Recruiting

Naldemedine with Medications

Sponsor:

BioDelivery Sciences International

Code:

NCT03720613

Conditions

Opioid-induced Constipation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Naldemedine

Lubiprostone

Naloxegol

Study Details

Brief 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.

Conditions

Opioid-induced Constipation

Study ID

NCT03720613

Start date

Jan 4, 2019

Status verified date

Feb, 2025

Completion date

Nov 1, 2030

Anticipated

Primary completion date

Nov 1, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

34532 participants

Anticipated

Interventions and Outcome Measures

Arms

Naldemedine

Patients with chronic non-cancer pain who initiated naldemedine treatment for opioid-induced constipation.

Lubiprostone

Patients with chronic non-cancer pain who initiated lubiprostone treatment for opioid-induced constipation.

Naloxegol

Patients with chronic non-cancer pain who initiated naloxegol treatment for opioid-induced constipation.

Interventions

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

Primary outcome measure

  • Number of Participants with a Major Adverse Cardiovascular Event [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Todd Kunkel

913-940-1789tkunkel@bdsi.com

Tom Smith

tsmith@bdsi.com

Locations

Research Site

Recruiting

Wilmington, Delaware, United States, 19801

More Information

Sponsor

BioDelivery Sciences International

Last update posted

Feb 12, 2025

Last verified

Feb, 2025

Keywords

  • naloxegol
  • major adverse cardiovascular event (MACE)
  • opioid induced constipation (OIC)
  • lubiprostone
  • naldemedine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by BioDelivery Sciences International on 2025-02-12.