Clinical trials: Bunion
Postoperative Pain, Bunion
Phase 3 Bunionectomy Study
Patients with a bunion will have that repaired and then pain and rescue medicine use will be evaluated.
- Trial name
- NCT07490496
- Testing
- CPL-01
- Where
- United States
- Volunteers
- 112 people
- Sponsor
- Cali Pharmaceuticals LLC
Postoperative Pain
Phase 2 Bunionectomy HTX-011 Administration Study
This is a Phase 2, open-label, multi-cohort study to evaluate the analgesic efficacy, safety, and pharmacokinetics (PK) of a single, individualized dose of HTX-011 administered into the surgical site as a monotherapy or with…
- Trial name
- NCT03718039
- Testing
- HTX-011, Luer Lock applicator, Vial access device
- Where
- United States
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Heron Therapeutics
Pain Management
A Clinical Trial of MK-6916 in Participants With Pain After Bunion Removal Surgery (MK-6916-007)
Researchers are looking for new treatments for pain. While there are many approved treatments for pain, the treatments do not work well for everyone. People can also become addicted to certain pain medicines.
- Trial name
- NCT07862595
- Testing
- MK-6916, Hydrocodone/acetaminophen (HB/APAP), Rescue Medication
- Volunteers
- 380 people
- Sponsor
- Merck Sharp & Dohme LLC
Hallux Limitus of Left Great Toe, Rheumatoid Arthritis
Mid-term Outcomes of First MTP Arthroplasty With Primus™ FGT Implant.
Foot silicone implants suffer from bad reputation on the market, due to poor results obtained with the first generations of implants.
- Conditions
- Hallux Limitus of Left Great Toe, Rheumatoid Arthritis, Arthritis of 1st Metatarsophalangeal Joint, Osteoarthritis
- Trial name
- NCT02350881
- Testing
- Primus FGTI (Flexible Great toe Implant)
- Where
- Italy
- Volunteers
- 70 people
- Sponsor
- Stryker Trauma and Extremities
Bunion
A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain
PRF-110 is a viscous, yellowish clear oily solution of ropivacaine intended for administration into surgical sites to provide post-operative analgesia.
- Trial name
- NCT05773846
- Testing
- Ropivacaine
- Where
- 7 sites in United States
- Volunteers
- 428 people
- Sponsor
- PainReform LTD
Bunions, Postoperative Pain
Dose-Escalation Study of HTX-034 Following Bunionectomy
This was a Phase 1b/2, randomized, blinded, active-controlled study. Phase 1b evaluated escalating doses of HTX-034 compared with bupivacaine HCl.
- Trial name
- NCT04398329
- Testing
- HTX-034 low dose, HTX-034 high dose, Luer lock applicator
- Where
- 4 sites in United States
- Volunteers
- 78 people
- Sponsor
- Heron Therapeutics
Pain
Efficacy and Safety Study of 4975 to Manage Pain of Bunionectomy
The primary purpose of this study is to compare the analgesic efficacy of a single intraoperative administration of 4975 vs. Placebo in the management of acute postoperative pain in patients undergoing bunionectomy.
- Trial name
- NCT00656578
- Testing
- 4975
- Where
- 6 sites in United States
- Volunteers
- 300 people
- Sponsor
- Anesiva, Inc.
Pain, Postoperative, Bunion
Safety and Efficacy Study of COV155 for Post-operative Bunionectomy Pain
The purpose of this study is to show the effectiveness of COV155 compared to placebo in subjects with acute moderate to severe pain following bunionectomy surgery.
- Trial name
- NCT01743625
- Testing
- COV155
- Where
- 5 sites in United States
- Volunteers
- 406 people
- Sponsor
- Mallinckrodt
Bunion
Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety, of EXPAREL Administered as Sciatic Nerve Block (In Popliteal Fossa), for Postsurgical Analgesia in Subjects Undergoing Bunionectomy
This is a pilot, open label, single center study in 40 subjects undergoing bunionectomy. The study will assess and collect information on pharmacokinetics, pharmacodynamics, safety and efficacy of EXPAREL administered as a…
- Trial name
- NCT04002089
- Testing
- Exparel Injectable Product, Bupivacaine
- Where
- United States
- Volunteers
- 45 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Pain, Post-operative
Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy Surgery
The primary objective of this study is to evaluate the analgesic efficacy, on Post-Operative Day (POD) 1, of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects…
- Trial name
- NCT02284243
- Testing
- Intranasal Dexmedetomidine
- Where
- 3 sites in United States
- Volunteers
- 168 people
- Sponsor
- Baudax Bio
Hallux Valgus and Bunion
Post-Operative Pain and Opioid Reduction Trial After Bunionectomy
This is a Phase 2b, randomized, double blind, placebo and active controlled study with an Ascending Dose Stage and an optional Dose Expansion Stage in subjects undergoing bunionectomy.
