sodium - Gastric Ulcer | Phase 1 / Phase 2 | Completed | Antibe Therapeutics Inc. | 258 | 2017-09-08 | 2018-06-06 |
| Study to Evaluate the Pharmacokinetics and Pharmacodynamics of JMI-001 JMI-001, Naproxen, Fexofenadine - Veisalgia | Phase 1 | Unknown | Sen-Jam Pharmaceutical | 48 | 2017-08-01 | 2017-06-12 |
| Variability in Response to Non-steroidal Anti-inflammatory Drugs Celecoxib, Naproxen, Placebo - Healthy | Phase 1 | Terminated | University of Pennsylvania | 16 | 2015-11-01 | 2023-12-13 |
| Pilot Study of OXP005 to Assess Gastroduodenal Irritation OXP005, Naproxen - Gastroduodenal Erosions | Phase 1 | Completed | Oxford Pharmascience Ltd | 2015-05-01 | 2015-06-18 | |
| Naproxen Sodium/ASA Platelet Study Naproxen Sodium (Aleve, BAY117031), Acetylsalicylic Acid (Aspirin, BAYE4465) - Hematology | Phase 1 | Completed | Bayer | 117 | 2015-02-01 | 2016-07-15 |
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Pain (6) · Osteoarthritis (5) · Arthritis (3) · Gout (2) · Hypertension (2) · Osteoarthritis, Knee (2) · Acute Pain (1) · Agnosia (1) · Arthritis, Juvenile (1) · Arthritis, Rheumatoid (1) · Carcinoma, Squamous Cell (1) · Colorectal Neoplasms, Hereditary Nonpolyposis (1) · Fanconi Anemia (1) · Head and Neck Neoplasms (1) · Hyperuricemia (1)
Bayer (11) · AstraZeneca (5) · Dr. Reddy's Laboratories Limited (4) · NicOx (4) · POZEN (3) · HK inno.N Corporation (2) · Merck Sharp & Dohme LLC (2) · National Cancer Institute (NCI) (2) · Oxford Pharmascience Ltd (2) · Perrigo Company (2) · Pfizer (2) · University of Pennsylvania (2) · Antibe Therapeutics Inc. (1) · Ardea Biosciences, Inc. (1) · Astellas Pharma Europe B.V. (1)
United States (28) · South Korea (7) · India (4) · United Kingdom (4) · Sweden (2) · Australia (1) · Belgium (1) · Canada (1) · France (1) · Germany (1) · Iran (1) · Russia (1) · South Africa (1) · Switzerland (1)
Dr. Umesh Dhakate, MBBS (2) · Garret A FitzGerald, MD (2) · Mark Sostek, MD (2) · Sandhya Ravi, MBBS, MS. (2) · Agata Smogorzewska, MD, PhD (1) · Antonio Rusca, MD FMH (1) · Aslak Rautio, MD (1) · Bo Fransson (1) · Carsten C Skarke, MD (1) · Carsten Skarke, MD (1)
PMID 20175977, PMID 20804454, PMID 21052881, PMID 22278334, PMID 27121942, PMID 27259970, PMID 29198079, PMID 30227893, PMID 32641470, PMID 33602696, PMID 35787943, PMID 38700290, PMID 38854091, PMID 41459594, PMID 42498485
2009 (1), 2014 (1), N01CN00034 (1), P30CA016672 (1), U54HL117798 (1)