56 completed, 3 unknown, 3 withdrawn, 2 not yet recruiting. 66 Phase 3, 7 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 66 | Completed 56, Unknown 3, Withdrawn 3, Not yet recruiting 2, Enrolling by invitation 1, Terminated 1 |
| Phase 2 | 7 | Completed 6, Withdrawn 1 |
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 |
|---|---|---|---|---|---|---|
| Naproxen Versus Placebo as Adjunct Treatment of Cellulitis enteric-coated naproxen, Cephalexin Tablets, Placebo - Cellulitis, Skin Disease, Infectious | Phase 3 | Not yet recruiting | Ottawa Hospital Research Institute | 884 | 2026-11-01 | 2026-10-20 |
| An Artificial Intelligence Driven Approach to Optimize Patient Selection for a Transitional Pain Service TPS-Select, Pharmacologic Pain Management, Interventional Pain Procedures - Postsurgical Pain Management, Postsurgical Pain, Chronic | Phase 3 | Not yet recruiting | University of California, San Francisco | 474 | 2026-10-01 | 2026-10-09 |
| NSAIDS Following Elective Lumbar Spine Fusion Ketorolac, Naproxen, Standard Postoperative Pain Management - NSAID (Non-Steroidal Anti-Inflammatory Drug), Lumbar Spine Fusion | Phase 3 | Enrolling by invitation | Rothman Institute Orthopaedics | 428 | 2024-07-08 | 2026-08-04 |
| A Study of an Acetaminophen/Naproxen Sodium Fixed Combination, Acetaminophen and Naproxen Sodium in Postoperative Dental Pain Acetaminophen/Naproxen Sodium Fixed Combination, Naproxen Sodium, Acetaminophen - Pain | Phase 3 | Completed | Johnson & Johnson Consumer Inc. (J&JCI) | 447 | 2023-05-22 | 2026-11-03 |
| Effect of Preoperative Tramadol and Naproxen Sodium on Post Operative Pain Tramadol, Naproxen Sodium, Placebo - Symptomatic Irreversible Pulpitis, Post Operative Pain | Phase 2 / Phase 3 | Completed | Dow University of Health Sciences | 139 | 2023-03-01 | 2026-06-25 |
| Efficacy and Safety of Rizatriptan-Naproxen (10/550 mg) in the Acute Treatment of Migraine Rizatriptan 10 mg + Naproxen 550mg, Maxalt 10Mg Tablet, Flanax 550mg - Migraine | Phase 3 | Completed | Eurofarma Laboratorios S.A. | 2068 | 2022-12-30 | 2026-10-26 |
| Effect of Over-the-counter Analgesics on Postoperative Pain Naproxen, Acetaminophen (Standard of Care), ibuprofen - Pain Management | Phase 3 | Completed | Zitelli & Brodland Skin Cancer Center | 200 | 2022-12-22 | 2025-04-29 |
| A Study to Learn How Well a Single Dose of the Study Treatment Naproxen Sodium and Caffeine Combined in One Tablet (Fixed-dose Combination) Works to Relieve Pain After Dental Surgeries Compared to the Single Ingredients and to Placebo Naproxen sodium and caffeine (BAY2880376), Naproxen sodium (Aleve), Caffeine - Postoperative Dental Pain | Phase 3 | Completed | Bayer | 541 | 2022-09-21 | 2025-03-25 |
| Post Operative Pain Management Through Adductor Canal Block With Bupivacaine for ACL Reconstruction OxyCODONE 5 mg Oral Tablet, Naproxen 500 Mg, Tylenol Pill - Pain, Postoperative, ACL | Phase 3 | Unknown | Rothman Institute Orthopaedics | 154 | 2021-12-06 | 2021-12-17 |
| Pain Management After Surgery OxyCODONE 5 mg Oral Tablet, Acetaminophen 500Mg Tab, Naproxen 500 Mg - Pain, Postoperative | Phase 3 | Unknown | Rothman Institute Orthopaedics | 200 | 2021-11-30 | 2021-12-13 |
| Symptomatic Management of Lyme Arthritis Naproxen, Acetaminophen - Lyme Arthritis, Lyme Disease | Phase 3 | Terminated | Desiree Neville, MD | 3 | 2019-10-01 | 2025-11-17 |
| Study of Sumatriptan Naproxen Sodium Succinate Tablets for the Treatment of Acute Migraine Attacks sumatriptan 85mg and naproxen sodium 500mg, Placebo - Migraine in Adults | Phase 3 | Unknown | Peking University Third Hospital | 240 | 2018-08-01 | 2021-07-07 |
