A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-18

Study Completion Date

2025-01-31

Brief Summary

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The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a bunionectomy.

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Detailed Description

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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.

Conditions

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Acute Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cebranopadol

once daily for 3 days

Group Type EXPERIMENTAL

Cebranopadol

Intervention Type DRUG

once daily for 3 days

Placebo

Intervention Type DRUG

three times per day for 3 days

Oxycodone IR

four times per day for 3 days

Group Type ACTIVE_COMPARATOR

Oxycodone IR

Intervention Type DRUG

four times per day for 3 days

Placebo

four times per day for 3 days

Group Type PLACEBO_COMPARATOR

Placebo Only

Intervention Type DRUG

four times per day for 3 days

Interventions

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Cebranopadol

once daily for 3 days

Intervention Type DRUG

Oxycodone IR

four times per day for 3 days

Intervention Type DRUG

Placebo Only

four times per day for 3 days

Intervention Type DRUG

Placebo

three times per day for 3 days

Intervention Type DRUG

Other Intervention Names

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TRN-228 oxycodone immediate release

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.

* 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No