Opioid Induced ConstipationNACASYNCT03638440
Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC.
An observational study of Opioid Induced Constipation, run by Kyowa Kirin Pharmaceutical Development Ltd at 10 sites in 10 countries.
Trial summary
This is a single-arm, open label, multinational, multicentre, prospective, real world observational study of Naloxegol in adult subjects with Opioid Induced Constipation (OIC) in patients receiving Naloxegol in routine clinical practice. 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
- How many people
- 183 participants
- Where
- 10 sitesin 10 countries
- Study dates
- 16 Aug 2018to 5 Mar 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 18 years and older
- All sexes
- Adult, Older adult
Study population: This study will involve 315 patients (out-patients or in-patients) with Opioid Induced Constipation (OIC) from 32 European hospitals.
Who may be able to join
- Patient ≥ 18 years old
- Patient who is receiving treatment with opioids for at least 4 weeks, and is expected to remain on opioids for duration of study
- Patient with opioid-induced constipation
- Patient in whom the clinician plans treatment with Naloxegol according to routine clinical practice (Naloxegol SmPC recommends that all currently used maintenance laxative therapy should be halted)
- Signing of the informed consent
Who cannot join
- Patients with colorectal cancer
Trial locations and contacts
10 sites in 10 countries.
10 sites in 10 countries
About this study
Official title: Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With Opioid Induced Constipation.
This is a single-arm, open label, multinational, multicentre, prospective, real world observational study of Naloxegol in adult subjects with Opioid Induced Constipation (OIC) in patients receiving Naloxegol in routine clinical practice. Subjects who are receiving Naloxegol (prescribed by their physician according to the SmPC, which recommends that all currently used maintenance laxative therapy should be halted) during the enrolment period may be eligible for enrolment into the study.
Read the detailed description
The objective of this study is to assess the safety and efficacy of Naloxegol in a real world setting in cancer patients.
The primary safety end point is the incidence of adverse events leading to study discontinuation.
The primary efficacy end point is the response rate assessed in the 4 week observation period. Response is defined as three or more bowel movements (without the use of rescue laxative treatment in the previous 24 hours) per week and an increase of one or more bowel movements over baseline.
- Conditions
- Opioid Induced Constipation
- Being tested
- Naloxegol
- Keywords
- Opioid Induced Constipation, Naloxegol, Peripherally Acting Mu-Opioids Receptor Antagonist (PAMORA)
- 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
Also called Moventig
Naloxegol is a PEGylated derivative of the μ-opioid receptor antagonist naloxone
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the safety and efficacy of Naloxegol in a real world setting in cancer patients.
Response rate
Measured: 4 week treatment period
Secondary outcomes (9)
Proportion of patients that have a BFI score change of ≥12 points at the end of the study treatment
Bowel Function Index (BFI) score change of ≥12 points
Measured: 4 week observation period
Proportion of patients that have a BFI score <30 at the end of the study (patients adequately treated).
Bowel Function Index (BFI) score <30
Measured: 4 week observation period
Time to the first post-dose bowel movement
Time to first post-dose bowel movement
Measured: 4 week observation period
Change in stool consistency
Bristol stool scale (BSS)
Measured: 4 week observation period
Change in Patient Assessment of Constipation (PAC-QOL)
Quality of Life Questionnaire
Measured: 4 week observation period
Incidence of overall adverse events, including SAEs
Adverse Events, including SAEs
Measured: 4 week observation period
Analgesic treatment interruptions/dose adjustments
Dose adjustments
Measured: 4 week observation period
Naloxegol treatment interruptions/dose adjustments
Dose adjustments
Measured: 4 week observation period
Patient satisfaction (PGI-I)
Patient Global Impression of Improvement (PGI-I)
Measured: 4 week observation period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start16 Aug 2018
- Primary completion5 Mar 2020
- Study completion5 Mar 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
- Other
- Time perspective
- Prospective
- Enrolment
- 183 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Apices Soluciones S.L.
