UnknownNot Applicable

Naloxegol US PMR CV Safety.

United States8,800 participantsStarted 2016-06-24

Plain-language 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

Who can participate

SexALL

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Inclusion criteria

✓. 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
✓. 90 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

Exclusion criteria

✕. 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

What they're measuring

major adverse cardiovascular events

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

Trial details

NCT IDNCT02813356

SponsorValinor Pharma LLC

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2023-12-31

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