COMPLETED

A Study of Cebranopadol for the Treatment of Acute Pain After Bunionectomy

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Conditions

Acute PainBunionectomy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the efficacy and safety of Cebranopadol for acute pain after a bunionectomy.

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

Quick Facts

Study Start:2024-07-18
Study Completion:2025-01-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06423703

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. * Surgical, postsurgical, or anesthetic complication that could confound the interpretation of efficacy, safety, or tolerability data in the study.
  2. * Deviation from the surgical, postsurgical, or anesthetic protocol that could confound the interpretation of efficacy, safety, or tolerability data in the study.
  3. * Evidence of hemodynamic instability or respiratory insufficiency.

Contacts and Locations

Principal Investigator

Todd M Bertoch, MD
PRINCIPAL_INVESTIGATOR
Cenexel JBR

Study Locations (Sites)

ALLEVIATE 2 Site 001108
Sheffield, Alabama, 35660
United States
ALLEVIATE 2 Site 001106
Little Rock, Arkansas, 72211
United States
ALLEVIATE 2 Site 001103
Tampa, Florida, 33613
United States
ALLEVIATE 2 Site 001102
Atlanta, Georgia, 30331
United States
ALLEVIATE 2 Site 001107
Overland Park, Kansas, 66212
United States
ALLEVIATE 2 Site 001105
Pasadena, Maryland, 21122
United States
Alleviate 2 001113
Houston, Texas, 77043
United States
ALLEVIATE 2 Site 001104
McAllen, Texas, 78501
United States
ALLEVIATE 2 Site 001111
San Antonio, Texas, 78240
United States
ALLEVIATE 2 Site 001101
Salt Lake City, Utah, 84107
United States

Collaborators and Investigators

Sponsor: Tris Pharma, Inc.

  • Todd M Bertoch, MD, PRINCIPAL_INVESTIGATOR, Cenexel JBR

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-07-18
Study Completion Date2025-01-31

Study Record Updates

Study Start Date2024-07-18
Study Completion Date2025-01-31

Terms related to this study

Keywords Provided by Researchers

  • Bunionectomy

Additional Relevant MeSH Terms

  • Acute Pain