Opioid Induced ConstipationNCT02813369
Naloxegol Health Outcome Post Authorisation Safety Study
An observational study of Opioid Induced Constipation, run by Kyowa Kirin Pharmaceutical Development Ltd at 2 sites in 2 countries.
Trial summary
This post-authorization observational safety study (PASS) monitors clinically important identified and potential risks within a cohort of patients treated with naloxegol, including the occurrence of bowel perforation, acute myocardial infarction (MI), stroke, cardiovascular (CV)-specific mortality, all-cause… 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?
- naloxegol and non-PAMORA laxative
- How many people
- 10,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Sep 2016to Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Patients in the targeted European countries who receive prescriptions for naloxegol will be identified for inclusion in the naloxegol inception cohort, while patients in these countries who receive a prescription for a non-PAMORA laxative will be identified for inclusion in the concurrent reference cohort. All patients in this study will be ≥18 years of age; have ≥1 year of continuous data available; have exposure to current, regular opioid use; and have no prior exposure to PAMORA laxatives alvimopan, methylnaltrexone, or naloxone + opioid combination (including fixed-dose combinations).
Who may be able to join
- 1. Patient receives a new prescription for naloxegol or a non-PAMORA laxative. (Note: Only non-PAMORA laxatives that are approved/marketed in the European Union at the time naloxegol is authorized are permitted.)
Who cannot join
- Patients <18 years of age on cohort entry date
- Patients with <1 year of continuous data available prior to cohort entry date
- Patients without exposure to current regular opioid use defined by >30 days of opioid exposure within the 180 days prior to and inclusive of the cohort entry date
- Patients with evidence of a cancer indicator (diagnosis or treatment) prior to cohort entry date
- Exposure to PAMORA laxatives, alvimopan, methylnaltrexone, or naloxone + opioid combination (including fixed-dose combinations) prior to cohort entry date
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: An Observational Post-Authorisation Safety Study (PASS) of MOVENTIG® (Naloxegol) Among Patients Aged 18 Years and Older Treated With Opioids Chronically
This post-authorization observational safety study (PASS) monitors clinically important identified and potential risks within a cohort of patients treated with naloxegol, including the occurrence of bowel perforation, acute myocardial infarction (MI), stroke, cardiovascular (CV)-specific mortality, all-cause mortality, hypertension, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity. This study is part of a broader post-marketing commitment to augment routine evaluation of the safety profile of naloxegol in clinical practice.
Read the detailed description
The overall research goal for this study is to provide additional data to characterize the safety of naloxegol in the indicated population, grouped by cancer or non-cancer, and within at-risk vulnerable non-cancer populations identified in the naloxegol risk management plan (RMP) by describing type and frequency of identified and potential risks (including bowel perforation, acute MI, stroke, CV-specific mortality, all-cause mortality, hypertension, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity) in patients ≥18 years of age who were treated with opioids chronically and subsequently treated with naloxegol in routine post-authorization use.
The primary objective of the study is to assess the incidence risk of bowel perforation, acute MI, stroke, all-cause mortality, and hypertension in patients treated with naloxegol (Naloxegol Inception Cohort, (NIC)), grouped by cancer or non cancer, a Concurrent Reference Cohort (CRC) by cancer or non-cancer, and by pre-specified non-cancer sub-populations that include patients aged ≥65 years, pregnant patients, patients with prior CV, patients with prior renal or hepatic impairment, patients with concurrent methadone use, and patients with concurrent use of cytochrome P450 (CYP) 3A inhibitors/inducer or P-glycoprotein (Pgp) modulators.
An exploratory objective of the study is to assess the incidence risk of CV-specific mortality, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity in patients treated with naloxegol (NIC) grouped by cancer and non cancer, a CRC grouped by cancer or non cancer, and by pre-specified non-cancer sub-populations that include patients aged ≥65 years, pregnant patients, patients with prior cardiovascular risk, patients with prior renal or hepatic impairment, patients with concurrent methadone use, and patients with concurrent use of CYP3A inhibitors/inducer or Pgp modulators.
