Recruiting
Phase 3

Cebranopadol

Sponsor:

Adneuris Therapeutics, Inc.

Code:

NCT07845071

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Cebranopadol 400 ug

Study Details

Brief summary:

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

Conditions

Pain

Study ID

NCT07845071

Start date

Sep, 2026

Status verified date

Sep, 2026

Completion date

Feb, 2027

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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:

  • 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.

Study Design

Enrollment

160 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Cebranopadol 400 ug

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

Primary outcome measure

  • Sum of pain intensity differences through 48 hours (SPID48) [ Time Frame: From 0 through 48 hours ]

Central Contacts and Locations

Central contacts

Study Director, Adneuris Therapeutics

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

Emilio Quetglas, MD

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

Locations

Adneuris Site 001104

Recruiting

McAllen, Texas, United States, 78501

More Information

Sponsor

Adneuris Therapeutics, Inc.

Last update posted

Sep 28, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Adneuris Therapeutics, Inc. on 2026-09-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.