21 completed, 2 withdrawn, 1 recruiting, 1 terminated. 7 Phase 1, 7 Phase 3, 6 Phase 2, 6 Phase 4, 2 Not applicable.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 7 | Completed 6, Recruiting 1 |
| Phase 3 | 7 | Completed 6, Withdrawn 1 |
| Phase 2 | 6 | Completed 5, Withdrawn 1 |
| Phase 4 | 6 | Completed 4, Terminated 1, Withdrawn 1 |
| Not applicable | 2 | Completed 2 |
Follow Naproxen Sodium: new trials by email Literature Review of Naproxen Sodium trials Research Report on Naproxen Sodium
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 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 |
| Trial of Naproxen Sodium for the Treatment of OCD in Children With PANDAS Naproxen Sodium, Placebo - PANDAS, Anxiety Disorder | Phase 4 | Terminated | Massachusetts General Hospital | 2 | 2020-10-20 | 2026-05-20 |
| Mechanistic Characterization of Uterine Pain Naproxen Sodium, Placebo - Dysmenorrhea (Disorder), Dysmenorrhea Primary | Phase 4 | Completed | Endeavor Health | 183 | 2019-10-25 | 2026-09-23 |
| 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 |
| 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 |
| Comparison of Different Analgesia Drug Regimens for Pain Control During ESWL for Renal Stones Lidocaine gel,, Naproxen Sodium, Lidocaine gel and Naproxen Sodium - Renal Stone | Not applicable | Completed | Shifa International Hospital | 135 | 2015-07-01 | 2016-06-01 |
| Naproxen for Pain Control With Intrauterine Device Insertion Naproxen sodium, Placebo tablet - Contraception | Not applicable | Completed | Planned Parenthood League of Massachusetts | 119 | 2015-04-01 | 2017-06-22 |
| NSAIDs for Pain After Ankle Fracture Surgery Naproxen, Placebo - Closed Fracture of Ankle | Phase 4 | Withdrawn | Northwell Health | 2014-12-01 | 2015-12-18 | |
| 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 | |
| Effect of Metamizole (Dipyrone) on Renal Function in Salt-depleted Healthy Subjects metamizole, Naproxen - Healthy | Phase 1 | Completed | University Hospital, Basel, Switzerland | 15 | 2014-01-01 | 2015-04-17 |
| 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 |
| Treximet Trademark (TM) in the Prevention and Modification of Disease Progression in Migraine Sumatriptan/Naproxen Sodium, Naproxen Sodium - Migraine | Phase 4 | Completed | Cady, Roger, M.D. | 40 | 2010-12-01 | 2013-05-21 |
| Treximet in the Treatment of Chronic Migraine Sumatriptan/Naproxen Sodium, Naproxen Sodium - Chronic Migraine | Phase 4 | Completed | Cady, Roger, M.D. | 56 | 2010-09-01 | 2013-07-03 |
| Study to Evaluate Efficacy and Safety of IW-6118 in Patients Undergoing Third Molar Extraction IW-6118, Matching Placebo, Naproxen Sodium - Healthy | Phase 2 | Completed | Ironwood Pharmaceuticals, Inc. | 90 | 2010-06-01 | 2022-08-11 |
| Fast & Fed Pharmacokinetic (PK) Study Naproxen sodium - Bioavailability | Phase 1 | Completed | Bayer | 32 | 2008-01-01 | 2013-05-03 |
| Effect of Naproxen, Aspirin, Celecoxib, or Clopidogrel on the Healing of Stomach and Intestinal Ulcers Naproxen, Aspirin, Celecoxib - Gastroduodenal Ulcer | Phase 4 | Completed | Research Associates of New York, LLP | 125 | 2007-10-01 | 2008-10-23 |
| Bunionectomy Study (0000-063) pregabalin, naproxen sodium, Comparator: Placebo - Acute Pain | Phase 1 | Completed | Merck Sharp & Dohme LLC | 100 | 2007-07-01 | 2015-04-10 |
| Bioequivalence Study of Naproxen Sodium 550 mg Tablets Under Fed Conditions Naproxen Sodium - Healthy | Phase 1 | Completed | Dr. Reddy's Laboratories Limited | 26 | 2006-05-01 | 2010-01-20 |
Showing 20 of 25. Sign in to see all of them.
Migraine Disorders (4) · Pain (3) · Dysmenorrhea (2) · Toothache (2) · Acquired Immunodeficiency Syndrome (1) · Acute Pain (1) · Agnosia (1) · Anxiety Disorders (1) · Autoimmune Diseases (1) · Carcinoma, Squamous Cell (1) · Fanconi Anemia (1) · Head and Neck Neoplasms (1) · Immune Reconstitution Inflammatory Syndrome (1) · Leiomyoma (1) · Nephrolithiasis (1)
Cady, Roger, M.D. (2) · Dr. Reddy's Laboratories Limited (2) · POZEN (2) · Antibe Therapeutics Inc. (1) · Bayer (1) · Biogen (1) · Boehringer Ingelheim (1) · Dow University of Health Sciences (1) · Endeavor Health (1) · Ironwood Pharmaceuticals, Inc. (1) · Johnson & Johnson Consumer Inc. (J&JCI) (1) · Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (1) · Massachusetts General Hospital (1) · Merck Sharp & Dohme LLC (1) · Northwell Health (1)
United States (14) · India (2) · Canada (1) · Pakistan (1) · Switzerland (1) · Thailand (1)
David Taylor (2) · Dr. Umesh Dhakate, MBBS (2) · Roger K Cady, MD (2) · Agata Smogorzewska, MD, PhD (1) · Ariel T. Goldman, MD (1) · David R Boulware, MD, MPH (1) · Deepen Patel, MD (1) · Farah Naz, BDS FCPS (1) · James Aisenberg, MD (1) · Kevin M Hellman, PhD (1) · Manuel Haschke, PD (1) · Marsha Tharakan, MD, DDS (1)
PMID 17405970, PMID 21052881, PMID 24020994, PMID 27824753
R01HD098193 (1)