Acute PainPhase 3ALLEVIATE1NCT06545097
A Study of Cebranopadol for the Treatment of Acute Pain After Abdominoplasty
A Phase 3 study testing Cebranopadol 400 ug and Cebranopadol 200 ug in people with Acute Pain, run by Tris Pharma, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a Abdominoplasty. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Pain
- What is being tested?
- Cebranopadol 400 ug and Cebranopadol 200 ug
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 279 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Sep 2024to 30 Dec 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Scheduled to undergo full abdominoplasty procedure without liposuction or other collateral procedures, using anesthesiologic and surgical procedures planned as described in this protocol.
- Must be able to adhere to the visit schedule, complete all study assessments, and protocol requirements including self-reported questionnaires.
Who cannot join
- 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.
- Subject has a current painful condition that could confound the interpretation of efficacy, safety or tolerability data in the study, in the opinion of the investigator.
- History of allergy, hypersensitivity or intolerance to any opioid analgesics or anesthetics, including opioid-induced nausea or vomiting.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
ALLEVIATE 1 Site 001110
Bellaire, Texas, 77401
ALLEVIATE 1 Site 001106
Little Rock, Arkansas, 72211
ALLEVIATE 1 Site 001112
Miami, Florida, 33014
ALLEVIATE 1 Site 001111
San Antonio, Texas, 78240
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain After Full Abdominoplasty
The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a Abdominoplasty.
Read the detailed description
This study is a Phase 3, multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain after Full Abdominoplasty. This study will be conducted in 3 phases: Screening, Treatment, and Follow-up.
- Conditions
- Acute Pain
- Being tested
- Cebranopadol 400 ug, Cebranopadol 200 ug, Placebo
- Keywords
- Abdominoplasty
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cebranopadol 400 ugDrug
Also called TRN-228
Once daily
Cebranopadol 200 ugDrug
Also called TRN-228
Once daily on Day 2
PlaceboDrug
Once daily for 2 days
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Cebranopadol 400 ug (once daily for 2 days) Receives: Drug: Cebranopadol 400 ug |
| Treatment B | Experimental | Cebranopadol 400 ug on Day 1; 200 ug on Day 2 Receives: Drug: Cebranopadol 400 ug; Drug: Cebranopadol 200 ug |
| Treatment C | Placebo comparator | Placebo (once daily for 2 days) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
Pain Numerical Rate Scale (NRS) area under the curve from 4 through 48 hours (AUC4-48)
Measured: 4-48 hours
Secondary outcomes (6)
Secondary Outcome Measure:
Pain Numerical Rate Scale (NRS) AUC4-24
Measured: 4-48 hours
Secondary Outcome Measure:
Number of doses of rescue medication
Measured: 48 hours
Secondary Outcome Measure:
Pain NRS AUC
Measured: 24-48 hours
Other Secondary Endpoint
Pain NRS
Measured: Partial AUCs: 4-12, 12-24, 24-36, 36-48, and 4-36 hours
Other Secondary Endpoint
Rescue Medication
Measured: Proportion of subjects who take at least 1 dose of rescue medication up to hours 12, 24, and 36
Other Secondary Endpoint
MOAA/S
Measured: peak sedation, total score and AUC4-48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2024
- Study start3 Sep 2024
- Primary completion30 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 279 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Harold S. Minkowitz, MD, Principal investigator, HD Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06545097
- Sponsor's protocol ID
- TRN-228-301
- Acronym
- ALLEVIATE1
- Status last verified
- Jan 2026
- First submitted
- 6 Aug 2024
- Last updated
- 22 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain After Full Abdominoplasty
- ClinicalTrials.gov ID
- NCT06545097
- Acronym / sponsor ID
- ALLEVIATE1 / TRN-228-301
- Conditions
- Acute Pain
- Keywords
- Abdominoplasty
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 279 participants (actual)
- Lead sponsor
- Tris Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Sep 2024 (actual)
- Primary completion
- 30 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 9 Aug 2024 (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 efficacy and safety of Cebranopadol for acute pain after a Abdominoplasty.
Detailed description
This study is a Phase 3, multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Cebranopadol for the Treatment of Moderate to Severe Acute Pain after Full Abdominoplasty. This study will be conducted in 3 phases: Screening, Treatment, and Follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment A | Experimental | Drug: Cebranopadol 400 ugCebranopadol 400 ug (once daily for 2 days) |
| Treatment B | Experimental | Drug: Cebranopadol 400 ug, Drug: Cebranopadol 200 ugCebranopadol 400 ug on Day 1; 200 ug on Day 2 |
| Treatment C | Placebo comparator | Drug: PlaceboPlacebo (once daily for 2 days) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled to undergo full abdominoplasty procedure without liposuction or other collateral procedures, using anesthesiologic and surgical procedures planned as described in this protocol.
- Must be able to adhere to the visit schedule, complete all study assessments, and protocol requirements including self-reported questionnaires.
Key exclusion criteria (3 listed)
- 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.
- Subject has a current painful condition that could confound the interpretation of efficacy, safety or tolerability data in the study, in the opinion of the investigator.
- History of allergy, hypersensitivity or intolerance to any opioid analgesics or anesthetics, including opioid-induced nausea or vomiting.
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 ugAlso: TRN-228Once daily | Drug | Treatment A, Treatment B |
| Cebranopadol 200 ugAlso: TRN-228Once daily on Day 2 | Drug | Treatment B |
| PlaceboOnce daily for 2 days | Drug | Treatment C |
Primary outcome
Primary Outcome Measure
Time frame: 4-48 hours
Pain Numerical Rate Scale (NRS) area under the curve from 4 through 48 hours (AUC4-48)
6 secondary outcomes
Secondary Outcome Measure:
Time frame: 4-48 hours
Secondary Outcome Measure:
Time frame: 48 hours
Secondary Outcome Measure:
Time frame: 24-48 hours
Other Secondary Endpoint
Time frame: Partial AUCs: 4-12, 12-24, 24-36, 36-48, and 4-36 hours
Other Secondary Endpoint
Time frame: Proportion of subjects who take at least 1 dose of rescue medication up to hours 12, 24, and 36
Other Secondary Endpoint
Time frame: peak sedation, total score and AUC4-48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2026.
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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. This study is not recruiting at the moment.
Harold S. Minkowitz, MD principal investigator
HD Research
4 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 and Cebranopadol 200 ug in people with Acute Pain, run by Tris Pharma, Inc. at 4 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 22 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 4-48 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 22 Jan 2026.