- Trial name
- MERIT-2 (NCT05411861)
- Testing
- Analgesic Non Narcotic
- Where
- 3 sites in United States
- Volunteers
- 73 people
- Sponsor
- Cali Pharmaceuticals LLC
Hallux Valgus
Efficacy and Safety of Intranasal Morphine for Pain After Bunion Surgery
Study designed to evaluate the efficacy and safety of Intranasal (IN) Morphine Nasal Spray (MNS075) 3.75 mg, 7.5 mg, 15 mg, and 30 mg, intravenous (IV) morphine 7.5 mg, or IN placebo in patients with moderate to severe…
- Trial name
- NCT00388011
- Testing
- Intranasal Morphine (MNS075) 3.75 mg, Intravenous Morphine 7.5 mg, Intranasal morphine (MNS075) 7.5 mg
- Volunteers
- 187 people
- Sponsor
- Javelin Pharmaceuticals
Pain, Post-operative
Placebo-Controlled Evaluation of N1539 Following Bunionectomy Surgery
The primary objective of this study is to evaluate the safety of N1539 in subjects with acute moderate to severe pain following unilateral bunionectomy.
- Trial name
- NCT02540265
- Testing
- N1539
- Where
- United States
- Volunteers
- 59 people
- Sponsor
- Baudax Bio
Arthrodesis, Bunion
Early Weight-Bearing After Lapidus Arthrodesis
The goal of this research study is to determine if union rates are affected by early weight-bearing after Lapidus Arthrodesis using the Phantom™ Intramedullary Nail.
- Conditions
- Arthrodesis, Bunion, Hallux Valgus
- Trial name
- NCT03257540
- Testing
- Small Bone Intramedullary Nail
- Where
- 3 sites in United States
- Volunteers
- 8 people
- Sponsor
- Paragon 28
Hallux Valgus, Bunion
Early Weight-Bearing After the Lapiplasty Mini-Incision Procedure (Mini3D)
Prospective, multicenter, unblinded study to evaluate outcomes of the Lapiplasty® Procedure using the Lapiplasty® Mini-Incision™ System for patients in need of hallux valgus surgery.
- Trial name
- Mini3D (NCT05082012)
- Testing
- Treatment of Hallux Valgus
- Where
- 10 sites in United States
- Volunteers
- 123 people, healthy volunteers welcome
- Sponsor
- Treace Medical Concepts, Inc.
Hallux Valgus
A Study of Tapentadol Immediate-Release in the Treatment of Patients With Acute Pain From Bunionectomy
The purpose of this study is to demonstrate the efficacy of at least 1 dose of tapentadol IR 50 mg and/or 75 mg versus placebo using the sum of pain intensity difference at 48 hours (SPID48) to measure analgesic effect in Korean…
- Trial name
- NCT01516008
- Testing
- Tapentadol IR 50 mg, Tapentadol IR 75 mg
- Where
- 7 sites in South Korea
- Volunteers
- 353 people
- Sponsor
- Janssen Research & Development, LLC
Bunionectomy, Bunion
Postsurgical Analgesia After Unilateral Bunionectomy
The study is designed to evaluate the safety, efficacy, and pharmacokinetics (PK) of two doses of AMT-143 in participants after unilateral bunionectomy.
- Trial name
- NCT07858734
- Testing
- AMT-143
- Volunteers
- 60 people
- Sponsor
- AmacaThera Inc.
Lower Extremity Surgery, Bunion
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
This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.
- Conditions
- Lower Extremity Surgery, Bunion, Metatarsophalangeal Fushion, Midfoot Fusion
- Trial name
- STRIDE (NCT04518462)
- Testing
- Exparel, Bupivacaine Hydrochloride
- Where
- 5 sites in United States
- Volunteers
- 121 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Bunion, Post-operative Pain
CPL-01 in the Management of Postoperative Pain After Bunionectomy
Subjects receive study drug during bunionectomy and are followed for pain and opioid use, with the hypothesis that those who receive CPL-01 will have less pain and less opioid use than either control arm.
- Trial name
- NCT05831449
- Testing
- Local anesthetic injection of CPL-01, Naropin, 0.5% Injectable Solution, Morphine rescue medication
- Where
- United States
- Volunteers
- 616 people
- Sponsor
- Cali Pharmaceuticals LLC
Postoperative Pain
A Study of TLC590 for Postsurgical Pain Following Bunionectomy
This is a Phase 3, randomized, double-blind, comparator- and placebo-controlled study to evaluate analgesic efficacy and safety of TLC590 via local infiltration in adult subjects following bunionectomy.
- Trial name
- NCT07222748
- Testing
- TLC590, Liposomal Bupivacaine
- Where
- 4 sites in United States
- Volunteers
- 304 people
- Sponsor
- TLC Biopharmaceuticals, Inc.