Opioid-induced ConstipationNCT03720613
Risk of Major Adverse Cardiovascular Events for Naldemedine & Other Medications for Opioid Induced Constipation
An observational study of Opioid-induced Constipation, run by BioDelivery Sciences International at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid-induced Constipation
- What is being tested?
- Naldemedine, Lubiprostone and Naloxegol
- Type of treatment
- Pill or oral medicine
- How many people
- 34,532 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2019to 30 Jun 2029
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include new users of naldemedine or one of the comparator OIC medications (lubiprostone or naloxegol) who satisfy all of the inclusion criteria and none of the exclusion criteria.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Tom Smith contact
United States1 site, 1 recruiting
- Recruiting
Research Site
Wilmington, Delaware, 19801
About this study
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
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.
Read the detailed description
This is a prevalent new user cohort study conducted using multiple databases linkable to medical records and the National Death Index (NDI) to assess MACE risk among adult patients with chronic non-cancer pain receiving naldemedine or a comparator OIC medication. The uptake of naldemedine and comparator OIC medications will be monitored for each database annually until a sufficient number of patients to support the comparative analyses in the safety assessment phase is accrued. The safety assessment phase will commence at the conclusion of the monitoring phase.
- Conditions
- Opioid-induced Constipation
- Being tested
- Naldemedine, Lubiprostone, Naloxegol
- Keywords
- naloxegol, major adverse cardiovascular event (MACE), opioid induced constipation (OIC), lubiprostone, naldemedine
- Medical subject headings
- Opioid-Induced Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaldemedineDrug
Also called Symproic®
0.2 mg tablet once a day at any time with or without food
LubiprostoneDrug
Also called Amitiza®
0.024 mg twice a day [adjust dose based on liver function]
NaloxegolDrug
Also called Movantik®
25 mg tablet once a day in morning, 1 hour before or 2 hours after food
| Study group | Role | What they receive |
|---|---|---|
| Naldemedine | Patients with chronic non-cancer pain who initiated naldemedine treatment for opioid-induced constipation. Receives: Drug: Naldemedine | |
| Lubiprostone | Patients with chronic non-cancer pain who initiated lubiprostone treatment for opioid-induced constipation. Receives: Drug: Lubiprostone | |
| Naloxegol | Patients with chronic non-cancer pain who initiated naloxegol treatment for opioid-induced constipation. Receives: Drug: Naloxegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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; participants with major adverse cardiovascular events will be identified using claims data and the national death index.
Measured: 5 years
Secondary outcomes (3)
Number of Participants with Cardiovascular Death
Cardiovascular death is defined by the underlying cause of death and will include death from acute MI, sudden cardiac death, heart failure, stroke, cardiovascular procedure, cardiovascular hemorrhage, and other cardiovascular causes. Cardiovascular death will be identified using claims data and the national death index.
Measured: 5 years
Number of Participants with Nonfatal Myocardial Infarction
Participants with nonfatal myocardial infarction will be identified using claims data.
Measured: 5 years
Number of Participants with Nonfatal Stroke
Participants with nonfatal stroke will be identified using claims data.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2018
- Study start4 Jan 2019
- Primary completion30 Jun 2029 (estimated)
- Study completion30 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid-induced ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 34,532 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioDelivery Sciences International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- HealthCore, Inc.
- Responsible party
- Sponsor
- Investigators
- Stephen Lanes, Principal investigator, HealthCore, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03720613
- Sponsor's protocol ID
- 1711V9241
- Status last verified
- Sep 2026
- First submitted
- 24 Oct 2018
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No