Health TrialsbyHealthPanel

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

ConditionOpioid-induced Constipation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBioDelivery Sciences International

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

The study population will include new users of naldemedine or one of the comparator OIC medications (lubiprostone or naloxegol) who satisfy all of the inclusion criteria and none of the exclusion criteria.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Naldemedine

    Drug

    0.2 mg tablet once a day at any time with or without food

  • Lubiprostone

    Drug

    0.024 mg twice a day \[adjust dose based on liver function\]

  • Naloxegol

    Drug

    25 mg tablet once a day in morning, 1 hour before or 2 hours after food

Treatment groups

34,532 Participants
are divided into 3 treatment groups
Group A: Naldemedine1 intervention
Group B: Lubiprostone1 intervention
Group C: Naloxegol1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with a Major Adverse Cardiovascular Event

A composite of major adverse cardiovascular events, cardiovascular (CV) death, nonfatal myocardial infarction (MI), and non-fatal stroke; participants with major adverse cardiovascular events will be identified using claims data and the national death index.

Time frame
5 years

Secondary outcomes

1

Number of Participants with Cardiovascular Death

Cardiovascular death is defined by the underlying cause of death and will include death from acute MI, sudden cardiac death, heart failure, stroke, cardiovascular procedure, cardiovascular hemorrhage, and other cardiovascular causes. Cardiovascular death will be identified using claims data and the national death index.

Time frame
5 years
2

Number of Participants with Nonfatal Myocardial Infarction

Participants with nonfatal myocardial infarction will be identified using claims data.

Time frame
5 years
3

Number of Participants with Nonfatal Stroke

Participants with nonfatal stroke will be identified using claims data.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

BioDelivery Sciences International

Lead sponsor

HealthCore, Inc.

Collaborator

Source ClinicalTrials.gov
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