39 completed, 7 terminated, 3 withdrawn, 1 active not recruiting. 53 Phase 2, 7 Phase 3, 4 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 53 | Completed 39, Terminated 7, Withdrawn 3, Active not recruiting 1, Not yet recruiting 1, Recruiting 1, Unknown 1 |
| Phase 3 | 7 | Completed 6, Withdrawn 1 |
| Phase 1 | 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 |
|---|---|---|---|---|---|---|
| Non Steroidal Anti-inflammatory Drugs in the Prevention of Bone Pain Flares After Palliative Radiotherapy Naproxen (Proxen S), Placebo, Esomeprazole 20mg once daily - Bone Pain Flare, Bone Metastasis | Phase 2 | Not yet recruiting | American University of Beirut Medical Center | 385 | 2025-04-01 | 2025-04-04 |
| A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome Naproxen, Aspirin - T Cells, Colorectal Cancer | Phase 2 | Recruiting | M.D. Anderson Cancer Center | 40 | 2023-03-21 | 2026-11-05 |
| 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 |
| Novel Non-opioid Post-surgical Pain Treatment in Females Carbidopa-Levodopa (100mg/25mg):, Naproxen - Acute Pain, Bunionectomy | Phase 2 | Withdrawn | Northwestern University | 2021-11-01 | 2024-03-18 | |
| Efficacy and Safety of Etoricoxib-tramadol Tablet in Acute Postoperative Pain etoricoxib-tramadol, Naproxen, Tramadol - Acute Pain, Postoperative Pain | Phase 2 | Completed | Laboratorios Liomont | 58 | 2021-09-29 | 2024-10-10 |
| Project 1 Aim 2, Adaptations of the Brain in Chronic Pain With Opioid Exposure Carbidopa-Levodopa 25 Mg-100 Mg Oral Tablet, Naproxen 500 Mg, Opioids - Opioid Use, Opioid Dependence | Phase 2 | Active not recruiting | Northwestern University | 60 | 2021-01-01 | 2024-11-27 |
| Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials Celecoxib, Naproxen, Meloxicam - Axial Spondyloarthritis | Phase 2 | Terminated | The University of Texas Health Science Center, Houston | 42 | 2020-06-25 | 2025-08-13 |
| Study to Find Out the Optimal Dose of Caffeine in the Combination Tablet of Naproxen Sodium and Caffeine in Patients Experiencing Moderate to Severe Pain After Having Wisdom Teeth Removed Naproxen sodium/Caffeine (BAY2880376), Naproxen sodium (Aleve), Caffeine - Pain, Postoperative | Phase 2 | Completed | Bayer | 193 | 2019-11-12 | 2021-09-01 |
| Naproxen Sodium/Acetaminophen Proof of Concept Dosing Study 440 mg naproxen sodium with 1000 mg acetaminophen, 220 mg naproxen sodium with 650 mg acetaminophen, 10 mg hydrocodone + 650 mg acetaminophen - Pain | Phase 2 | Completed | Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division | 290 | 2019-05-28 | 2022-12-05 |
| Study to Evaluate Arthroplasty Specimens for Osteoarthritis of the Knee and Hip Fasinumab, Naproxen, Diclofenac - Osteoarthritis, Knee, Osteoarthritis, Hip | Phase 2 | Terminated | Regeneron Pharmaceuticals | 23 | 2019-04-08 | 2023-10-17 |
| A Study to Evaluate the Efficacy and Safety of Gefapixant (MK-7264) in Women With Endometriosis-Related Pain (MK-7264-034) Gefapixant, Placebo, Naproxen - Endometriosis-related Pain | Phase 2 | Completed | Merck Sharp & Dohme LLC | 187 | 2018-09-11 | 2024-11-04 |
| A Pilot Study Assessing the Treatment Responsiveness of a Novel Osteoarthritis Stiffness Scale Naproxen Sodium (Aleve, BAY117031), Acetaminophen ER, Celecoxib - Osteoarthritis, Knee | Phase 2 | Completed | Bayer | 41 | 2018-06-29 | 2020-06-19 |