| A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip Fasinumab, Naproxen, Fasinumab-matching placebo - Osteoarthritis, Knee, Osteoarthritis, Hip | Phase 3 | Completed | Regeneron Pharmaceuticals | 3307 | 2017-08-17 | 2022-11-14 |
| Evaluation of Two Therapies for the Treatment of Osteoarticular Inflammation in Dyspeptic Patients Nimesulide + Pantoprazole, Naproxen + Esomeprazole - Acute and Chronic Inflammation, Dyspepsia | Phase 3 | Completed | EMS | 490 | 2016-02-17 | 2019-04-17 |
| Diazepam Use With Standard Management for Acute Low Back Pain Naproxen, Placebo, Diazepam - Low Back Pain | Phase 2 / Phase 3 | Completed | Montefiore Medical Center | 114 | 2015-06-01 | 2018-08-01 |
| Evaluation of Rebamipide and Rabeprazole Effect Associated or Not to Prevent Naproxen-induced Gastric Lesions 550 mg naproxen + 300 mg rebamipide + 20 mg rabeprazole., 550 mg naproxen + placebo + 20 mg rabeprazole, 550 mg naproxen + 300 mg rebamipide + placebo - Gastric Lesion | Phase 3 | Completed | Galeno Desenvolvimento de Pesquisas Clínicas | 32 | 2014-11-12 | 2018-09-05 |
| Efficacy and Safety of a Fixed-dose Combination of Naratriptan and Naproxen in Acute Treatment of Migraine. naratriptan + naproxen, naratriptan, naproxen - Migraine, Headache | Phase 3 | Withdrawn | Ache Laboratorios Farmaceuticos S.A. | 2014-07-01 | 2016-03-16 | |
| Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout Febuxostat IR, Febuxostat XR, Febuxostat placebo - Gout | Phase 3 | Completed | Takeda | 1790 | 2014-04-01 | 2016-11-03 |
| Paradoxical Tuberculosis Immune Reconstitution Inflammatory Syndrome (TB-IRIS) Treatment Trial Dexamethasone, Atorvastatin, Naproxen - Immune Reconstitution Inflammatory Syndrome, Immune Reconstitution Syndrome | Phase 2 / Phase 3 | Withdrawn | University of Minnesota | 2014-01-01 | 2013-11-25 | |
| Characterize Flu-like Symptoms in Relapsing Multiple Sclerosis Patients Transitioning From Non-Pegylated Interferon Beta (IFN-β) Therapies to Peginterferon Beta-1a (BIIB017) BIIB017, naproxen - Relapsing Multiple Sclerosis | Phase 3 | Completed | Biogen | 251 | 2013-11-01 | 2017-01-25 |
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Migraine Disorders (17) · Osteoarthritis (12) · Pain, Postoperative (8) · Arthritis (6) · Stomach Ulcer (6) · Headache (5) · Pain (5) · Osteoarthritis, Hip (4) · Osteoarthritis, Knee (4) · Dysmenorrhea (3) · Toothache (3) · Alzheimer Disease (2) · Arthritis, Juvenile (2) · Arthritis, Rheumatoid (2) · Back Pain (2)
GlaxoSmithKline (10) · POZEN (7) · Bayer (5) · Pfizer (5) · EMS (3) · NicOx (3) · Rothman Institute Orthopaedics (3) · Ache Laboratorios Farmaceuticos S.A. (2) · Takeda (2) · Biogen (1) · Boehringer Ingelheim (1) · Chinese University of Hong Kong (1) · Desiree Neville, MD (1) · Dow University of Health Sciences (1) · Eurofarma Laboratorios S.A. (1)
United States (43) · Brazil (5) · Canada (4) · Germany (3) · Russia (3) · Belgium (2) · China (2) · Denmark (2) · France (2) · Spain (2) · Thailand (2) · United Kingdom (2) · Austria (1) · Hungary (1) · Italy (1)
David Taylor (3) · Everardus Orlemans, PhD (3) · Andrew Bishara, MD (1) · Andrew Hershey, MD (1) · David R Boulware, MD, MPH (1) · Desiree NW Neville, MD (1) · Deusvenir S Carvalho (1) · Donald W Lewis, MD (1)
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2008 (1), 2014 (1), 2016 (1), U01AG015477 (1), U10CA037420 (1), U10EY017281 (1), U10EY017387 (1)