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
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Bethesda North TriHealth Hospital | Cincinnati | Ohio |
Lead Sponsor | Collaborator |
---|---|
TriHealth Inc. |
United States,
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
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 |
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