Opioid Induced ConstipationNCT02813148
Naloxegol Drug Utilization Post Authorisation Safety Study
An observational study of Opioid Induced Constipation, run by Kyowa Kirin Pharmaceutical Development Ltd at 4 sites in 4 countries.
Trial summary
This post-authorization observational safety study determines the characteristics of patients prescribed naloxegol at time of first prescription and treatment patterns of naloxegol in follow-up in the United Kingdom (UK), Norway, Sweden, and Germany. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Opioid Induced Constipation
- What is being tested?
- Naloxegol
- How many people
- 17,254 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Aug 2015to Jan 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients in the targeted countries who are newly prescribed naloxegol will be identified for inclusion. Patients analyzed in this study will be those who have at least 12 months of continuous data available prior to first prescription. The number of patients who do not have at least 12 months of prior data will be reported for completeness.
Who may be able to join
- The patient has at least 1 prescription of naloxegol in his/her medical record anytime during the study period.
- The patient has at least 12 months of computerized records prior to the first prescription of naloxegol (index date)
Who cannot join
- No exclusion criteria will be applied
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: An Observational Post-Authorization Safety Study (PASS) of MOVENTIG® (Naloxegol) Drug Utilization in Selected European Populations
This post-authorization observational safety study determines the characteristics of patients prescribed naloxegol at time of first prescription and treatment patterns of naloxegol in follow-up in the United Kingdom (UK), Norway, Sweden, and Germany.
Read the detailed description
The overall research questions for this study are: 1) What are the demographic, clinical, and treatment characteristics (including dose) at baseline of patients prescribed naloxegol in real-world practice (including the use of naloxegol in non-indicated populations)? and 2) What are the treatment patterns of naloxegol utilization during follow-up?
Primary objectives:
- To describe the characteristics of patients prescribed naloxegol at time of first prescription (demographics, targeted comorbidities, targeted comedications, provider characteristics, and indication characteristics).
- To describe any of the following treatment patterns:
- Discontinuation of naloxegol (permanently during the observation period)
- Switching from naloxegol to other drug(s) potentially used by patients with opioid induced constipation (OIC)
- Prescription of other drug(s) potentially used by patients with OIC in the same period when naloxegol is prescribed (augmentation)
- Restart in the prescription of naloxegol (after temporary discontinuation or treatment holiday)
- Continuous treatment with naloxegol during the study period
- Change in dosing
Exploratory objective:
- To identify predictors of length of naloxegol use
- Conditions
- Opioid Induced Constipation
- Being tested
- Naloxegol
- 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 of drug utilization
What is being measured
The primary outcome is the main question the study is designed to answer.
discontinuation
Presence (yes/no) of a patient discontinuing naloxegol (i.e. permanently during the observation period)
Measured: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Switching
Presence (yes/no) of a patient switching from naloxegol to other drug(s) potentially used by patients with opioid induced constipation (OIC)
Measured: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Augmentation
Presence (yes/no) of a patient augmenting therapy with a prescription of other drug(s) potentially used by patients with OIC in the same period when naloxegol is prescribed
Measured: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Restart
Presence (yes/no) of a patient restarting the prescription of naloxegol (after temporary discontinuation or treatment holiday)
Measured: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Continuous Use
Presence (yes/no) of a patient continuously treated with naloxegol during the study period
Measured: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Dose Change
Presence (yes/no) of a patient changing dosing of naloxegol
Measured: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2016 (estimated)
- Study startAug 2015
- Primary completionJun 2019
- Study completionJan 2020
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
- 17,254 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rob Swain, Study director, Kyowa Kirin, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02813148
- Sponsor's protocol ID
- D3820R00006
- Status last verified
- Jul 2024
- First submitted
- 6 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-Authorization Safety Study (PASS) of MOVENTIG® (Naloxegol) Drug Utilization in Selected European Populations
- ClinicalTrials.gov ID
- NCT02813148
- Acronym / sponsor ID
- D3820R00006
- Conditions
- Opioid Induced Constipation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17,254 participants (actual)
- Lead sponsor
- Kyowa Kirin Pharmaceutical Development LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2015 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 24 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 determines the characteristics of patients prescribed naloxegol at time of first prescription and treatment patterns of naloxegol in follow-up in the United Kingdom (UK), Norway, Sweden, and Germany.
Detailed description
The overall research questions for this study are: 1) What are the demographic, clinical, and treatment characteristics (including dose) at baseline of patients prescribed naloxegol in real-world practice (including the use of naloxegol in non-indicated populations)? and 2) What are the treatment patterns of naloxegol utilization during follow-up?
Primary objectives:
- To describe the characteristics of patients prescribed naloxegol at time of first prescription (demographics, targeted comorbidities, targeted comedications, provider characteristics, and indication characteristics).
- To describe any of the following treatment patterns:
- Discontinuation of naloxegol (permanently during the observation period)
- Switching from naloxegol to other drug(s) potentially used by patients with opioid induced constipation (OIC)
- Prescription of other drug(s) potentially used by patients with OIC in the same period when naloxegol is prescribed (augmentation)
- Restart in the prescription of naloxegol (after temporary discontinuation or treatment holiday)
- Continuous treatment with naloxegol during the study period
- Change in dosing
Exploratory objective:
- To identify predictors of length of naloxegol use
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in the targeted countries who are newly prescribed naloxegol will be identified for inclusion. Patients analyzed in this study will be those who have at least 12 months of continuous data available prior to first prescription. The number of patients who do not have at least 12 months of prior data will be reported for completeness.
Key inclusion criteria (2 listed)
- The patient has at least 1 prescription of naloxegol in his/her medical record anytime during the study period.
- The patient has at least 12 months of computerized records prior to the first prescription of naloxegol (index date)
Key exclusion criteria (1 listed)
- No exclusion criteria will be applied
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 of drug utilization | Drug | – |
Primary outcome
discontinuation
Time frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Presence (yes/no) of a patient discontinuing naloxegol (i.e. permanently during the observation period)
Switching
Time frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Presence (yes/no) of a patient switching from naloxegol to other drug(s) potentially used by patients with opioid induced constipation (OIC)
Augmentation
Time frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Presence (yes/no) of a patient augmenting therapy with a prescription of other drug(s) potentially used by patients with OIC in the same period when naloxegol is prescribed
Restart
Time frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Presence (yes/no) of a patient restarting the prescription of naloxegol (after temporary discontinuation or treatment holiday)
Continuous Use
Time frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Presence (yes/no) of a patient continuously treated with naloxegol during the study period
Dose Change
Time frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years
Presence (yes/no) of a patient changing dosing of naloxegol
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Rob Swain study director
Kyowa Kirin, Inc.
4 sites in 4 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 4 sites in 4 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 2 inclusion and 1 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: finished, 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 4 sites in Germany, Norway, Sweden, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
discontinuation (time frame: can occur anytime through study completion, given no fixed follow-up timepoints, which can range from 1 day to 3 years). The study lists 6 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.