Risk of Major Adverse Cardiovascular Events for Naldemedine and Other Medications for Opioid Induced Constipation in Adults With Chronic Non-Cancer Pain

Opioid-induced Constipation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03720613
• Other study ID #: 1711V9241
• Status: Recruiting
• Start date: January 4, 2019
• Est. completion date: November 1, 2030

Study information

• Verified date: February 2022
• Source: BioDelivery Sciences International
• Contact: Todd Kunkel
• Phone: 913-940-1789
• Email: tkunkel[@]bdsi.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34532
• Est. completion date: November 1, 2030
• Est. primary completion date: November 1, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Opioid-Induced Constipation

Intervention

Drug:
• Naldemedine
0.2 mg tablet once a day at any time with or without food
• Lubiprostone
0.024 mg twice a day [adjust dose based on liver function]
• Naloxegol
25 mg tablet once a day in morning, 1 hour before or 2 hours after food

Locations

Country	Name	City	State
United States	Research Site	Wilmington	Delaware

Sponsors (2)

Lead Sponsor	Collaborator
BioDelivery Sciences International	HealthCore, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with a Major Adverse Cardiovascular Event	A composite of major adverse cardiovascular events, cardiovascular (CV) death, nonfatal myocardial infarction (MI), and non-fatal stroke.	5 years
Secondary	Number of Participants with Cardiovascular Death		5 years
Secondary	Number of Participants with Nonfatal Myocardial Infarction		5 years
Secondary	Number of Participants with Nonfatal Stroke		5 years