Clinical trial NCT06423703: A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy
Official title: A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain After Primary Unilateral Bunionectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Acute Pain
Keywords: Bunionectomy
Lead sponsor: Tris Pharma, Inc.
Sponsor class: INDUSTRY
First posted: 2024-05-21
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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 Exclusion Criteria:

* Surgical, postsurgical, or anesthetic complication that could confound the interpretation of efficacy, safety, or tolerability data in the study.
* Deviation from the surgical, postsurgical, or anesthetic protocol that could confound the interpretation of efficacy, safety, or tolerability data in the study.
* Evidence of hemodynamic instability or respiratory insufficiency.

Primary outcomes:
measure: Pain NRS area under the curve: cebranopadol vs. placebo
timeFrame: 2-48 hours
Secondary outcomes:
measure: Proportion of subjects who require opioid rescue medication
timeFrame: 1-7 Days
measure: Global Assessment of Satisfaction
timeFrame: 1-7 Days
measure: Total oxycodone rescue consumption
timeFrame: 1-7 Days
Other outcomes:
measure: Incidence of Respiratory Safety Events
timeFrame: 1-7 Days
Locations:
city: Sheffield
country: United States
facility: ALLEVIATE 2 Site 001108
state: Alabama
city: Little Rock
country: United States
facility: ALLEVIATE 2 Site 001106
state: Arkansas
city: Tampa
country: United States
facility: ALLEVIATE 2 Site 001103
state: Florida
city: Atlanta
country: United States
facility: ALLEVIATE 2 Site 001102
state: Georgia
city: Overland Park
country: United States
facility: ALLEVIATE 2 Site 001107
state: Kansas
city: Pasadena
country: United States
facility: ALLEVIATE 2 Site 001105
state: Maryland
city: Houston
country: United States
facility: Alleviate 2 001113
state: Texas
city: McAllen
country: United States
facility: ALLEVIATE 2 Site 001104
state: Texas
city: San Antonio
country: United States
facility: ALLEVIATE 2 Site 001111
state: Texas
city: Salt Lake City
country: United States
facility: ALLEVIATE 2 Site 001101
state: Utah
Study officials:
affiliation: CenExel JBR
name: Todd M Bertoch, MD
role: PRINCIPAL_INVESTIGATOR
References: