Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids

Launched by SHIONOGI · Oct 18, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a medication called naldemedine to see how it works in children and teenagers who are experiencing constipation caused by opioid pain medications. Opioids can often lead to constipation, and this study aims to understand how naldemedine, when taken as a single dose, affects the body and helps with this issue. The trial is currently looking for participants aged 2 to 18 years who are receiving or about to start opioid treatment for pain, whether from cancer or other conditions.

To qualify for the study, participants should have either recently developed constipation, have a history of constipation that required treatment, or are likely to have constipation due to their opioid use. Participants will need to stay at the clinic for at least 12 hours after taking the medication for blood tests and return for additional tests after 24 hours. It's important to note that there are certain health conditions that would exclude someone from participating, such as ongoing gastrointestinal problems or recent surgeries. Overall, this trial could help improve how we manage constipation in young patients who need opioids for pain relief.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Disease Characteristics
• • 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:
• • Medical Conditions
• • 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.
• • Note: Other protocol-defined Inclusion/Exclusion criteria may apply.