Naldemedine for Opioid-Induced Constipation

Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation

Recruiting Observational Study
Opioid-induced Constipation
No Placebo Group Every participant receives an active treatment — no one gets a placebo. No Study Drug Researchers observe your health over time — no experimental treatment is given.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Study type
Observational
Participants needed
34,532 (estimated)
Sponsor
BioDelivery Sciences International · Industry
Who this trial is looking for

This trial is looking for patients experiencing constipation caused by opioid use. Participants will compare the effects of naldemedine to other medications for this condition.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am at least 18 years old
  • I have received at least one prescription for naldemedine, lubiprostone, or naloxegol
  • I have taken opioids at least two times in the past six months
  • I have had enough opioid medication for at least 31 days in total
  • I have been continuously covered by a health plan for at least six months

You may not be able to join if

  • I have had a heart attack or stroke in the past 6 months
  • I have received treatment for cancer or have been diagnosed with cancer pain in the past 6 months
  • I have used methylnaltrexone, alvimopan, or naloxegol in the past 6 months

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.

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About This Trial

The research objective is to characterize the risk of a major adverse cardiovascular event (MACE) among new users of naldemedine versus new users of lubiprostone and new users of naloxegol as comparator opioid induced constipation (OIC) medications.

Trial Locations
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Eligibility Criteria
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 su…
Contacts

Todd Kunkel

913-940-1789

tkunkel@bdsi.com

CONTACT

Tom Smith

tsmith@bdsi.com

CONTACT