Clinical trials: Bunionectomy
Acute Post-surgical Pain
Co-crystal E-58425 vs Tramadol and Celecoxib for Moderate to Severe Acute Pain After Bunionectomy. Phase III Clinical Trial.
This is a Phase 3, randomized, double-blind, controlled, parallel-group, multicenter clinical trial with co-crystal E-58425 compared to tramadol, to celecoxib, and to placebo.
- Trial name
- NCT03108482
- Testing
- Co-crystal E-58425 (Tramadol/Celecoxib), Tramadol (Ultram®), Celecoxib (Celebrex®)
- Where
- 5 sites in United States
- Volunteers
- 637 people
- Sponsor
- Esteve Pharmaceuticals, S.A.
Bunion, Hallux Valgus
Study of Postoperative Analgesia in Bunionectomy
After undergoing bunion surgery, patients are given a pain medicine injection that may last for up to several days or a placebo. Their pain and pain medicine use is then monitored.
- Trial name
- NCT00890682
- Testing
- SKY0402
- Where
- United States
- Volunteers
- 193 people
- Sponsor
- Pacira Pharmaceuticals, Inc
Postoperative Pain
A Phase 2 Study to Evaluate Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing Bunionectomy
A Phase 2, Randomized, Double-Blind, Placebo- and Comparator-Controlled Trial to Evaluate the Safety and Efficacy of Combination Pregabalin and Acetaminophen Compared to Acetaminophen and Placebo in Subjects Undergoing…
- Trial name
- NCT04495283
- Testing
- Pregabalin, Acetaminophen
- Where
- 2 sites in United States
- Volunteers
- 87 people, healthy volunteers welcome
- Sponsor
- Nevakar, Inc.
Hallux Valgus
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy Compared With Placebo
The purpose of this study is to evaluate the analgesic efficacy and safety of tapentadol immediate-release (IR [CG5503]) for use in the relief of moderate to severe acute pain, compared with placebo, in adult Taiwanese patients…
- Trial name
- NCT01813890
- Testing
- Tapentadol IR 50 mg, Tapentadol IR 75 mg
- Where
- 3 sites in Taiwan
- Volunteers
- 60 people
- Sponsor
- Janssen-Cilag International NV
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, Pain
A Trial to Evaluate CG5503 Efficacy and Safety in Acute Pain After Bunionectomy
The main objective of this trial is to demonstrate the efficacy and safety of multiple-dose application of oral application of CG5503 IR 75mg compared to placebo and to assess safety and tolerability of CG5503 IR 75mg in subjects…
- Conditions
- Bunionectomy, Pain, Postoperative Pain, Acute Pain
- Trial name
- NCT00609466
- Testing
- CG5503 IR, Morphine
- Where
- 6 sites in United States
- Volunteers
- 291 people
- Sponsor
- Grünenthal GmbH
Acute Pain
Study of Oliceridine (TRV130) for the Treatment of Moderate to Severe Acute Pain After Bunionectomy
The primary objective is to evaluate the analgesic efficacy of intravenous (IV) oliceridine administered as needed (PRN) compared with placebo in patients with moderate to severe acute postoperative pain after bunionectomy.
- Trial name
- APOLLO-1 (NCT02815709)
- Testing
- Oliceridine, Morphine
- Where
- 7 sites in United States
- Volunteers
- 418 people, healthy volunteers welcome
- Sponsor
- Trevena Inc.
Analgesia
HTX-011 for Post-bunionectomy Analgesia
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Two-Part Evaluation of the Efficacy and Safety of Locally Administered HTX-011 for Postoperative Analgesia Following Bunionectomy
- Trial name
- HTX-011 (NCT02471898)
- Testing
- HTX-011
- Where
- United States
- Volunteers
- 71 people
- Sponsor
- Heron Therapeutics
Other Acute Postoperative Pain
Study of Diclofenac Capsules to Treat Pain Following Bunionectomy
The purpose of this study is to determine whether Diclofenac [Test] Capsules are safe and effective for the treatment of bunionectomy pain.
- Trial name
- NCT01462435
- Testing
- Diclofenac Test (lower dose), Diclofenac Test (upper dose), Celecoxib
- Where
- 4 sites in United States
- Volunteers
- 428 people
- Sponsor
- Iroko Pharmaceuticals, LLC
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, Postoperative
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.
- Trial name
- NCT00375934
- Testing
- diclofenac potassium (XP21L)
- Where
- 4 sites in United States
- Volunteers
- 200 people
- Sponsor
- Xanodyne Pharmaceuticals
Arthralgia, Bunion
A Study to Evaluate the Effectiveness and Safety of Tapentadol (CG5503) in the Treatment of Acute Pain From Bunionectomy.
The purpose of this study is to evaluate the effectiveness (level of pain control) and safety of the administration of 2 different dose levels of tapentadol (CG5503) compared with oxycodone and with placebo in subjects who have…
- Conditions
- Arthralgia, Bunion, Hallux Valgus, Pain
- Trial name
- NCT00613938
- Testing
- Tapentadol (CG5503), oxycodone
- Where
- 7 sites in United States
- Volunteers
- 901 people
- Sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Pain, Postoperative
Multicenter Study to Evaluate the Analgesic Efficacy of XP21L in Subjects With Pain Following Bunionectomy Surgery
A multicenter study to evaluate the analgesic efficacy of XP21L in subjects with pain following bunionectomy surgery.
- Trial name
- NCT00366444
- Testing
- diclofenac potassium (XP21L)
- Where
- 6 sites in United States
- Volunteers
- 201 people
- Sponsor
- Xanodyne Pharmaceuticals
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, 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
Pulsed Radiofrequency Energy to Treat Post-Bunionectomy Pain
Multicenter, randomized, controlled, double-blind study to evaluate the use of 3 days of pulsed radiofrequency energy (PRFE) to treat pain after bunionectomy surgery.
- Trial name
- NCT01694199
- Testing
- Pulsed Radiofrequency Energy (PRFE), No Pulsed Radiofrequency Energy (PRFE)
- Where
- 3 sites in United States
- Volunteers
- 139 people
- Sponsor
- Regenesis Biomedical, Inc.
Pain Management
Tramadol Versus Placebo in the Management of Postoperative Pain Following Bunionectomy
The study evaluates the effectiveness and safety of IV tramadol compared to placebo managing postoperative pain following a bunionectomy
- Trial name
- NCT03290378
- Testing
- Tramadol
- Where
- 5 sites in United States
- Volunteers
- 409 people
- Sponsor
- Avenue Therapeutics, Inc.
Pain
Study to Evaluate the Analgesic Efficacy and Safety of Hydrocodone Bitartrate/Acetaminophen Immediate-Release Tablets in Participants With Moderate to Severe Pain Following Bunionectomy
The primary objective of this study is to evaluate the analgesic efficacy of hydrocodone bitartrate/acetaminophen immediate-release tablets at doses of 5.0 milligrams (mg)/325 mg, 7.5 mg/325 mg, and 10 mg/325 mg every 4 to 6…
- Trial name
- NCT02487108
- Testing
- TV-46763
- Where
- 8 sites in United States
- Volunteers
- 569 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Bunion, Pain
Intravenous Tapentadol in Post-Bunionectomy Pain
The purpose of this trial is to established the safety and efficacy of multiple dose treatment with tapentadol IV in an adult population with moderate to severe pain following bunionectomy.
- Trial name
- NCT01435577
- Testing
- Tapentadol
- Where
- United States
- Volunteers
- 177 people
- Sponsor
- Grünenthal GmbH