Naloxegol US PMR CV Safety.

NCT02813356 | Unknown FDA Drug

• 2 other identifiers: D3820R00008EUPAS18201
• Study Type: observational
• Target: 8,800
• Locations: 1 country
• Sites: 2

Brief Summary

The overall research goal for this study is to provide additional data to characterize the safety of naloxegol in patients aged 18 years and older who do not have a diagnosis of cancer and who are treated with opioids chronically

Conditions

Opioid Induced Constipation

Outcome Measures

Primary Outcomes (1)

• major adverse cardiovascular events

  while exposed to naloxegol or comparator exposure, composite of major adverse cardiovascular events which includes cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke

  can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 8 years

Study Arms (2)

naloxegol

patients exposed to naloxegol

Drug: naloxegol

non-PAMORA

patients exposed to non-peripherally acting mu-opioid antagonist

Drug: non-PAMORA

Interventions

naloxegol DRUG

non-interventional study where naloxegol is prescribed during normal clinical practice

naloxegol

non-PAMORA DRUG

non-interventional study where patients are exposed to non-peripherally acting mu-opioid antagonists during the normal course of clinical practice

non-PAMORA

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients in this study will be 18 years of age or older, and they will have had at least 6 months of continuous data available before they enter one of the new-user cohorts. During the 6-month baseline period before cohort entry, they will have received at least 90 days of dispensed opioids, of which in the 60 days before cohort entry there were at least 30 days of opioids dispensed at an average of at least 30 morphine equivalent units (MEQ) per day. Patients will have no evidence of active cancer; they will have no evidence in the electronic record of MACE; they will not have received methylnatrexone bromide for subcutaneous injection. At the time of the index dispensing of naloxegol or comparison drug, cohort members will furthermore be current users of a dispensed opioid.

You may qualify if:

• Patient receives a new dispensing of naloxegol, lubiprostone/linaclotide, or an oral NNPAMORA. A new dispensing is one that occurs with no dispensing for the same drug having occurred in the preceding 182 days. A patient only qualifies once under this criterion for any drug.
• Patients 18 years of age or older at the index date
• Continuous availability of data for at least 183 days immediately before and including the index date
• days of opioid dispensed in the 183 days before and including the index date of which at least 30 days of opioid dispensed at at least 30 MEQ/day in the 60 days before and including index date
• Current users of a dispensed opioid, meaning that the interval between index study drug dispensing and at least 1 prior opioid dispensing is less than the days supply associated with the opioid dispensing

You may not qualify if:

• Any medical care associated with a diagnosis of cancer in the 183 days before and including the index date; a diagnosis of cancer for this purpose is any diagnostic code of International Classification of Diseases, 9th revision (ICD-9) in the range 140-208 "Malignant neoplasms …" or of the 10th revision (ICD-10) in the range C00-C96, "Malignant neoplasms"
• Dispensing of methylnaltrexone for subcutaneous injection in the 183 days before and including the index date
• Indication in the electronic records of the occurrence of MACE in the 183 days before and including the index date; see Section 9.3.2 "MACE" for screening criteria

Sponsors & Collaborators

• Valinor Pharma LLC: lead

Study Sites (2)

Research Site

Wilmington, Delaware, 19803, United States

Location

Research Site

Hines, Illinois, 60141, United States

Location

MeSH Terms

Conditions

Opioid-Induced Constipation

Interventions

naloxegol

Condition Hierarchy (Ancestors)

Constipation; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Beth Nordstrom

  Evidera

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2016
• First Posted: June 27, 2016
• Study Start: June 24, 2016
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: May 15, 2023

Record last verified: 2023-05

Locations

US (2)