Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
NCT ID: NCT05588323
Last Updated: 2025-04-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
24 participants
INTERVENTIONAL
2023-01-04
2026-06-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Cohort 1: ≥ 12 to < 18 Years
Participants will receive 0.05 milligrams (mg) to 0.2 mg naldemedine based on their body weight once daily for 7 days.
Naldemedine
Administered as an oral tablet (0.2 mg dose level only), or oral suspension (all dose levels)
Cohort 2: ≥ 6 to < 12 Years
Participants will receive 0.05 mg to 0.2 mg naldemedine based on their body weight once daily for 7 days.
Naldemedine
Administered as an oral tablet (0.2 mg dose level only), or oral suspension (all dose levels)
Cohort 3: ≥ 2 to < 6 Years
Participants will be enrolled in this cohort after the safety and PK data has been evaluated for cohorts 1 and 2.
Participants will receive 0.05 mg to 0.2 mg naldemedine based on their body weight once daily for 7 days.
Naldemedine
Administered as an oral tablet (0.2 mg dose level only), or oral suspension (all dose levels)
Interventions
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Naldemedine
Administered as an oral tablet (0.2 mg dose level only), or oral suspension (all dose levels)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with cancer or non-cancer pain who are receiving (or who are about to receive) acute or chronic treatment with opioids.
* Participants with either newly diagnosed constipation, a history of constipation treated with laxatives, or are expected to develop constipation after opioid treatment.
* Able to remain in the clinic for blood sampling for at least 12 hours following the first study intervention dose and are able to return for blood sampling at the 24-hour time point.
Weight
* Body mass index within approximately the 3rd to 97th percentile for their age according to the World Health Organization Child Growth Standards.
Exclusion Criteria
* History of a gastrointestinal (GI) neoplasm or an ongoing GI-related issue or any recent (within last 1 year) or planned GI tract surgery.
* Signs or symptoms of GI obstruction or participants with recurrent obstruction who may be at increased risk of GI perforation.
* Inability to eat/swallow or have need of a nasogastric tube.
* No bowel movements reported for 7 consecutive days at the time of obtaining informed consent or on the initial day of study intervention administration (Study Day 1).
* History of more than 1 week of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 neutropenia or thrombocytopenia with clinical sequelae.
* Participants who need mechanical ventilation.
* Severe CTCAE Grade 3 or above hepatic or renal impairment including end-stage renal disease requiring hemodialysis, as determined by the investigator.
* Progressive neurological disorders or potential disruption to the blood-brain barrier (for example, primary brain malignancies, central nervous system metastases, active multiple sclerosis, etc.) considering the risk of opioid withdrawal or reduced analgesia.
Prior/Ongoing Medications
* Currently receiving the first cycle of chemotherapy.
* Previously received naldemedine.
Other Exclusions
\- Positive pregnancy test for females of childbearing potential.
2 Years
18 Years
ALL
No
Sponsors
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Shionogi
INDUSTRY
Responsible Party
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Principal Investigators
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Shionogi Clinical Trials Administrator Clinical Support Help Line
Role: STUDY_DIRECTOR
Shionogi
Locations
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University Center Mother Theresa , Hospital - Onco-hematology department
Tirana, , Albania
Yeolyan Hematology. , and Oncology Center -
Yerevan, , Armenia
CHU Saint-Pierre Clinical Trials Unit
Brussels, , Belgium
Universitair Ziekenhuis Brussel (UZBrussel) - Department of Anesthesiology and Perioperative Medicine
Brussels, , Belgium
University Hospitals Leuven Pediatrisch hemato-oncology
Leuven, , Belgium
University Clinical Hospital , Mostar
Mostar, , Bosnia and Herzegovina
Chu de Caen
Caen, , France
Hôpital Béclère Service de Pédiatrie Centre de Référence des Maladies Héréditaires du Métabolisme Hépatique (CRMHMH)
Clamart, , France
Hôpital Jeanne de Flandre Antenne du CIC pédiatrique - Niveau 0 CHU de Lille
Lille, , France
Hôpital Armand Trousseau Service Hématologie et Oncologie Pédiatrique
Paris, , France
Instituto Nazionale dei Tumori
Milan, , Italy
Citta della Salute e della Scienza di Torino
Torino, , Italy
Maternal and Child Health Institute IRCCS Burlo Garofolo, Pain and pediatric palliative care service
Trieste, , Italy
National Center for Child Health and Development
Tokyo, , Japan
PHI University Clinic for Children's , Surgery
Skopje, , North Macedonia
University Clinic for Childrens Diseases , Department of Oncology, Hematology and , Malignant Hemopathy
Skopje, , North Macedonia
Countries
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Central Contacts
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Shionogi Clinical Trials Administrator Clinical Support Help Line
Role: CONTACT
Other Identifiers
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2019-003577-25
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
1907V921F
Identifier Type: -
Identifier Source: org_study_id
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