Constipation, Signs and Symptoms, DigestivePhase 1NCT02099591
Phase I Pharmacokinetics and Safety Study of Naloxegol in Paediatric OIC Patients
A Phase 1 study testing Naloxegol in people with Constipation, Signs and Symptoms, Digestive, run by Kyowa Kirin Pharmaceutical Development Ltd at 16 sites in 5 countries.
Trial summary
To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) or at risk of OIC. Read more about this study
- Who is it for?
- Ages 6 months to 18 years
- Conditions the study is for
- Constipation, Signs and Symptoms, Digestive
- What is being tested?
- Naloxegol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 16 sitesin 5 countries
- Study dates
- Nov 2014to Apr 2021
- Phase
- Phase 1
- 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 6 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Main inclusion criteria, patient with:
- malignant or non-malignant pain who are receiving or (are about to receive) acute or chronic treatment with opioids
- newly diagnosed constatipation, with history of constipation treated with laxatives or expected to develop constipation after opioid treatment
- ability to be present in the clinic for at least 10 hours following the first study drug for blood sampling and to return at 24 hours for blood sampling.
Main exclusion criteria:
- Current acute or chronic use of methadone
- History of an neoplasm or an ongoing gastrointestinal-related issue
- Signs or symptoms of gastrointestinal obstruction
- History of prolonged neutropenia or thrombocytopenia with clinical sequelae.
- Patients currently receiving the first cycle of chemotherapy
Trial locations and contacts
16 sites in 5 countries.
16 sites in 5 countries
Spain5 sites
Pediatric Oncology Unit Hospital Vall d'Hebron
Barcelona, 08035
Hospital Infantil Universitario Nino Jesus
Madrid, 28046
Hospital Universitario Madrid Sanchinarro
Madrid, 28050
Unidad de Hematología y Oncología Pediátrica - Hospital Universitario HM Monteprincipe
Madrid, 28660
Hospital Universitario Virgen de la Arrixaca
Murcia, 03191
United Kingdom5 sites
The Leeds Teaching Hosptial NHS Trust
Leeds, LS1 3EX
Alder Hey Children's Hospital
Liverpool, L12 2AP
Royal Marsden Hospital
London, SW3 6JJ
Nottingham Children's Hospital
Nottingham, NG7 2UH
Oxford University Hospitals NHS Foundation Trust
Oxford, OX3 9DU
Norway3 sites
Haukeland Universitetssykehus
Bergen, 5021
Oslo University Hospital - Rikshospitalet
Oslo, 0372
St. Olavs Hospital
Trondheim, 7006
Israel2 sites
Rambam Medical Center, Oncology Institute
Haifa, 31096
Schneider Children Medical Center
Petah Tikva, 49202
About this study
Official title: A Phase I, Open-Label, Multicentre Study to Assess the Pharmacokinetics and Safety of Naloxegol in Paediatric Patients Ages ≥ 6 Months to < 18 Years Receiving Treatment With Opioids
To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) or at risk of OIC.
- Being tested
- Naloxegol
- Keywords
- Constipation, Colonic Inertia, Dyschezia, Pharmacokinetics, Naloxegol, Paediatric, Opioids, Opioid induced constipation, OIC, Phase 1
- Medical subject headings
- Constipation, 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
Opioid Antagonist
| Study group | Role | What they receive |
|---|---|---|
| Age group: > = 12y to < 18y - Lower dose | Experimental | Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months. Receives: Drug: Naloxegol |
| Age group: > = 12y to < 18y - Higher dose | Experimental | Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months. Receives: Drug: Naloxegol |
| Age group: > = 6y to < 12y - Lower dose | Experimental | Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months. Receives: Drug: Naloxegol |
| Age group: > = 6y to < 12y - Higher dose | Experimental | Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months. Receives: Drug: Naloxegol |
| Age group: > = 6mo to < 6y - Lower dose | Experimental | Naloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months. Receives: Drug: Naloxegol |
| Age group: > = 6mo to < 6y - Higher dose | Experimental | Naloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months. Receives: Drug: Naloxegol |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterise the pharmacokinetics of naloxegol after single oral dose and through population pharmacokinetics in paediatric patients with opioid induced constipation
Measured: Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours
Secondary outcomes (4)
To characterise the pharmacokinetics of naloxegol after multiple, once-daily, oral dosing in paediatric opioid induced constipation patients who continue participation beyond Day 1
Measured: Day 7 (minimum 3 days of naloxegol treatment): pre-dose and 4 hours post-dose
Palatability of naloxegol liquid drug formulation
Measured: Day 1 and Day 2 after dose
Ability of the patient to swallow the tablet
Measured: Day 1 and Day 2 after dose