- Conditions
- Opioid Induced Constipation
- Being tested
- naloxegol, non-PAMORA laxative
- 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.
naloxegolDrug
non-interventional study where patients are exposed to naloxegol during normal clinical practice
non-PAMORA laxativeDrug
non-interventional study where patients are exposed to non-peripherally acting mu-opioid receptor antagonist (PAMORA) laxative
| Study group | Role | What they receive |
|---|---|---|
| naloxegol | patients exposed to naloxegol Receives: Drug: naloxegol | |
| non-PAMORA laxative | patient exposed to non-peripherally acting mu-opioid receptor antagonist (PAMORA) laxative Receives: Drug: non-PAMORA laxative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence (yes/no) of bowel perforation
Presence of a diagnostic or procedure code
Measured: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence (yes/no) of acute MI
Presence of a diagnostic code for acute MI, a diagnostic code for electrocardiogram supportive of MI or cardiac enzyme lab tests with positive results
Measured: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence (yes/no) of stroke
Presence of a diagnostic code for cerebral, cerebellar haemorrhage or infarction, cerebral embolism, stroke or cerebrovascular accident
Measured: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence (yes/no) of all-cause mortality
Record of death
Measured: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence (yes/no) of hypertension
Presence of a hypertension (HT) diagnostic code where no record of HT or treatment for HT was observed in the baseline, or a record of change in HT treatment type or dose from baseline was observed.
Measured: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Secondary outcomes (6)
Presence of (yes/no) CV-specific mortality
Record of death that indicates the cause was a CV event
Measured: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of (yes/no) opioid withdrawal
Presence of a diagnosis or symptom code
Measured: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of (yes/no) abdominal pain
Presence of a diagnosis or symptom code
Measured: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of (yes/no) diarrhea
Presence of a diagnosis or symptom code
Measured: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of (yes/no) syncope
Presence of a diagnosis code
Measured: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of (yes/no) change in pain severity
At least a doubling in opioid dose based on the morphine milligram equivalents (MME) from baseline
Measured: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionNov 2021
- Study completionNov 2021
Why it stopped: Not feasible to reach the required number of patient cases by the defined end of data collection milestone (Q4 2022) knowing that the study completion was planned by the end of 2023
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
- Retrospective
- Enrolment
- 10,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813369
- Sponsor's protocol ID
- D3820R00009
- Status last verified
- Jul 2024
- First submitted
- 7 Jun 2016
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Post-Authorisation Safety Study (PASS) of MOVENTIG® (Naloxegol) Among Patients Aged 18 Years and Older Treated With Opioids Chronically
- ClinicalTrials.gov ID
- NCT02813369
- Acronym / sponsor ID
- D3820R00009
- Conditions
- Opioid Induced Constipation
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Not feasible to reach the required number of patient cases by the defined end of data collection milestone (Q4 2022) knowing that the study completion was planned by the end of 2023
- Enrolment
- 10,000 participants (actual)
- Lead sponsor
- Kyowa Kirin Pharmaceutical Development LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2016 (actual)
- Primary completion
- Nov 2021 (actual)
- Study completion
- Nov 2021 (actual)
- First posted
- 27 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This post-authorization observational safety study (PASS) monitors clinically important identified and potential risks within a cohort of patients treated with naloxegol, including the occurrence of bowel perforation, acute myocardial infarction (MI), stroke, cardiovascular (CV)-specific mortality, all-cause mortality, hypertension, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity. This study is part of a broader post-marketing commitment to augment routine evaluation of the safety profile of naloxegol in clinical practice.
Detailed description
The overall research goal for this study is to provide additional data to characterize the safety of naloxegol in the indicated population, grouped by cancer or non-cancer, and within at-risk vulnerable non-cancer populations identified in the naloxegol risk management plan (RMP) by describing type and frequency of identified and potential risks (including bowel perforation, acute MI, stroke, CV-specific mortality, all-cause mortality, hypertension, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity) in patients ≥18 years of age who were treated with opioids chronically and subsequently treated with naloxegol in routine post-authorization use.
The primary objective of the study is to assess the incidence risk of bowel perforation, acute MI, stroke, all-cause mortality, and hypertension in patients treated with naloxegol (Naloxegol Inception Cohort, (NIC)), grouped by cancer or non cancer, a Concurrent Reference Cohort (CRC) by cancer or non-cancer, and by pre-specified non-cancer sub-populations that include patients aged ≥65 years, pregnant patients, patients with prior CV, patients with prior renal or hepatic impairment, patients with concurrent methadone use, and patients with concurrent use of cytochrome P450 (CYP) 3A inhibitors/inducer or P-glycoprotein (Pgp) modulators.
An exploratory objective of the study is to assess the incidence risk of CV-specific mortality, opioid withdrawal, abdominal pain, diarrhea, syncope, and change in pain severity in patients treated with naloxegol (NIC) grouped by cancer and non cancer, a CRC grouped by cancer or non cancer, and by pre-specified non-cancer sub-populations that include patients aged ≥65 years, pregnant patients, patients with prior cardiovascular risk, patients with prior renal or hepatic impairment, patients with concurrent methadone use, and patients with concurrent use of CYP3A inhibitors/inducer or Pgp modulators.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| naloxegol | – | Drug: naloxegolpatients exposed to naloxegol |
| non-PAMORA laxative | – | Drug: non-PAMORA laxativepatient exposed to non-peripherally acting mu-opioid receptor antagonist (PAMORA) laxative |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients in the targeted European countries who receive prescriptions for naloxegol will be identified for inclusion in the naloxegol inception cohort, while patients in these countries who receive a prescription for a non-PAMORA laxative will be identified for inclusion in the concurrent reference cohort. All patients in this study will be ≥18 years of age; have ≥1 year of continuous data available; have exposure to current, regular opioid use; and have no prior exposure to PAMORA laxatives alvimopan, methylnaltrexone, or naloxone + opioid combination (including fixed-dose combinations).
Key inclusion criteria (1 listed)
- 1. Patient receives a new prescription for naloxegol or a non-PAMORA laxative. (Note: Only non-PAMORA laxatives that are approved/marketed in the European Union at the time naloxegol is authorized are permitted.)
Key exclusion criteria (5 listed)
- Patients <18 years of age on cohort entry date
- Patients with <1 year of continuous data available prior to cohort entry date
- Patients without exposure to current regular opioid use defined by >30 days of opioid exposure within the 180 days prior to and inclusive of the cohort entry date
- Patients with evidence of a cancer indicator (diagnosis or treatment) prior to cohort entry date
- Exposure to PAMORA laxatives, alvimopan, methylnaltrexone, or naloxone + opioid combination (including fixed-dose combinations) prior to cohort entry date
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| naloxegolnon-interventional study where patients are exposed to naloxegol during normal clinical practice | Drug | naloxegol |
| non-PAMORA laxativenon-interventional study where patients are exposed to non-peripherally acting mu-opioid receptor antagonist (PAMORA) laxative | Drug | non-PAMORA laxative |
Primary outcome
Presence (yes/no) of bowel perforation
Time frame: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of a diagnostic or procedure code
Presence (yes/no) of acute MI
Time frame: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of a diagnostic code for acute MI, a diagnostic code for electrocardiogram supportive of MI or cardiac enzyme lab tests with positive results
Presence (yes/no) of stroke
Time frame: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of a diagnostic code for cerebral, cerebellar haemorrhage or infarction, cerebral embolism, stroke or cerebrovascular accident
Presence (yes/no) of all-cause mortality
Time frame: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Record of death
Presence (yes/no) of hypertension
Time frame: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of a hypertension (HT) diagnostic code where no record of HT or treatment for HT was observed in the baseline, or a record of change in HT treatment type or dose from baseline was observed.
6 secondary outcomes
Presence of (yes/no) CV-specific mortality
Time frame: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of (yes/no) opioid withdrawal
Time frame: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of (yes/no) abdominal pain
Time frame: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of (yes/no) diarrhea
Time frame: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of (yes/no) syncope
Time frame: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Presence of (yes/no) change in pain severity
Time frame: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years
Results and safety
The study was stopped early (reason given: Not feasible to reach the required number of patient cases by the defined end of data collection milestone (Q4 2022) knowing that the study completion was planned by the end of 2023). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Opioid Induced Constipation, run by Kyowa Kirin Pharmaceutical Development Ltd at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Not feasible to reach the required number of patient cases by the defined end of data collection milestone (Q4 2022) knowing that the study completion was planned by the end of 2023). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence (yes/no) of bowel perforation (time frame: Can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 7 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2024.