- Responsible party
- Sponsor
- Investigators
- Andrew Davies, MD, Principal investigator, Royal Surrey County Hospital NHS Foundation TrustJan Tack, MD, Principal investigator, University Hospital KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03638440
- Sponsor's protocol ID
- NACASY
- Acronym
- NACASY
- Status last verified
- Jun 2024
- First submitted
- 7 Aug 2018
- Last updated
- 17 Jun 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With Opioid Induced Constipation.
- ClinicalTrials.gov ID
- NCT03638440
- Acronym / sponsor ID
- NACASY / NACASY
- Conditions
- Opioid Induced Constipation
- Keywords
- Opioid Induced Constipation, Naloxegol, Peripherally Acting Mu-Opioids Receptor Antagonist (PAMORA)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 183 participants (actual)
- Lead sponsor
- Kyowa Kirin Pharmaceutical Development LtdIndustry (pharma, biotech, devices)
- Collaborators
- Apices Soluciones S.L.
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 20 Aug 2018 (actual)
- 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 is a single-arm, open label, multinational, multicentre, prospective, real world observational study of Naloxegol in adult subjects with Opioid Induced Constipation (OIC) in patients receiving Naloxegol in routine clinical practice. Subjects who are receiving Naloxegol (prescribed by their physician according to the SmPC, which recommends that all currently used maintenance laxative therapy should be halted) during the enrolment period may be eligible for enrolment into the study.
Detailed description
The objective of this study is to assess the safety and efficacy of Naloxegol in a real world setting in cancer patients.
The primary safety end point is the incidence of adverse events leading to study discontinuation.
The primary efficacy end point is the response rate assessed in the 4 week observation period. Response is defined as three or more bowel movements (without the use of rescue laxative treatment in the previous 24 hours) per week and an increase of one or more bowel movements over baseline.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will involve 315 patients (out-patients or in-patients) with Opioid Induced Constipation (OIC) from 32 European hospitals.
Key inclusion criteria (5 listed)
- Patient ≥ 18 years old
- Patient who is receiving treatment with opioids for at least 4 weeks, and is expected to remain on opioids for duration of study
- Patient with opioid-induced constipation
- Patient in whom the clinician plans treatment with Naloxegol according to routine clinical practice (Naloxegol SmPC recommends that all currently used maintenance laxative therapy should be halted)
- Signing of the informed consent
Key exclusion criteria (1 listed)
- Patients with colorectal cancer
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 |
|---|---|---|
| NaloxegolAlso: MoventigNaloxegol is a PEGylated derivative of the μ-opioid receptor antagonist naloxone | Drug | – |
Primary outcome
To assess the safety and efficacy of Naloxegol in a real world setting in cancer patients.
Time frame: 4 week treatment period
Response rate
9 secondary outcomes
Proportion of patients that have a BFI score change of ≥12 points at the end of the study treatment
Time frame: 4 week observation period
Proportion of patients that have a BFI score <30 at the end of the study (patients adequately treated).
Time frame: 4 week observation period
Time to the first post-dose bowel movement
Time frame: 4 week observation period
Change in stool consistency
Time frame: 4 week observation period
Change in Patient Assessment of Constipation (PAC-QOL)
Time frame: 4 week observation period
Incidence of overall adverse events, including SAEs
Time frame: 4 week observation period
Analgesic treatment interruptions/dose adjustments
Time frame: 4 week observation period
Naloxegol treatment interruptions/dose adjustments
Time frame: 4 week observation period
Patient satisfaction (PGI-I)
Time frame: 4 week observation period
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 17 Jun 2024.
Related trials for Opioid Induced Constipation
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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.
Andrew Davies, MD principal investigator
Royal Surrey County Hospital NHS Foundation Trust
Jan Tack, MD principal investigator
University Hospital KU Leuven
10 sites in 10 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 10 sites in 10 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 5 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 17 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Denmark, Finland, France, Germany, Greece and 5 more countries. 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?
To assess the safety and efficacy of Naloxegol in a real world setting in cancer patients. (time frame: 4 week treatment period). 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 17 Jun 2024.