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RecruitingNCT07845071Updated Sep 30, 2026

An Open-Label, Safety and Efficacy Study of Cebranopadol in Participants With Acute Pain With Surgical or Non-Surgical Origin

A Phase 3 interventional study of Cebranopadol 400 ug in Pain, sponsored by Adneuris Therapeutics, Inc.. Recruiting at 15 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-09-30.

Sponsored by Adneuris Therapeutics, Inc. · Phase 3, Interventional, and Treatment

Updated Sep 30, 2026Site recruiting status changedNewly registeredGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
160
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Pain

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03

In context

Pain

2,219 studies on the registry are indexed under Pain; 915 are open to participants now.

This study's planned enrollment of 160 is above the median of 70 across 1,901 interventional studies indexed under Pain.

Browse Pain studies →

Lead sponsor

This is the only study on the registry with Adneuris Therapeutics, Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
160 participants (estimated)

Study arms

  • Experimental
    Cebranopadol

    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

  • DrugCebranopadol 400 ug

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

06

What researchers measure

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.

    Time frame: From 0 through 48 hours

07

Study locations

8 of 15 sites recruiting
  • 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
08

References and documents

Individual participant data

Plan to share: Yes — Only IPD used in the results publication

No publications or documents are linked to this record.

09

Updates

2 registry updates since Sep 25, 2026
Sites
7 sites changed recruiting status
Sep 30, 2026
Registered
First appeared on the registry
Sep 28, 2026
Show all 2 updates
  1. Sep 30, 2026
    7 sites changed recruiting status
    + 1 other change: date precision
  2. Sep 28, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07845071
Lead sponsor
Adneuris Therapeutics, Inc.
Responsible party
Sponsor
First posted
Sep 28, 2026
Start date
Sep 22, 2026
Primary completion
Jan 2027 (estimated)
Completion
Feb 2027 (estimated)
Last update
Sep 30, 2026

Study contacts

Study Director, Adneuris Therapeutics
Contact
TRN-228-309@trispharma.com
732-940-2800
Emilio Quetglas, MD
Contact
TRN-228-309@trispharma.com
732-940-2800

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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