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Naloxegol and Opioid-induced Constipation

Primary Purpose

Constipation, Constipation Drug Induced

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Naloxegol 25 MG
Placebo pill
Sponsored by
TriHealth Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring opioid-induced constipation (OIC)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bethesda North TriHealth HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Naloxegol

Placebo

Arm Description

naloxegol 25 mg pill

placebo pill

Outcomes

Primary Outcome Measures

Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Time to substantial bowel movement
Time to bowel movement of Type 2 or higher on the Bristol stool chart

Secondary Outcome Measures

Rescue medications
Amount of rescue medications
Rescue medications
Amount of rescue medications
Rescue medications
Amount of rescue medications
Rescue medications
Amount of rescue medications
Rescue medications
Amount of rescue medications

Full Information

First Posted
October 17, 2017
Last Updated
April 29, 2022
Sponsor
TriHealth Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03316859
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
December 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
TriHealth Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation, Constipation Drug Induced
Keywords
opioid-induced constipation (OIC)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Naloxegol
Arm Type
Experimental
Arm Description
naloxegol 25 mg pill
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
placebo pill
Intervention Type
Drug
Intervention Name(s)
Naloxegol 25 MG
Other Intervention Name(s)
Movantik
Intervention Description
Naloxegol 25 mg administered 1 hour pre-operatively
Intervention Type
Other
Intervention Name(s)
Placebo pill
Intervention Description
Placebo pill administered 1 hour pre-operatively
Primary Outcome Measure Information:
Title
Time to substantial bowel movement
Description
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Time Frame
Post-operative day 1
Title
Time to substantial bowel movement
Description
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Time Frame
Post-operative day 2
Title
Time to substantial bowel movement
Description
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Time Frame
Post-operative day 3
Title
Time to substantial bowel movement
Description
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Time Frame
Post-operative day 4
Title
Time to substantial bowel movement
Description
Time to bowel movement of Type 2 or higher on the Bristol stool chart
Time Frame
Post-operative day 5
Secondary Outcome Measure Information:
Title
Rescue medications
Description
Amount of rescue medications
Time Frame
Post-operative day 1
Title
Rescue medications
Description
Amount of rescue medications
Time Frame
Post-operative day 2
Title
Rescue medications
Description
Amount of rescue medications
Time Frame
Post-operative day 3
Title
Rescue medications
Description
Amount of rescue medications
Time Frame
Post-operative day 4
Title
Rescue medications
Description
Amount of rescue medications
Time Frame
Post-operative day 5
Other Pre-specified Outcome Measures:
Title
Length of stay
Description
CVICU length of stay
Time Frame
Post-operative day 1
Title
Length of stay
Description
CVICU length of stay
Time Frame
Post-operative day 2
Title
Length of stay
Description
CVICU length of stay
Time Frame
Post-operative day 3
Title
Length of stay
Description
CVICU length of stay
Time Frame
Post-operative day 4
Title
Length of stay
Description
CVICU length of stay
Time Frame
Post-operative day 5

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyn LaMar, BS
Phone
513-865-5072
Email
Jocelyn_LaMar@trihealth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer Perkins
Phone
513-865-1415
Email
jennifer_perkins@trihealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Scott McCardle, MD
Organizational Affiliation
Bethesda North TriHealth Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bethesda North TriHealth Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jocelyn LaMar, BS
Phone
513-865-5072
Email
Jocelyn_LaMar@trihealth.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24896818
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.
Results Reference
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PubMed Identifier
25135384
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.
Results Reference
background
PubMed Identifier
26136838
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.
Results Reference
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Naloxegol and Opioid-induced Constipation

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