Clinical trials: Bunionectomy
Pain
A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy
The purpose of this study is to evaluate effectiveness of a fixed combination of acetaminophen/naproxen sodium compared with placebo for reduction of pain when administered as multiple doses over a 48-hour period.
- Trial name
- NCT05868122
- Testing
- Acetaminophen/Naproxen Sodium Fixed Combination
- Where
- 4 sites in United States
- Volunteers
- 143 people
- Sponsor
- Johnson & Johnson Consumer Inc. (J&JCI)
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
Post Operative Pain
A Study to Evaluate the Safety, Pharmacokinetics and Preliminary Efficacy of PRF110 in Bunionectomy Surgery
PRF110 is new extended release oily solution formulation of ropivacaine that is intended for local infiltration into surgical wounds.
- Trial name
- NCT02784327
- Testing
- PRF110
- Where
- 2 sites in Israel
- Volunteers
- 15 people
- Sponsor
- PainReform LTD
Acute Pain
Study of PBK_L1704 for the Treatment of Moderate to Severe Acute Pain After Bunionectomy in South Korea
The primary objective is to evaluate the analgesic efficacy of PBK_L1704 compared with placebo in patients with moderate to severe acute pain after bunionectomy.
- Trial name
- NCT05509868
- Testing
- PBK_L1704 0.35mg, PBK_L1704 0.5mg
- Where
- South Korea
- Volunteers
- 182 people
- Sponsor
- Pharmbio Korea Co., Ltd.
Other Acute Postoperative Pain
Study of Indomethacin Capsules to Treat Pain Following Bunionectomy
The purpose of this study is to determine whether Indomethacin [Test] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.
- Trial name
- NCT01543685
- Testing
- Indomethacin, Celecoxib
- Where
- 4 sites in United States
- Volunteers
- 462 people
- Sponsor
- Iroko Pharmaceuticals, LLC
Moderate to Severe Postoperative Pain
Comparison of the Efficacy and Safety of Q8003 Versus Its Individual Components in Bunionectomy Patients
This is a randomized, double-blind, multicenter, fixed dose factorial study of Q8003 12 mg/8 mg versus its individual morphine sulfate and oxycodone hydrochloride components for the management of acute moderate to severe…
- Trial name
- NCT01016808
- Testing
- Q8003, Morphine sulfate, Oxycodone HCl
- Where
- 5 sites in United States
- Volunteers
- 522 people
- Sponsor
- QRxPharma Inc.
Bunionectomy, Hallux Valgus
Phase 3, Sciatic Nerve Block With EXPAREL for Subjects Undergoing Bunionectomy
The study is conducted sequentially in two parts. Part A: The purpose is to obtain information on pharmacokinetic (PK) profile, pharmacodynamics (PD), efficacy, safety, and to assess the performance of 266 mg EXPAREL vs 133 mg…
- Trial name
- NCT05157841
- Testing
- Bupivacaine liposome injectable suspension 266 mg, Bupivacaine HCl, Bupivacaine liposome injectable suspension 133 mg
- Where
- 7 sites in United States
- Volunteers
- 185 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
Post Operative Pain
Bunionectomy Trial With GRT6005
The purpose of the trial is to determine whether the new centrally acting analgesic is effective in comparison to placebo and an active comparator (morphine).
- Trial name
- NCT00872885
- Testing
- GRT6005, Morphine
- Where
- United States
- Volunteers
- 258 people
- Sponsor
- Tris Pharma, Inc.
Post Operative Pain
Maxigesic IV Phase 3 Bunionectomy Study
The purpose of the study is to determine the clinical efficacy and safety of Maxigesic IV, acetaminophen IV, Ibuprofen IV versus placebo IV for the treatment of acute postoperative pain after bunionectomy
- Trial name
- NCT02689063
- Testing
- Maxigesic IV, IV Acetaminophen, IV Ibuprofen
- Where
- 2 sites in United States
- Volunteers
- 276 people
- Sponsor
- AFT Pharmaceuticals, Ltd.
