A Phase 1 /2, Multicentre, Open-label Study of the Pharmacokinetics and Safety of Naldemedine in Paediatric Patients Receiving Opioids

A Phase 1 /2, Multicentre, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Naldemedine in Paediatric Patients Who Are Receiving or Who Are About to Receive Treatment with Opioids

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031250151

Enrollment

Registered

2025-06-05

Start date

2025-06-23

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

opioid-induced constipation

Interventions

Oral administration of naldemedine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients >= 2 years of age and < 18 years of age at the time of the signing of the informed consent form (ICF). - Patients with cancer or non-cancer pain who are receiving (or who are about to receive ) acute or chronic treatment with opioids. - Patients have either newly diagnosed constipation, a history of constipation treated with laxatives, or are expected to develop constipation after opioid treatment. - Patients are 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.

Exclusion criteria

Exclusion criteria: - Patients with a history of a gastrointestinal (GI) neoplasm or an ongoing GI-related issue or any recent (within last 1 year ) or planned GI tract surgery. - Patients with signs or symptoms of GI obstruction or patients with recurrent obstruction who may be at increased risk of GI perforation. - Patients who are unable to eat /swallow or have need of a nasogastric tube. - Patients who have reported no bowel movements for 7 consecutive days at the time of obtaining informed consent or on the initial day of study intervention administration (Study Day 1 ). - Patients with a history of more than 1 week of CTCAE Grade 3 neutropenia or thrombocytopenia with clinical sequelae. - Patients who need mechanical ventilation. - Patients who have severe CTCAE Grade 3 or above hepatic or renal impairment including end-stage renal disease requiring haemodialysis, as determined by the investigator. - Patients that have any progressive neurological disorders or potential disruption to the blood-brain barrier (e .g., primary brain malignancies, central nervous system metastases, active multiple sclerosis, etc. ) considering the risk of opioid withdrawal or reduced analgesia.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics parameters	—

Countries

Albania, Armenia, Belgium, Bosnia and Herzegovina, France, Italy, Japan, North Macedonia

Contacts

Public ContactCorporate Communications Department

Shionogi & Co., Ltd.

shionogiclintrials-admin@shionogi.co.jp+81-6-6209-7885

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026