9 completed, 1 terminated. 6 Phase 1, 3 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 1 | 6 | Completed 6 |
| Phase 3 | 3 | Completed 3 |
| Phase 2 | 1 | Terminated 1 |
Follow naproxen-n-butyl nitrate: new trials by email Literature Review of naproxen-n-butyl nitrate trials Research Report on naproxen-n-butyl nitrate
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 |
|---|---|---|---|---|---|---|
| Pharmacokinetics Study: Determination of Naproxcinod and Its Metabolites After Oral Administration in Male naproxcinod 750 bid, naproxcinod 3000 mg od, naproxen 500 mg bid - Pharmacokinetics | Phase 1 | Completed | NicOx | 24 | 2010-01-01 | 2011-08-11 |
| Effect of Repeated Dosing of Naproxcinod on Renal Hemodynamic and on Sodium Balance in Healthy Volunteers Before and After a Single Dose of Furosemide naproxcinod, Naproxen, placebo - Renal Hemodynamics | Phase 1 | Completed | NicOx | 31 | 2009-01-01 | 2011-06-17 |
| A Pharmacokinetics and Safety Study of Naproxcinod in Subjects With Impaired Renal Function naproxcinod - Renal Failure | Phase 1 | Completed | NicOx | 32 | 2008-05-01 | 2009-01-28 |
| A Study to Assess the Effects of Naproxcinod and Naproxen on Blood Pressure Measurements in Osteoarthritis Patients With Controlled High Blood Pressure naproxcinod 375 mg -750 mg -1125 mg bid, naproxen 250 mg - 500mg -750 mg bid - Osteoarthritis, Hypertension | Phase 1 | Completed | NicOx | 120 | 2008-03-01 | 2011-06-17 |
| To Assess the Effect of Naproxcinod Versus Naproxen and Ibuprofen on Arterial Blood Pressure in Osteoarthritis Patients With Controlled Essential Hypertension naproxcinod 375 mg bid, naproxcinod 750 mg bid, naproxen 250 mg bid - Osteoarthritis, Hypertension | Phase 1 | Completed | NicOx | 300 | 2008-03-01 | 2011-06-17 |
| A Phase 1 Study to Compare the PK and Safety of Naproxcinod in Hepatic Impaired Patients and Matching Healthy Subjects naproxcinod - Liver Disease | Phase 1 | Completed | NicOx | 24 | 2008-01-01 | 2011-06-17 |
| Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Hip Naproxcinod, Naproxen, Placebo - Osteoarthritis, Osteoarthritis, Hip | Phase 3 | Completed | NicOx | 800 | 2007-06-01 | 2009-02-20 |
| Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee Naproxcinod 375 mg bid, Naproxcinod 750 mg bid, Naproxen 500 mg bid - Osteoarthritis | Phase 3 | Completed | NicOx | 1020 | 2007-04-01 | 2011-06-17 |
| Analgesic Efficacy and Safety Study of Naproxcinod in Subjects With Osteoarthritis of the Knee Placebo, Naproxcinod 375 mg, Naproxen - Osteoarthritis | Phase 3 | Completed | NicOx | 918 | 2005-12-01 | 2011-06-17 |
| A Phase II Trial of Calcitriol and Naproxen in Patients With Recurrent Prostate Cancer Calcitriol, Naproxen-n-butyl nitrate - Prostatic Neoplasms, Prostate Cancer | Phase 2 | Terminated | Stanford University | 20 | 2005-03-01 | 2013-01-28 |
Osteoarthritis (5) · Hypertension (2) · Arthritis (1) · Liver Diseases (1) · Osteoarthritis, Hip (1) · Prostatic Neoplasms (1) · Renal Insufficiency (1)
NicOx (9) · Stanford University (1)
United States (7) · Canada (1)
Antonio Rusca, MD FMH (1) · Dr. Sandy Srinivas (1)