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

ConditionPain
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorAdneuris Therapeutics, Inc.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Cebranopadol 400 ug

    Drug

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

Treatment groups

160 Participants
are divided into 1 treatment group
Group A: CebranopadolExperimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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