Acute Pain
Conditions
Keywords
Bunionectomy
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a bunionectomy.
Detailed description
This study is a Phase 3, multicenter, randomized, double-blind, placebo- and active-controlled parallel-group study to evaluate the efficacy and safety of cebranopadol in the treatment of postoperative pain following primary unilateral bunionectomy with first metatarsal osteotomy. The study will be conducted in 3 phases: Screening, Treatment, and Follow-up.
Interventions
DRUGCebranopadol
once daily for 3 days
DRUGOxycodone IR
four times per day for 3 days
DRUGPlacebo Only
four times per day for 3 days
DRUGPlacebo
three times per day for 3 days
Sponsors
Tris Pharma, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria Before Surgery: * Scheduled to undergo primary unilateral bunionectomy with first metatarsal osteotomy and internal fixation with no collateral procedures, using anesthesiologic and surgical procedures planned. * Must be able to adhere to the visit schedule, complete all study assessments and protocol requirements, including self-reported questionnaires. Key
Exclusion criteria
Before Surgery: * Any clinically significant disease, medical condition, or laboratory finding that in the investigator's opinion may interfere with the study procedures or data integrity, or compromise the safety of the subject. * Secondary (i.e., unrelated to bunion) current painful condition that could confound the interpretation of efficacy, safety, or tolerability data in the study, in the opinion of the investigator. * Subjects who require any analgesic for secondary (i.e., unrelated to bunion) painful condition that might impact the subject's ability to properly assess their postoperative pain, or that may require treatment during the Treatment Phase. * History of allergy or hypersensitivity to any opioid analgesics, anesthetics, ibuprofen, or other NSAIDs. Immediate Postoperative
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain NRS area under the curve: cebranopadol vs. placebo | 2-48 hours |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects who require opioid rescue medication | 1-7 Days |
| Global Assessment of Satisfaction | 1-7 Days |
| Total oxycodone rescue consumption | 1-7 Days |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORTodd M Bertoch, MD
Cenexel JBR
Outcome results
None listed