Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
RecruitingNCT03720613
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Risk of Major Adverse Cardiovascular Events Among Users of Naldemedine Compared With Other Medications Used for Opioid Induced Constipation in Adult Patients With Chronic Non-Cancer Pain in a Healthcare Claims Database
- Conditions
- Opioid-induced Constipation
- Interventions
- Drug: Naldemedine
- Drug: Lubiprostone
- Drug: Naloxegol
- Sponsor
- BioDelivery Sciences International
- Collaborators
- HealthCore, Inc.
- Start date
- 2019-01-04
- Primary completion
- 2029-06-30
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT03720613