Postoperative Pain, Bunions
Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
A Phase 2, Randomized, Controlled, Multicenter, Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
- Trial name
- NCT02762929
- Testing
- HTX-011A, HTX-011B, HTX-002
- Where
- 5 sites in United States
- Volunteers
- 430 people
- Sponsor
- Heron Therapeutics
Pain, Post-surgical
Analgesic Efficacy Of Valdecoxib In Patients Following Bunion Surgery
To assess the analgesic efficacy and general safety of 2 dosing regimens of valdecoxib compared to placebo on the first post-operative day in patients with moderate or severe pain following bunionectomy surgery.
- Trial name
- NCT00653354
- Testing
- valdecoxib
- Where
- 21 sites in United States
- Volunteers
- 360 people
- Sponsor
- Pfizer
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.
Pain
Hydrocodone/Acetaminophen for Acute Pain Following Bunionectomy
The primary purpose of this study was to evaluate analgesic efficacy and safety of hydrocodone/acetaminophen extended release compared to placebo in moderate to severe pain following primary unilateral first metatarsal…
- Trial name
- NCT01038609
- Testing
- Hydrocodone/Acetaminophen Extended Release, Acetaminophen, Morphine Extended Release
- Where
- 4 sites in United States
- Volunteers
- 250 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Pain, Post-operative
Placebo-Controlled Evaluation of Intranasal Dexmedetomidine for Postoperative Analgesia Following Bunionectomy
The primary objective of this study is to evaluate the analgesic efficacy of two dose levels of DEX-IN compared with placebo, using the summed pain intensity difference over the first 48 hours (SPID48) in subjects with acute…
- Trial name
- NCT02169336
- Testing
- Intranasal Dexmedetomidine
- Where
- 3 sites in United States
- Volunteers
- 95 people
- Sponsor
- Baudax Bio
Postoperative Pain
Bunionectomy Study for Postoperative Analgesia (EPOCH 1)
This is a Phase 3, randomized, double-blind, saline placebo- and active-controlled, multicenter study to evaluate the analgesic efficacy and safety of HTX 011 administered via local administration into the surgical site in…
- Trial name
- NCT03295721
- Testing
- HTX-011, Bupivacaine HCl, Luer-lock applicator
- Where
- 15 sites in United States
- Volunteers
- 412 people
- Sponsor
- Heron Therapeutics
Pain, Postoperative
Phase 3 Efficacy and Safety Study of VVZ-149 Injections for Postoperative Pain Following Bunionectomy
The purpose of this phase 3 study is to evaluate the efficacy and safety of an analgesic drug candidate, VVZ-149 Injections for treating post-operative pain following bunionectomy.
- Trial name
- NCT04430088
- Testing
- VVZ-149 Injections
- Where
- 3 sites in United States
- Volunteers
- 300 people
- Sponsor
- Vivozon, Inc.
Postoperative Pain
A Multicenter Active Comparator Study of HC-ER in Adults Following Bunionectomy Surgery
The purpose of the study is to establish a dose-response relationship among several capsule strengths of Hydrocodone Bitartrate Extended Release (HC-ER) and to compare the efficacy to placebo following bunionectomy surgery
- Trial name
- NCT02197156
- Testing
- 10 mg HC-ER, 20 mg HC-ER, 30 mg HC-ER
- Volunteers
- 241 people
- Sponsor
- Zogenix, Inc.
Acute Pain
XG005 for Pain Control in Subjects Undergoing Bunionectomy
This study will evaluate the safety, efficacy, and PK of low dose (750 mg) and high-dose (1250 mg) XG005 oral tablets compared with placebo in subjects undergoing bunionectomy.
- Trial name
- NCT06017999
- Testing
- XG005 tablet
- Where
- 8 sites in United States
- Volunteers
- 450 people
- Sponsor
- Xgene Pharmaceutical Group
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