Clinical trial NCT03316859: Naloxegol and Opioid-induced Constipation
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Constipation
Constipation Drug Induced
Keywords: opioid-induced constipation (OIC)
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2017-10-20
Enrollment: 280
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: 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-op regimen. There will be 140 subjects per study group. The patient and treating physician/nurse will be blinded as to which group the subject is assigned. On the day of surgery, subjects in both groups will complete a questionnaire to assess compliance with prescribed pre-operative regimen. Subjects in both groups will receive post-operative bowel regimen in the cardiovascular intensive care unit (CVICU) according to current standard of care, including procedures for rescue medications for constipation prevention and induction of a bowel movement.

Eligibility criteria: Inclusion Criteria:

* Scheduled to undergo elective cardiac surgery at Bethesda North TriHealth Hospital
* Admitted to Bethesda North TriHealth Hospital CVICU post-surgery

Exclusion Criteria:

* 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

Primary outcomes:
measure: Time to substantial bowel movement
timeFrame: Post-operative day 1
measure: Time to substantial bowel movement
timeFrame: Post-operative day 2
measure: Time to substantial bowel movement
timeFrame: Post-operative day 3
measure: Time to substantial bowel movement
timeFrame: Post-operative day 4
measure: Time to substantial bowel movement
timeFrame: Post-operative day 5
Secondary outcomes:
measure: Rescue medications
timeFrame: Post-operative day 1
measure: Rescue medications
timeFrame: Post-operative day 2
measure: Rescue medications
timeFrame: Post-operative day 3
measure: Rescue medications
timeFrame: Post-operative day 4
measure: Rescue medications
timeFrame: Post-operative day 5
Other outcomes:
measure: Length of stay
timeFrame: Post-operative day 1
measure: Length of stay
timeFrame: Post-operative day 2
measure: Length of stay
timeFrame: Post-operative day 3
measure: Length of stay
timeFrame: Post-operative day 4
measure: Length of stay
timeFrame: Post-operative day 5
Locations:
city: Cincinnati
country: United States
facility: Bethesda North TriHealth Hospital
state: Ohio
Study officials:
affiliation: Bethesda North TriHealth Hospital
name: Scott McCardle, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: DePriest 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.
citation: Nelson 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.