15 completed, 2 terminated, 1 recruiting. 12 Phase 2, 5 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 12 | Completed 10, Terminated 2 |
| Phase 3 | 5 | Completed 4, Recruiting 1 |
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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 |
|---|---|---|---|---|---|---|
| Study to Evaluate the Safety and Efficacy of Larsucosterol in Participants With Alcohol-associated Hepatitis (AH) Larsucosterol, Placebo - Hepatitis | Phase 3 | Recruiting | Bausch Health Americas, Inc. | 350 | 2026-01-29 | 2026-10-15 |
| A Phase 2b Study in Subjects With Alcoholic Hepatitis to Evaluate Safety and Efficacy of DUR-928 Treatment DUR-928 30 mg, DUR-928 90 mg, Placebo+ Standard of Care (SOC) - Alcoholic Hepatitis | Phase 2 | Completed | Durect | 307 | 2021-01-22 | 2024-09-05 |
| DUR-928 in Subjects With SARS-CoV-2 With Acute Lung, Liver or Kidney Injury DUR-928, Placebo - SARS-CoV-2 | Phase 2 | Terminated | Durect | 2 | 2020-09-21 | 2022-08-05 |
| Safety and Efficacy Study of DUR-928 Topical Solution in Subjects With Plaque Psoriasis DUR-928 Topical Solution, Vehicle Topical Solution - Plaque Psoriasis | Phase 2 | Completed | Durect | 25 | 2019-02-21 | 2022-09-02 |
| A Research Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DUR-928 in Patients With Alcoholic Hepatitis DUR-928 30 mg, DUR-928 90 mg, DUR-928 150 mg - Alcoholic Hepatitis | Phase 2 | Completed | Durect | 19 | 2018-04-18 | 2024-09-24 |
| A Research Study to Evaluate Safety and Efficacy of DUR-928 in Subjects With Primary Sclerosing Cholangitis (PSC) DUR-928 - Primary Sclerosing Cholangitis | Phase 2 | Terminated | Durect | 5 | 2018-01-22 | 2022-10-17 |
| Evaluate Long-term Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD ORADUR®-Methylphenidate - Attention Deficit Hyperactivity Disorder | Phase 3 | Completed | Orient Pharma Co., Ltd. | 64 | 2016-01-01 | 2021-12-15 |
| Trial of Extended Release Bupivacaine for Pain Relief After Surgery SABER-Bupivacaine (Part 1), SABER-Bupivacaine (Part 2), Saline Placebo - Post Operative Pain | Phase 3 | Completed | Durect | 399 | 2015-11-01 | 2021-07-13 |
| Evaluate Safety and Efficacy of ORADUR®-Methylphenidate in Children and Adolescents With ADHD Placebo First, then ORADUR®, ORADUR® First, then Placebo - Attention Deficit Hyperactivity Disorder | Phase 3 | Completed | Orient Pharma Co., Ltd. | 114 | 2015-06-01 | 2021-12-06 |
| An Extension Trial to Evaluate Long-term Safety of SABER™-Bupivacaine for Pain Following Shoulder Surgery Pain | Completed | Durect | 47 | 2010-06-01 | 2022-06-15 | |
| Study of the Efficacy and Safety of Bupivacaine TTS Patch in Patients With Chronic Low Back Pain Bupivacaine TTS (Bupivacaine Patch), Placebo patch - Chronic Low Back Pain | Phase 2 | Completed | Durect | 263 | 2010-03-01 | 2022-06-15 |
| Bupivacaine Effectiveness and Safety in SABER® Trial SABER-Bupivacaine, Bupivacaine HCl, SABER-Placebo - Postoperative Pain, Abdominal Surgery | Phase 3 | Completed | Durect | 331 | 2009-12-01 | 2021-06-01 |
| An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Undergoing Hysterectomy SABER-Bupivacaine Treatment 1a, Placebo SABER-Bupivacaine Treatment 1b, Bupivacaine HCl Treatment 1c - Postoperative Pain | Phase 2 | Completed | Durect | 115 | 2009-05-01 | 2021-06-01 |
| An International Trial to Evaluate the Efficacy and Safety of SABER®-Bupivacaine for Postoperative Pain Control in Patients Following Arthroscopic Shoulder Surgery SABER-Bupivacaine Treatment 1a, Placebo SABER-Bupivacaine Treatment 1b, Bupivacaine HCl Treatment 1c - Postoperative Pain | Phase 2 | Completed | Durect | 107 | 2009-04-01 | 2021-06-09 |
| A Safety and Effectiveness Study of SABER®-Bupivacaine for Pain Following Shoulder Surgery SABER-Bupivacaine, SABER-Placebo - Postoperative Pain | Phase 2 | Completed | Durect | 60 | 2008-12-01 | 2021-06-01 |
| Open Label, Safety Study of EN3270 in Patients With Moderate to Severe Non-malignant, Chronic Pain EN3270 - Chronic, Non Malignant Pain | Phase 2 | Completed | Durect | 77 | 2007-06-01 | 2012-02-23 |
| A Safety and Efficacy Study of SABER®-Bupivacaine for Pain Following Hernia Repair SABER-Bupivacaine, SABER-Placebo - Postoperative Pain, Hernia | Phase 2 | Completed | Durect | 124 | 2007-01-01 | 2021-05-27 |
| Study of a Bupivacaine Patch (Eladur™) to Treat Post- Herpetic Neuralgia Transdermal/Patch (Bupivacaine TTS [Eladur™]) - Postherpetic Neuralgia, Pain | Phase 2 | Completed | Durect | 60 | 2006-09-01 | 2009-09-11 |
Pain, Postoperative (6) · Hepatitis, Alcoholic (3) · Attention Deficit Disorder with Hyperactivity (2) · Pain (2) · Bronchiolitis Obliterans Syndrome (1) · Cholangitis, Sclerosing (1) · Hepatitis (1) · Hernia (1) · Herpes Zoster (1) · Neuralgia (1) · Neuralgia, Postherpetic (1)
Bupivacaine (2) · Administration, Cutaneous (1) · Transdermal Patch (1)
United States (11) · Australia (5) · New Zealand (4) · Austria (2) · France (2) · Germany (2) · Latvia (2) · Sweden (2) · Taiwan (2) · United Kingdom (2) · Belgium (1) · Hungary (1) · Poland (1)
Dmitri Lissin, MD (4) · Robert Gordon, MD (2) · Alastair Smith, MD (1) · Chi-Tai Chang, PhD (1) · Dave Ellis, MD (1) · Paul Meisner, PharmD (1) · Robert Gordon, MD, FACS (1) · Shirley Lin (1) · Tony Andrasfay (1) · Varsha Bhatt, PhD (1)
PMID 22510183, PMID 33395356, PMID 36251766, PMID 37011138, PMID 39873544, PMID 40304564