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

Conditions

• Opioid-induced Constipation

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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.

Key Dates

Start date

Jan 4, 2019

Status verified

Feb 2025

Primary completion

Nov 1, 2030

Completion

Nov 1, 2030

Study Design

Enrollment

34,532 participants (estimated)

Arms

• Arm: Naldemedine
  Patients with chronic non-cancer pain who initiated naldemedine treatment for opioid-induced constipation.
• Arm: Lubiprostone
  Patients with chronic non-cancer pain who initiated lubiprostone treatment for opioid-induced constipation.
• Arm: Naloxegol
  Patients with chronic non-cancer pain who initiated naloxegol treatment for opioid-induced constipation.

Primary Outcome Measure

Number of Participants with a Major Adverse Cardiovascular Event [ Time Frame: 5 years ]

Central Contacts

• Todd Kunkel
  913-940-1789
  [email protected]
• Tom Smith
  [email protected]

Locations (1)

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