Assessing cardiovascular risks of naldemedine and other medications for opioid-induced constipation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the risk of major adverse cardiovascular events (MACE) among new users of naldemedine compared to users of lubiprostone and naloxegol, which are also used for opioid-induced constipation (OIC). The study will utilize multiple databases linked to medical records and the National Death Index to monitor the uptake of these medications and assess safety outcomes. The monitoring phase will continue until a sufficient number of patients is accrued for comparative analyses in the safety assessment phase.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* At least one dispensing of naldemedine or lubiprostone or naloxegol without prior use in the database of either medication (index date)
* At least two dispensings of opioids within six months prior to and including the index date, with at least a combined 31 cumulative days supply
* At least 18 years of age or older on the index date
* At least six months of continuous health plan coverage that includes medical and pharmacy benefits prior to and including the index date

Exclusion Criteria:

* Any acute MACE (non-fatal MI or non-fatal stroke) within six months before or on the index date
* Any cancer treatment or cancer pain diagnosis within six months before or on the index date
* Prior use of methylnaltrexone, alvimopan or naloxegol within six months before or on the index date

Where it's running

• Research Site
  Wilmington, Delaware, United States Recruiting

Study contacts

• Principal investigator: Stephen Lanes — HealthCore, Inc.
• Study coordinator: Todd Kunkel
• Email: tkunkel@bdsi.com
• Phone: 913-940-1789

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Self-administered acupressure for constipation in adult psychiatric inpatients

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• Timing of opioid administration and breathing changes after surgery

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.