PainPhase 3NCT07845071
An Open-Label, Safety and Efficacy Study of Cebranopadol in Participants With Acute Pain With Surgical or Non-Surgical Origin
A Phase 3 study testing Cebranopadol 400 ug in people with Pain, run by Adneuris Therapeutics, Inc. at 15 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety and effectiveness of cebranopadol in treating acute pain. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Pain
- What is being tested?
- Cebranopadol 400 ug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 15 sitesUnited States
- Study dates
- 22 Sep 2026to Feb 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country. Contact the study team or a site near you to ask about taking part.
15 sites in 1 country
United States15 sites, 15 recruiting
- Recruiting
Adneuris Site 001125
Annapolis, Maryland, 21401
- Recruiting
Adneuris Site 001110
Bellaire, Texas, 77401
- Recruiting
Adneuris Site 001117
Forney, Texas, 75126
- Recruiting
Adneuris Site 001119
Longmont, Colorado, 80501
- Recruiting
Adneuris Site 001104
McAllen, Texas, 78501
- Recruiting
Adneuris Site 001123
O'Fallon, Illinois, 62269
- Recruiting
Adneuris Site 001120
Oradell, New Jersey, 07649
- Recruiting
Adneuris Site 001115
Phoenix, Arizona, 85053
- Recruiting
Adneuris Site 001116
Plano, Texas, 75093
- Recruiting
Adneuris Site 001118
Riverside, California, 92504
- Recruiting
Adneuris Site 001101
Salt Lake City, Utah, 84107
- Recruiting
Adneuris Site 001111
San Antonio, Texas, 78240
- Recruiting
Adneuris Site 001121
San Antonio, Texas, 78240
- Recruiting
Adneuris Site 001122
Savannah, Georgia, 31406
- Recruiting
Adneuris Site 001124
Tulsa, Oklahoma, 74137
About this study
Official title: An Open-Label, Single-Arm, Multiple-Dose, Phase 3 Safety and Efficacy Study of Cebranopadol in Participants With Moderate to Severe Acute Pain With Surgical or Non-Surgical Origin
The purpose of this study is to evaluate the safety and effectiveness of cebranopadol in treating acute pain.
- Conditions
- Pain
- Being tested
- Cebranopadol 400 ug
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cebranopadol 400 ugDrug
Participants receive Cebranopadol 400 mcg once per day for 14 days or until pain resolves, whichever occurs first.
| Study group | Role | What they receive |
|---|---|---|
| Cebranopadol | Experimental | Participants receive Cebranopadol 400 µg Starting dose 400 mcg once per day for 14 days or until pain resolves, whichever occurs first. Receives: Drug: Cebranopadol 400 ug |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From 0 through 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start22 Sep 2026
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Adneuris Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845071
- Sponsor's protocol ID
- TRN-228-309
- Status last verified
- Oct 2026
- First submitted
- 22 Sep 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only IPD used in the results publication
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Multiple-Dose, Phase 3 Safety and Efficacy Study of Cebranopadol in Participants With Moderate to Severe Acute Pain With Surgical or Non-Surgical Origin
- ClinicalTrials.gov ID
- NCT07845071
- Acronym / sponsor ID
- TRN-228-309
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Adneuris Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 22 Sep 2026 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 28 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and effectiveness of cebranopadol in treating acute pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cebranopadol | Experimental | Drug: Cebranopadol 400 ugParticipants receive Cebranopadol 400 µg Starting dose 400 mcg once per day for 14 days or until pain resolves, whichever occurs first. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cebranopadol 400 ugParticipants receive Cebranopadol 400 mcg once per day for 14 days or until pain resolves, whichever occurs first. | Drug | Cebranopadol |
Primary outcome
Sum of pain intensity differences through 48 hours (SPID48)
Time frame: From 0 through 48 hours
Sum of pain intensity differences through 48 hours (SPID48), calculated from NPRS assessments collected following the first administration of cebranopadol.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: Yes. Only IPD used in the results publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Cebranopadol 400 ug in people with Pain, run by Adneuris Therapeutics, Inc. at 15 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director, Adneuris Therapeutics (732-940-2800, clinicaltrials@trispharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sum of pain intensity differences through 48 hours (SPID48) (time frame: From 0 through 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.