Evaluating the safety and effects of naldemedine in children using opioids

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the pharmacokinetic profile of naldemedine and its metabolite, nor-naldemedine, after a single oral dose in pediatric patients who are currently receiving or about to receive opioid treatment. The trial focuses on children with cancer or non-cancer pain who are at risk of developing opioid-induced constipation. Participants will be monitored for their ability to remain in the clinic for blood sampling for pharmacokinetic analysis over a 24-hour period following the dose. The study is designed to gather important safety and efficacy data for this population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Yeolyan Hematology. , and Oncology Center -
  Yerevan, Armenia Recruiting
• University Clinical Hospital , Mostar
  Mostar, Bosnia and Herzegovina Recruiting
• PHI University Clinic for Children's , Surgery
  Skopje, North Macedonia Recruiting
• University Clinic for Childrens Diseases , Department of Oncology, Hematology and , Malignant Hemopathy
  Skopje, North Macedonia Recruiting
• University Center Mother Theresa , Hospital - Onco-hematology department
  Tirana, Albania Not yet recruiting
• CHU Saint-Pierre Clinical Trials Unit
  Brussels, Belgium Completed

Study contacts

• Study coordinator: Shionogi Clinical Trials Administrator Clinical Support Help Line
• Email: Shionogiclintrials-admin@shionogi.co.jp
• Phone: 800-849-9707

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Naldemedine for opioid-induced constipation in people with cancer

  This study will try naldemedine, a gut-acting opioid blocker, to relieve opioid-induced constipation in adults with cancer who still have constipation despite laxatives.

  Recruiting Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) · Amsterdam · NCT07231796

• Assessing cardiovascular risks of naldemedine and other medications for opioid-induced constipation

  This study is testing whether using naldemedine for opioid-induced constipation has different heart risks compared to other medications like lubiprostone and naloxegol.

  Recruiting BioDelivery Sciences International · Wilmington, Delaware · NCT03720613

• Preventing constipation caused by opioids in advanced cancer patients

  This study is testing whether magnesium hydroxide can help prevent constipation caused by opioid pain medications in advanced cancer patients better than a standard treatment.

  Recruiting at 13 sites Phase 4 Amsterdam UMC, location VUmc · Almere Stad, Flevoland and 12 other locations · NCT05216328

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.