Clinical trial · Observational
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
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
NCT03720613CI-TRIAL-00085868recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Opioid-induced Constipation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lubiprostone | Drug | — | UNRESOLVED |
| Naldemedine | Drug | — | UNRESOLVED |
| Naloxegol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Naldemedine
- description
- Patients with chronic non-cancer pain who initiated naldemedine treatment for opioid-induced constipation.
- interventionNames
- Drug: Naldemedine
- label
- Lubiprostone
- description
- Patients with chronic non-cancer pain who initiated lubiprostone treatment for opioid-induced constipation.
- interventionNames
- Drug: Lubiprostone
- label
- Naloxegol
- description
- Patients with chronic non-cancer pain who initiated naloxegol treatment for opioid-induced constipation.
- interventionNames
- Drug: Naloxegol
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.