Clinical outcome measures by assessment of laxative use
Measured: From Day 1 until the End of treatment (26 week of study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2014 (estimated)
- Study startNov 2014
- Primary completionApr 2021
- Study completionApr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Constipation, Signs and Symptoms, DigestiveStudies 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyowa Kirin Pharmaceutical Development Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patrick Davies, Principal investigator, Nottingham Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099591
- Sponsor's protocol ID
- D3820C00016
- Other IDs
- UTN: U1111-1154-5575, 2013-003935-32
- Status last verified
- Jun 2024
- First submitted
- 13 Feb 2014
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- 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
- A Phase I, Open-Label, Multicentre Study to Assess the Pharmacokinetics and Safety of Naloxegol in Paediatric Patients Ages ≥ 6 Months to < 18 Years Receiving Treatment With Opioids
- ClinicalTrials.gov ID
- NCT02099591
- Acronym / sponsor ID
- D3820C00016
- Keywords
- Constipation, Colonic Inertia, Dyschezia, Pharmacokinetics, Naloxegol, Paediatric, Opioids, Opioid induced constipation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Kyowa Kirin Pharmaceutical Development LtdIndustry (pharma, biotech, devices)
- Study start
- Nov 2014 (actual)
- Primary completion
- Apr 2021 (actual)
- Study completion
- Apr 2021 (actual)
- First posted
- 31 Mar 2014 (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.
To characterize the pharmacokinetics (PK) of naloxegol after single oral dose and through population PK in paediatric patients with opioid induced constipation (OIC) or at risk of OIC.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Age group: > = 12y to < 18y - Lower dose | Experimental | Drug: NaloxegolNaloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months. |
| Age group: > = 12y to < 18y - Higher dose | Experimental | Drug: NaloxegolNaloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months. |
| Age group: > = 6y to < 12y - Lower dose | Experimental | Drug: NaloxegolNaloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months. |
| Age group: > = 6y to < 12y - Higher dose | Experimental | Drug: NaloxegolNaloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months. |
| Age group: > = 6mo to < 6y - Lower dose | Experimental | Drug: NaloxegolNaloxegol Dose equivalent to 12.5mg in adults which will be administered once daily for up to 6 months. |
| Age group: > = 6mo to < 6y - Higher dose | Experimental | Drug: NaloxegolNaloxegol Dose equivalent to 25mg in adults which will be administered once daily for up to 6 months. |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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: MoventigOpioid Antagonist | Drug | Age group: > = 12y to < 18y - Higher dose, Age group: > = 12y to < 18y - Lower dose, Age group: > = 6mo to < 6y - Higher dose, Age group: > = 6mo to < 6y - Lower dose, Age group: > = 6y to < 12y - Higher dose, Age group: > = 6y to < 12y - Lower dose |
Primary outcome
To characterise the pharmacokinetics of naloxegol after single oral dose and through population pharmacokinetics in paediatric patients with opioid induced constipation
Time frame: Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours
4 secondary outcomes
To characterise the pharmacokinetics of naloxegol after multiple, once-daily, oral dosing in paediatric opioid induced constipation patients who continue participation beyond Day 1
Time frame: Day 7 (minimum 3 days of naloxegol treatment): pre-dose and 4 hours post-dose
Palatability of naloxegol liquid drug formulation
Time frame: Day 1 and Day 2 after dose
Ability of the patient to swallow the tablet
Time frame: Day 1 and Day 2 after dose
Clinical outcome measures by assessment of laxative use
Time frame: From Day 1 until the End of treatment (26 week of study)
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.
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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.
Patrick Davies principal investigator
Nottingham Children's Hospital
16 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Naloxegol in people with Constipation, Signs and Symptoms, Digestive, run by Kyowa Kirin Pharmaceutical Development Ltd at 16 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 16 sites in Spain, United Kingdom, Norway, Israel, Denmark. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 characterise the pharmacokinetics of naloxegol after single oral dose and through population pharmacokinetics in paediatric patients with opioid induced constipation (time frame: Day 1 : Pre-dose (within 30 min prior to drug dosing), 0.5, 1, 2, 4, 6, 8, 10 and 24 hours). 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.