Opioid-induced ConstipationKYONALNCT04173858
Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol
An observational study of Opioid-induced Constipation, run by Kyowa Kirin Farmacéutica S.L.U. at 1 site in Spain.
Trial summary
Opioid-induced constipation (OIC) is a common feature in patients treated with strong opioids. Such medication is often prescribed together with a laxative (osmotic, emollient), with effectiveness depending on the individual patient. 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
- Type of treatment
- Pill or oral medicine
- How many people
- 126 participants
- Where
- 1 siteSpain
- Study dates
- 21 Sep 2017to 31 Oct 2019
- 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: Ambulatory oncology patients in Spain with diagnosis of OIC.
Who may be able to join
- Diagnosis of Cancer
- Treatment with opioids
- OIC symptoms
- Inadequate response to laxatives
- Karnofsky equal or above 50
- Ambulatory
- Must be able to complete questionnaire forms
Who cannot join
- Hypersensitivity to Naloxegol or vehicle
- Suspicion or high risk of gastrointestinal block
- High risk of GI perforation
- Severe liver failure
- Pregnancy or breastfeeding
- Use of potent CYP3A4 inhibitors
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol. A One-year Follow-up Study
Opioid-induced constipation (OIC) is a common feature in patients treated with strong opioids. Such medication is often prescribed together with a laxative (osmotic, emollient), with effectiveness depending on the individual patient. Peripherally-acting, mu-opioid receptor antagonists (PAMORAs), such as Naloxegol, have proven to be effective against OIC in patients with inadequate response to laxatives without reducing opioid analgesic effect. However, evidence regarding efficacy and safety on patients with cancer is still scarce. The objective of this study was to analyze the efficacy of naloxegol in a real-world setting by assessing Quality of Life outcomes, and to obtain data on its safety in the long term in patients with cancer.
- Conditions
- Opioid-induced Constipation
- Being tested
- Naloxegol
- Keywords
- Naloxegol, 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
25 mg oral naloxegol once daily.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Patients with confirmed opioid-induced constipation diagnosis and inadequate response to laxatives. Receives: Drug: Naloxegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Quality of Life
Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire
Measured: 12 months
Secondary outcomes (4)
Assessment of Constipation Symptoms
Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire
Measured: 15 days
Assessment of Constipation Symptoms
Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire
Measured: 1 month
Assessment of Constipation Symptoms
Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire
Measured: 3 months
Assessment of Constipation Symptoms
Patient Assessment of Constipation Symptoms (PAC-SYM) Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start21 Sep 2017
- Primary completion31 Oct 2019
- Study completion31 Oct 2019
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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Farmacéutica S.L.U.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173858
- Sponsor's protocol ID
- KYO-NAL-2017-01
- Acronym
- KYONAL
- Status last verified
- Nov 2019
- First submitted
- 18 Nov 2019
- Last updated
- 22 Nov 2019
- 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 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Quality of Life of Patients With Opioid-induced Constipation Under Treatment With Naloxegol. A One-year Follow-up Study
- ClinicalTrials.gov ID
- NCT04173858
- Acronym / sponsor ID
- KYONAL / KYO-NAL-2017-01
- Conditions
- Opioid-induced Constipation
- Keywords
- Naloxegol, PAMORA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Kyowa Kirin Farmacéutica S.L.U.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2017 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 22 Nov 2019 (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.
Opioid-induced constipation (OIC) is a common feature in patients treated with strong opioids. Such medication is often prescribed together with a laxative (osmotic, emollient), with effectiveness depending on the individual patient. Peripherally-acting, mu-opioid receptor antagonists (PAMORAs), such as Naloxegol, have proven to be effective against OIC in patients with inadequate response to laxatives without reducing opioid analgesic effect. However, evidence regarding efficacy and safety on patients with cancer is still scarce. The objective of this study was to analyze the efficacy of naloxegol in a real-world setting by assessing Quality of Life outcomes, and to obtain data on its safety in the long term in patients with cancer.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental | – | Drug: NaloxegolPatients with confirmed opioid-induced constipation diagnosis and inadequate response to laxatives. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Ambulatory oncology patients in Spain with diagnosis of OIC.
Key inclusion criteria (7 listed)
- Diagnosis of Cancer
- Treatment with opioids
- OIC symptoms
- Inadequate response to laxatives
- Karnofsky equal or above 50
Key exclusion criteria (7 listed)
- Hypersensitivity to Naloxegol or vehicle
- Suspicion or high risk of gastrointestinal block
- High risk of GI perforation
- Severe liver failure
- Pregnancy or breastfeeding
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 |
|---|---|---|
| Naloxegol25 mg oral naloxegol once daily. | Drug | Experimental |
Primary outcome
Assessment of Quality of Life
Time frame: 12 months
Patient Assessment of Constipation Quality of Life (PAC-QoL) Questionnaire
4 secondary outcomes
Assessment of Constipation Symptoms
Time frame: 15 days
Assessment of Constipation Symptoms
Time frame: 1 month
Assessment of Constipation Symptoms
Time frame: 3 months
Assessment of Constipation Symptoms
Time frame: 6 months
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 22 Nov 2019.
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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.
1 site in 1 country: 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 Farmacéutica S.L.U. at 1 site in Spain.
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 7 inclusion and 7 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 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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?
Assessment of Quality of Life (time frame: 12 months). 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 22 Nov 2019.