| 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 |
| 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 |
| A Study to Evaluate the Analgesic Efficacy and Safety of V120083 in Subjects With Osteoarthritis (OA) of the Knee V120083, Naproxen, Placebo - Osteo Arthritis Knee | Phase 2 | Completed | Purdue Pharma LP | 291 | 2017-03-14 | 2019-02-12 |
| A Study to Evaluate the Analgesic Efficacy and Safety of VM902A in Subjects With Osteoarthritis (OA) of the Knee VM902A 200-mg Capsules, VM902A 400-mg Capsules, Naproxen 500-mg Capsules - Osteoarthritis Pain of the Knee | Phase 2 | Terminated | Purdue Pharma LP | 75 | 2016-08-01 | 2017-11-22 |
| A Proof-of-Concept Study Assessing NEO6860 in Osteoarthritis Pain NEO6860, NEO6860 placebo, Naproxen - Pain, Osteoarthritis of the Knee | Phase 2 | Completed | Neomed Institute | 54 | 2016-03-01 | 2017-03-13 |
| A Study to Assess the Analgesic Efficacy of ASP7962 in Patients With Pain Due to Osteoarthritis of the Knee ASP7962, Naproxen, Placebo - Osteoarthritis of the Knee, Chronic Lower Back Pain | Phase 2 | Completed | Astellas Pharma Europe B.V. | 215 | 2016-02-16 | 2024-10-31 |
| 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 |
| PF-06372865 In Subjects With Chronic Low Back Pain PF-06372865, Placebo, Naproxen - Chronic Low Back Pain | Phase 2 | Completed | Pfizer | 302 | 2014-10-01 | 2017-01-04 |
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Pain (12) · Osteoarthritis, Knee (11) · Osteoarthritis (10) · Acute Pain (3) · Agnosia (3) · Low Back Pain (3) · Pain, Postoperative (3) · Toothache (3) · Alzheimer Disease (2) · Prostatic Neoplasms (2) · Stomach Ulcer (2) · Acquired Immunodeficiency Syndrome (1) · Arthritis (1) · Arthritis, Rheumatoid (1) · Axial Spondyloarthritis (1)
Pfizer (8) · Northwestern University (3) · Purdue Pharma LP (3) · AstraZeneca (2) · Bayer (2) · PLx Pharma (2) · AbbVie (prior sponsor, Abbott) (1) · American University of Beirut Medical Center (1) · Amgen (1) · Antibe Therapeutics Inc. (1) · Astellas Pharma Europe B.V. (1) · Azad University of Medical Sciences (1) · Boehringer Ingelheim (1) · Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) (1) · Douglas Mental Health University Institute (1)
United States (39) · Canada (8) · United Kingdom (3) · Australia (2) · Chile (2) · Germany (2) · Poland (2) · Puerto Rico (2) · Spain (2) · Sweden (2) · Belgium (1) · Czechia (1) · Finland (1) · France (1) · Hungary (1)
Apkar V Apkarian, PhD (2) · Bror Jonzon (2) · Lynn Webster, MD (2) · Andrew Hershey, MD (1) · Bassem Youssef, MD (1) · Bruce Berger, MD (1) · Choonghyeok Choi (1) · Dan A Chiche, MD (1) · David R Boulware, MD, MPH (1) · Deepen Patel, MD (1) · Donald W Lewis, MD (1) · Dr. Sandy Srinivas (1) · Eduardo Vilar-Sanchez, MD (1)
PMID 12783912, PMID 18990046, PMID 19539115, PMID 23628600, PMID 24127200, PMID 24756302, PMID 24756514, PMID 24781936, PMID 25370510, PMID 25370513, PMID 26024112, PMID 26335066, PMID 26554876, PMID 26618282, PMID 26778344, PMID 26934136, PMID 27694262, PMID 28130349, PMID 28492874, PMID 29848361, PMID 30227893, PMID 31356878, PMID 33602696, PMID 39260540, PMID 40676732, PMID 42498485
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