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

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Primary and study completion moved earlier from Nov 1, 2030 to Jun 30, 2029
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 1 of 3 entries
  2. Secondary endpoints: details revised at 3 of 3 entries
    • Study description expanded, about 86 words
    • Study title shortened, about 6 words
    v7
  3. Primary and study completion dates: Nov 1, 2025 to Nov 1, 2030v6
  4. Re-verified, no change to tracked fieldsv5
  5. Lead sponsor: Shionogi to BioDelivery Sciences International
    • Collaborators expanded, about 2 words
    v4
Show 2 earlier versionsHide 2 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jan 30, 2019 to Jan 4, 2019
    v3
  2. Start date: Oct 31, 2018 to Jan 30, 2019v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT03720613
Lead Sponsor BioDelivery Sciences International
Collaborators: HealthCore, Inc.
Conditions
(from sponsor)		 Opioid-induced Constipation
Related terms Opioid-Induced Constipation
Enrollment 34,532 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov