Naloxegol and Opioid-induced Constipation
A Prospective Randomized, Double-Blind Study to Evaluate the Addition of Naloxegol to the Pre-Op Regimen of the Cardiac Surgery Patient and Its Effect on Opioid-Induced Constipation
1 other identifier
interventional
280
1 country
1
Brief Summary
This is a double-blind, randomized, placebo-controlled trial to examine the effectiveness of adding one 25mg dose of naloxegol to the cardiac surgery pre-operative regimen.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2017
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2017
CompletedFirst Posted
Study publicly available on registry
October 20, 2017
CompletedStudy Start
First participant enrolled
November 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMay 5, 2022
June 1, 2021
5.1 years
October 17, 2017
April 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Post-operative day 1
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Post-operative day 2
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Post-operative day 3
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Post-operative day 4
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Post-operative day 5
Secondary Outcomes (5)
Rescue medications
Post-operative day 1
Rescue medications
Post-operative day 2
Rescue medications
Post-operative day 3
Rescue medications
Post-operative day 4
Rescue medications
Post-operative day 5
Other Outcomes (5)
Length of stay
Post-operative day 1
Length of stay
Post-operative day 2
Length of stay
Post-operative day 3
- +2 more other outcomes
Study Arms (2)
Naloxegol
EXPERIMENTALnaloxegol 25 mg pill
Placebo
PLACEBO COMPARATORplacebo pill
Interventions
Naloxegol 25 mg administered 1 hour pre-operatively
Eligibility Criteria
You may qualify if:
- Scheduled to undergo elective cardiac surgery at Bethesda North TriHealth Hospital
- Admitted to Bethesda North TriHealth Hospital CVICU post-surgery
You may not qualify if:
- Medically unstable
- Cognitive deficits that impair the patient's ability to understand the informed consent
- Language barriers
- Patient has a documented diagnosis of one of the following: Crohn's disease; Ulcerative Colitis; History of bowel surgery that will impact absorption of study drug (as deemed by physician); History of small bowel obstruction
- Chronic constipation requiring subject to take one of the following medications on a daily basis prior to time of consent: Linzess, Trulance, Amitza, Senna/Senokot, Colace, Dulcolax, Miralax, Metamucil
- Patients on following medications prior to time of consent: Diltiazem, Verapamil, Amiodarone, Ketoconazole, Clarithromycin/ erythromycin, Antivirals
- Conditions that present an increased risk of bowel perforation (as determined by the physician)
- Pre-existing diagnosis of opioid-induced constipation AND receiving naloxegol as a treatment by their physician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- TriHealth Inc.lead
Study Sites (1)
Bethesda North TriHealth Hospital
Cincinnati, Ohio, 45242, United States
Related Publications (3)
Chey WD, Webster L, Sostek M, Lappalainen J, Barker PN, Tack J. Naloxegol for opioid-induced constipation in patients with noncancer pain. N Engl J Med. 2014 Jun 19;370(25):2387-96. doi: 10.1056/NEJMoa1310246. Epub 2014 Jun 4.
PMID: 24896818BACKGROUNDDePriest AZ, Miller K. Oxycodone/Naloxone: role in chronic pain management, opioid-induced constipation, and abuse deterrence. Pain Ther. 2014 Jun;3(1):1-15. doi: 10.1007/s40122-014-0026-2. Epub 2014 May 6.
PMID: 25135384BACKGROUNDNelson AD, Camilleri M. Chronic opioid induced constipation in patients with nonmalignant pain: challenges and opportunities. Therap Adv Gastroenterol. 2015 Jul;8(4):206-20. doi: 10.1177/1756283X15578608.
PMID: 26136838BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Scott McCardle, MD
Bethesda North TriHealth Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2017
First Posted
October 20, 2017
Study Start
November 6, 2017
Primary Completion
December 1, 2022
Study Completion
December 1, 2022
Last Updated
May 5, 2022
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share