Naloxegol and Opioid-induced Constipation

Constipation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03316859
• Other study ID #: 17-020
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: November 6, 2017
• Est. completion date: December 1, 2022

Study information

• Verified date: June 2021
• Source: TriHealth Inc.
• Contact: Jocelyn LaMar, BS
• Phone: 513-865-5072
• Email: Jocelyn_LaMar[@]trihealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Constipation Drug Induced
• Opioid-Induced Constipation

Intervention

Drug:
• Naloxegol 25 MG
Naloxegol 25 mg administered 1 hour pre-operatively

Other:
• Placebo pill
Placebo pill administered 1 hour pre-operatively

Locations

Country	Name	City	State
United States	Bethesda North TriHealth Hospital	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
TriHealth Inc.

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of stay	CVICU length of stay	Post-operative day 1
Other	Length of stay	CVICU length of stay	Post-operative day 2
Other	Length of stay	CVICU length of stay	Post-operative day 3
Other	Length of stay	CVICU length of stay	Post-operative day 4
Other	Length of stay	CVICU length of stay	Post-operative day 5
Primary	Time to substantial bowel movement	Time to bowel movement of Type 2 or higher on the Bristol stool chart	Post-operative day 1
Primary	Time to substantial bowel movement	Time to bowel movement of Type 2 or higher on the Bristol stool chart	Post-operative day 2
Primary	Time to substantial bowel movement	Time to bowel movement of Type 2 or higher on the Bristol stool chart	Post-operative day 3
Primary	Time to substantial bowel movement	Time to bowel movement of Type 2 or higher on the Bristol stool chart	Post-operative day 4
Primary	Time to substantial bowel movement	Time to bowel movement of Type 2 or higher on the Bristol stool chart	Post-operative day 5
Secondary	Rescue medications	Amount of rescue medications	Post-operative day 1
Secondary	Rescue medications	Amount of rescue medications	Post-operative day 2
Secondary	Rescue medications	Amount of rescue medications	Post-operative day 3
Secondary	Rescue medications	Amount of rescue medications	Post-operative day 4
Secondary	Rescue medications	Amount of rescue medications	Post-operative day 5