NCT07845071

Brief Summary

The purpose of this study is to evaluate the safety and effectiveness of cebranopadol in treating acute pain.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P25-P50 for phase_3 pain

Timeline
4mo left

Started Sep 2026

Shorter than P25 for phase_3 pain

Geographic Reach
1 country

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Sep 2026Feb 2027

First Submitted

Initial submission to the registry

September 22, 2026

Completed
Same day until next milestone

Study Start

First participant enrolled

September 22, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 28, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

September 30, 2026

Status Verified

September 1, 2026

Enrollment Period

3 months

First QC Date

September 22, 2026

Last Update Submit

September 28, 2026

Conditions

Pain

Outcome Measures

Primary Outcomes (1)

  • Sum of pain intensity differences through 48 hours (SPID48)

    Sum of pain intensity differences through 48 hours (SPID48), calculated from NPRS assessments collected following the first administration of cebranopadol.

    From 0 through 48 hours

Study Arms (1)

Cebranopadol

EXPERIMENTAL

Participants receive Cebranopadol 400 µg Starting dose 400 mcg once per day for 14 days or until pain resolves, whichever occurs first.

Drug: Cebranopadol 400 ug

Interventions

Cebranopadol 400 ugDRUG

Participants receive Cebranopadol 400 mcg once per day for 14 days or until pain resolves, whichever occurs first.

Cebranopadol

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults 18 to 75 years of age.
  • Able to provide informed consent.
  • Experiencing moderate to severe acute pain related to: 1) An ambulatory surgical procedure expected to cause pain lasting at least 72 hours, or 2) A traumatic or non-traumatic musculoskeletal condition.
  • Have a pain score of at least 4 on a 0 to 10 pain rating scale before starting study treatment.
  • Willing and able to comply with study requirements

You may not qualify if:

  • Chronic pain condition that requires ongoing pain medication.
  • Significant medical or psychiatric condition that could affect participation or study results.
  • History of substance use disorder or misuse of alcohol or drugs.
  • Current use of medications that may interfere with the study drug or pain assessments.
  • Known allergy or intolerance to cebranopadol or permitted rescue pain medications.
  • Pregnant or breastfeeding.
  • Participation in another clinical trial or receipt of an investigational drug within the protocol-defined period before study entry.
  • Any condition that, in the investigator's opinion, would make participation unsafe or interfere with study assessments.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Adneuris Site 001115

Phoenix, Arizona, 85053, United States

RECRUITING

Adneuris Site 001118

Riverside, California, 92504, United States

RECRUITING

Adneuris Site 001119

Longmont, Colorado, 80501, United States

RECRUITING

Adneuris Site 001122

Savannah, Georgia, 31406, United States

NOT YET RECRUITING

Adneuris Site 001123

O'Fallon, Illinois, 62269, United States

NOT YET RECRUITING

Adneuris Site 001125

Annapolis, Maryland, 21401, United States

RECRUITING

Adneuris Site 001120

Oradell, New Jersey, 07649, United States

RECRUITING

Adneuris Site 001124

Tulsa, Oklahoma, 74137, United States

RECRUITING

Adneuris Site 001110

Bellaire, Texas, 77401, United States

NOT YET RECRUITING

Adneuris Site 001117

Forney, Texas, 75126, United States

RECRUITING

Adneuris Site 001104

McAllen, Texas, 78501, United States

RECRUITING

Adneuris Site 001116

Plano, Texas, 75093, United States

NOT YET RECRUITING

Adneuris Site 001111

San Antonio, Texas, 78240, United States

NOT YET RECRUITING

Adneuris Site 001121

San Antonio, Texas, 78240, United States

NOT YET RECRUITING

Adneuris Site 001101

Salt Lake City, Utah, 84107, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Pain

Interventions

6'-fluoro-4',9'-dihydro-N,N-dimethyl-4-phenylspiro(cyclohexane-1,1'(3'H)-pyrano(3,4-b)indol)-4-amine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Director, Adneuris Therapeutics

CONTACT

732-940-2800TRN-228-309@trispharma.com

Emilio Quetglas, MD

CONTACT

732-940-2800TRN-228-309@trispharma.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 28, 2026

Study Start

September 22, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

September 30, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will share

Only IPD used in the results publication

Locations

US(15)