Acute PainPhase 3ALLEVIATE2NCT06423703
A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy
A Phase 3 study testing Cebranopadol and Oxycodone IR in people with Acute Pain, run by Tris Pharma, Inc. at 10 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 bunionectomy. 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 and Oxycodone IR
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 10 sitesUnited States
- Study dates
- 18 Jul 2024to 31 Jan 2025
- 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 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.
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.
- 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.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
ALLEVIATE 2 Site 001102
Atlanta, Georgia, 30331
Alleviate 2 001113
Houston, Texas, 77043
ALLEVIATE 2 Site 001106
Little Rock, Arkansas, 72211
ALLEVIATE 2 Site 001104
McAllen, Texas, 78501
ALLEVIATE 2 Site 001107
Overland Park, Kansas, 66212
ALLEVIATE 2 Site 001105
Pasadena, Maryland, 21122
ALLEVIATE 2 Site 001101
Salt Lake City, Utah, 84107
ALLEVIATE 2 Site 001111
San Antonio, Texas, 78240
ALLEVIATE 2 Site 001108
Sheffield, Alabama, 35660
ALLEVIATE 2 Site 001103
Tampa, Florida, 33613
About this study
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
The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a bunionectomy.
Read the 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
- Acute Pain
- Being tested
- Cebranopadol, Oxycodone IR, Placebo Only, Placebo
- Keywords
- Bunionectomy
- Medical subject headings
- Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CebranopadolDrug
Also called TRN-228
once daily for 3 days
Oxycodone IRDrug
Also called oxycodone immediate release
four times per day for 3 days
Placebo OnlyDrug
four times per day for 3 days
PlaceboDrug
three times per day for 3 days
| Study group | Role | What they receive |
|---|---|---|
| Cebranopadol | Experimental | once daily for 3 days Receives: Drug: Cebranopadol; Drug: Placebo |
| Oxycodone IR | Active comparator | four times per day for 3 days Receives: Drug: Oxycodone IR |
| Placebo | Placebo comparator | four times per day for 3 days Receives: Drug: Placebo Only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain NRS area under the curve: cebranopadol vs. placebo
Measured: 2-48 hours
Secondary outcomes (3)
Proportion of subjects who require opioid rescue medication
Measured: 1-7 Days
Global Assessment of Satisfaction
Measured: 1-7 Days
Total oxycodone rescue consumption
Measured: 1-7 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2024
- Study start18 Jul 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tris Pharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Todd M Bertoch, MD, Principal investigator, Cenexel JBR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06423703
- Sponsor's protocol ID
- TRN-228-302
- Acronym
- ALLEVIATE2
- Status last verified
- Jan 2026
- First submitted
- 16 May 2024
- Last updated
- 26 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 26 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06423703
- Acronym / sponsor ID
- ALLEVIATE2 / TRN-228-302
- Conditions
- Acute Pain
- Keywords
- Bunionectomy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Tris Pharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 18 Jul 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 21 May 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 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.
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 |
|---|---|---|
| Cebranopadol | Experimental | Drug: Cebranopadol, Drug: Placeboonce daily for 3 days |
| Oxycodone IR | Active comparator | Drug: Oxycodone IRfour times per day for 3 days |
| Placebo | Placebo comparator | Drug: Placebo Onlyfour times per day for 3 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 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 (8 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.
- 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.
- Surgical, postsurgical, or anesthetic complication that could confound the interpretation of efficacy, safety, or tolerability data in the study.
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 |
|---|---|---|
| CebranopadolAlso: TRN-228once daily for 3 days | Drug | Cebranopadol |
| Oxycodone IRAlso: oxycodone immediate releasefour times per day for 3 days | Drug | Oxycodone IR |
| Placebo Onlyfour times per day for 3 days | Drug | Placebo |
| Placebothree times per day for 3 days | Drug | Cebranopadol |
Primary outcome
Pain NRS area under the curve: cebranopadol vs. placebo
Time frame: 2-48 hours
3 secondary outcomes
Proportion of subjects who require opioid rescue medication
Time frame: 1-7 Days
Global Assessment of Satisfaction
Time frame: 1-7 Days
Total oxycodone rescue consumption
Time frame: 1-7 Days
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 26 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.
Todd M Bertoch, MD principal investigator
Cenexel JBR
10 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 and Oxycodone IR in people with Acute Pain, run by Tris Pharma, Inc. at 10 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 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: finished, as of the sponsor's last update on 26 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 10 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?
Pain NRS area under the curve: cebranopadol vs. placebo (time frame: 2-48 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 26 Jan 2026.