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NCT03720613 · ClinicalTrials.gov registry record
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
A clinical trial of Opioid-induced Constipation, sponsored by BioDelivery Sciences International.
- Recruiting
- Registry status
- 34,532
- Enrollment target
- 1
- Study location
NCT03720613: Recruiting study of Opioid-induced Constipation, sponsored by BioDelivery Sciences International.
NCT03720613 is a study of Opioid-induced Constipation that is actively recruiting participants, run by BioDelivery Sciences International. The registered enrollment target is 34,532 participants, above the 326-participant average among 5 other Opioid-induced Constipation trials with a reported enrollment target (10493% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03720613, a study of Opioid-induced Constipation, is actively recruiting participants, sponsored by BioDelivery Sciences International.
- RECRUITING
- Registry status
- 34,532 participants
- Enrollment target
- 1
- Study location
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Naldemedine
- DRUG Lubiprostone
- DRUG Naloxegol
Study Locations (1)
Delaware
- Research Site - Wilmington
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34,532 participants |
| Start Date | 2019-01-04 |
| Est. Completion | 2030-11-01 |
What NCT03720613 shows while recruiting
NCT03720613 is an observational study that tracks outcomes without assigning an intervention. Its 34,532 participants enrollment target places it among the larger protocols in the corpus, above the 326-participant average among 5 other Opioid-induced Constipation trials with a reported enrollment target (10493% higher).
The record links to 1 condition, with Opioid-induced Constipation appearing as the primary indexed condition, and to 3 interventions - of which Naldemedine is the first listed.
NCT03720613 reports a single indexed study location in Delaware.
Frequently Asked Questions
What is clinical trial NCT03720613 about?
NCT03720613 is a clinical study titled "Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation". 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.
What is the current status of trial NCT03720613?
This trial is currently recruiting. The enrollment target is 34,532 participants. The study started on 2019-01-04. Estimated completion is 2030-11-01.
What conditions does trial NCT03720613 study?
This clinical trial studies the following conditions: Opioid-induced Constipation.
What interventions are being tested in trial NCT03720613?
The interventions under investigation include: Naldemedine (DRUG), Lubiprostone (DRUG), Naloxegol (DRUG).
Who is sponsoring clinical trial NCT03720613?
This trial is sponsored by BioDelivery Sciences International, which has 17 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03720613 being conducted?
This trial has 1 study location across Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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