13 completed, 1 active not recruiting, 1 not yet recruiting, 1 withdrawn. 16 Phase 3, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 16 | Completed 13, Active not recruiting 1, Not yet recruiting 1, Withdrawn 1 |
| Phase 2 | 1 | Completed 1 |
Follow Bunion: new trials by email Literature Review of Bunion trials Research Report on Bunion
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 |
|---|---|---|---|---|---|---|
| Phase 3 Bunionectomy Study CPL-01, saline placebo - Postoperative Pain, Bunion | Phase 3 | Not yet recruiting | Cali Pharmaceuticals LLC | 112 | 2027-03-01 | 2026-10-21 |
| A Study of TLC590 for Postsurgical Pain Following Bunionectomy TLC590, Liposomal Bupivacaine, Saline Placebo - Postoperative Pain | Phase 3 | Active not recruiting | TLC Biopharmaceuticals, Inc. | 304 | 2025-11-17 | 2026-07-02 |
| CPL-01 in the Management of Postoperative Pain After Bunionectomy Local anesthetic injection of CPL-01, Naropin, 0.5% Injectable Solution, Placebo - Bunion, Post-operative Pain | Phase 3 | Completed | Cali Pharmaceuticals LLC | 616 | 2023-05-22 | 2026-04-30 |
| A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain Ropivacaine - Bunion | Phase 3 | Completed | PainReform LTD | 428 | 2023-03-13 | 2024-09-19 |
| Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL, EXPAREL Admixed With Bupivacaine HCl vs. Bupivacaine HCl Administered as Combined Sciatic and Saphenous Nerve Blocks for Postsurgical Analgesia in Subjects Undergoing Lower Extremity Surgeries Exparel, Bupivacaine Hydrochloride - Lower Extremity Surgery, Bunion | Phase 3 | Completed | Pacira Pharmaceuticals, Inc | 121 | 2020-10-20 | 2022-07-18 |
| Phase 3, Randomized, Double Blinded, Active Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of EXPAREL Admixed With Bupi vs. Bupi Only Administered as Combined Sciatic and Adductor Canal Nerve Block for Postsurgical Analgesia in Lower Extremity Surgeries EXPAREL 13.3Mg/mL Suspension for Injection, Bupivacaine Hydrochloride - Bunion, Metatarsophalangeal Fusion | Phase 3 | Withdrawn | Pacira Pharmaceuticals, Inc | 2020-06-15 | 2020-08-13 | |
| Bunionectomy Study for Postoperative Analgesia (EPOCH 1) HTX-011, Saline Placebo, Bupivacaine HCl - Postoperative Pain | Phase 3 | Completed | Heron Therapeutics | 412 | 2017-10-24 | 2026-03-02 |
| Evaluation of N1539 Following Bunionectomy Surgery N1539, Intravenous Placebo - Pain, Post-operative | Phase 3 | Completed | Baudax Bio | 201 | 2016-01-01 | 2017-11-17 |
| Safety and Efficacy Study of COV155 for Post-operative Bunionectomy Pain COV155, placebo - Pain, Postoperative, Bunion | Phase 3 | Completed | Mallinckrodt | 406 | 2012-11-01 | 2016-10-19 |
| A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy Tapentadol IR 50 mg, Tapentadol IR 75 mg, Placebo - Hallux Valgus | Phase 3 | Completed | Janssen Research & Development, LLC | 353 | 2012-01-01 | 2014-04-28 |
| Safety and Efficacy of COV795 in Moderate to Severe Post-Operative Bunionectomy Pain With an Open-label Extension COV795, Placebo - Pain, Postoperative, Bunion | Phase 3 | Completed | Mallinckrodt | 329 | 2011-11-01 | 2016-10-21 |
| Study of Postoperative Analgesia in Bunionectomy SKY0402, Placebo - Bunion, Hallux Valgus | Phase 3 | Completed | Pacira Pharmaceuticals, Inc | 193 | 2009-04-01 | 2013-08-05 |
| Efficacy and Safety Study of 4975 to Manage Pain of Bunionectomy 4975, Placebo - Pain | Phase 3 | Completed | Anesiva, Inc. | 300 | 2008-03-01 | 2009-05-04 |
| A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy. Tapentadol (CG5503), oxycodone, placebo - Arthralgia, Bunion | Phase 3 | Completed | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 901 | 2008-02-01 | 2014-05-09 |
| A Safety Study of AQUAVAN® (Fospropofol Disodium) Injection for Sedation During Minor Surgical Procedures. AQUAVAN® (fospropofol disodium) Injection - Procedural Sedation | Phase 2 / Phase 3 | Completed | Eisai Inc. | 123 | 2006-05-01 | 2012-06-20 |
| A Study to Evaluate the Effectiveness and Safety of Tapentadol(CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo Followed by a Voluntary Open Label Extension for Safety. CG5503 IR;tapentadol - Arthralgia, Bunion | Phase 3 | Completed | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | 602 | 2011-06-09 |
Pain, Postoperative (7) · Hallux Valgus (4) · Acute Pain (3) · Pain (3) · Arthralgia (2) · Agnosia (1) · Arteriovenous Fistula (1) · Dilatation, Pathologic (1)
Foot Deformities (16) · Foot Deformities, Acquired (16) · Musculoskeletal Diseases (16) · Pathological Conditions, Signs and Symptoms (12) · Neurologic Manifestations (11) · Signs and Symptoms (11) · Pain (8) · Pathologic Processes (7) · Postoperative Complications (7) · Joint Diseases (2) · Arteriovenous Malformations (1) · Cardiovascular Abnormalities (1) · Cardiovascular Diseases (1) · Congenital Abnormalities (1) · Congenital, Hereditary, and Neonatal Diseases and Abnormalities (1)
Bupivacaine (3) · Injections (2) · Oxycodone (2) · Ropivacaine (2) · 7-propyltheophylline dopamine (1) · Analgesics, Opioid (1) · Morphine (1) · Sodium Chloride (1) · Suspensions (1) · Tapentadol (1) · fospropofol (1) · oxycodone-acetaminophen (1)
Pacira Pharmaceuticals, Inc (3) · Cali Pharmaceuticals LLC (2) · Johnson & Johnson Pharmaceutical Research & Development, L.L.C. (2) · Mallinckrodt (2) · Anesiva, Inc. (1) · Baudax Bio (1) · Eisai Inc. (1) · Heron Therapeutics (1) · Janssen Research & Development, LLC (1) · PainReform LTD (1) · TLC Biopharmaceuticals, Inc. (1)
United States (13) · South Korea (1)
Erol Onel (1) · James B Jones, MD, PharmD (1) · Stephen Daniels, DO (1) · Tien-Tzu Tai, MD (1) · Todd Bertoch, MD (1)
PMID 19203298, PMID 19445652, PMID 21842428, PMID 22900785, PMID 24351079, PMID 25133962, PMID 25157951, PMID 30737315, PMID 31113830, PMID 34284613