## Protocol Section
### Identification Module
**NCT ID:** NCT06423703

**Acronym:** ALLEVIATE2

**Brief Title:** 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

#### Organization Study ID Info
**ID:** TRN-228-302
#### Organization
**Class:** INDUSTRY
**Full Name:** Tris Pharma, Inc.
### Status Module
#### Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-21

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-11

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Tris Pharma, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** True

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Acute Pain

**Keywords:**

- Bunionectomy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 240

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** once daily for 3 days

**Intervention Names:**

- Drug: Cebranopadol

- Drug: Placebo

**Label:** Cebranopadol

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** four times per day for 3 days

**Intervention Names:**

- Drug: Oxycodone IR

**Label:** Oxycodone IR

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Description:** three times per day 3 days (with cebranopadol); four times per day for 3 days (placebo arm)

**Intervention Names:**

- Drug: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Cebranopadol

**Description:** once daily for 3 days

**Name:** Cebranopadol

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Oxycodone IR

**Description:** four times per day for 3 days

**Name:** Oxycodone IR

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Cebranopadol

- Placebo

**Description:** three times per day 3 days (with cebranopadol), four times per day for 3 days (placebo arm)

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Other Outcomes

**Measure:** Incidence of Respiratory Safety Events

**Time Frame:** 0-72 hours

#### Primary Outcomes

**Measure:** Pain NRS area under the curve: cebranopadol vs. placebo

**Time Frame:** 2-48 hours

#### Secondary Outcomes

**Measure:** Proportion of subjects who require opioid rescue medication

**Time Frame:** 0-72 hours

**Measure:** Global Assessment of Satisfaction

**Time Frame:** 0-72 hours

**Measure:** Total oxycodone rescue consumption

**Time Frame:** 0-72 hours

### Eligibility Module

**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.

**Maximum Age:** 75 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clinicalaffairs@trispharma.com

**Name:** Antonio Pardo, MD

**Phone:** 732-823-4755

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Sheffield

**Country:** United States

**Facility:** ALLEVIATE 2 Site 001108

**State:** Alabama

**Zip:** 35660

**Location 2:**

**City:** Little Rock

**Country:** United States

**Facility:** ALLEVIATE 2 Site 001106

**State:** Arkansas

**Zip:** 72211

**Location 3:**

**City:** Tampa

**Country:** United States

**Facility:** ALLEVIATE 2 Site 001103

**State:** Florida

**Zip:** 33613

**Location 4:**

**City:** Atlanta

**Country:** United States

**Facility:** ALLEVIATE 2 Site 001102

**State:** Georgia

**Zip:** 30331

**Location 5:**

**City:** Overland Park

**Country:** United States

**Facility:** ALLEVIATE 2 Site 001107

**State:** Kansas

**Zip:** 66212

**Location 6:**

**City:** Pasadena

**Country:** United States

**Facility:** ALLEVIATE 2 Site 001105

**State:** Maryland

**Zip:** 21122

**Location 7:**

**City:** McAllen

**Country:** United States

**Facility:** ALLEVIATE 2 Site 001104

**State:** Texas

**Zip:** 78501

**Location 8:**

**City:** Salt Lake City

**Country:** United States

**Facility:** ALLEVIATE 2 Site 001101

**State:** Utah

**Zip:** 84107

#### Overall Officials

**Official 1:**

**Affiliation:** CenExel JBR

**Name:** Todd M Bertoch, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC10

- Name: Nervous System Diseases

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M29525

- Name: Acute Pain

- Relevance: HIGH

- As Found: Acute Pain

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: T170

- Name: Acute Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000059787

- Term: Acute Pain

### Intervention Browse Module - Ancestors

- ID: D000000701

- Term: Analgesics, Opioid

- ID: D000009294

- Term: Narcotics

- ID: D000002492

- Term: Central Nervous System Depressants

- ID: D000045505

- Term: Physiological Effects of Drugs

- ID: D000000700

- Term: Analgesics

- ID: D000018689

- Term: Sensory System Agents

- ID: D000018373

- Term: Peripheral Nervous System Agents

### Intervention Browse Module - Browse Branches

- Abbrev: Analg

- Name: Analgesics

- Abbrev: CNSDep

- Name: Central Nervous System Depressants

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M13020

- Name: Oxycodone

- Relevance: HIGH

- As Found: Valve

- ID: M4032

- Name: Analgesics

- Relevance: LOW

- As Found: Unknown

- ID: M4033

- Name: Analgesics, Opioid

- Relevance: LOW

- As Found: Unknown

- ID: M12245

- Name: Narcotics

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000010098

- Term: Oxycodone

### Misc Info Module

- Version Holder: 2024-05-31
