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New hope for kids on painkillers: constipation relief drug under study

NCT ID NCT05588323

Symptom relief Sponsor: Shionogi Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 29, 2026 · Updated 2 times

Summary

This study is testing a medicine called naldemedine to help children who get constipated from taking opioids (strong painkillers). About 24 children with cancer or other pain conditions will receive a single dose of the drug. Researchers will measure how the drug moves through the body and check for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 24 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2023

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 18 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

opioid-induced constipation

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Opioid-induced constipation (OIC)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    6 sites in 5 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHU Saint-Pierre Clinical Trials Unit

    COMPLETED

    Brussels, Belgium

  • Chu de Caen

    COMPLETED

    Caen, 14033, France

  • Citta della Salute e della Scienza di Torino

    COMPLETED

    Torino, Italy

  • Hôpital Armand Trousseau Service Hématologie et Oncologie Pédiatrique

    COMPLETED

    Paris, France

  • Hôpital Béclère Service de Pédiatrie Centre de Référence des Maladies Héréditaires du Métabolisme Hépatique (CRMHMH)

    COMPLETED

    Clamart, France

  • Hôpital Jeanne de Flandre Antenne du CIC pédiatrique - Niveau 0 CHU de Lille

    COMPLETED

    Lille, France

  • Instituto Nazionale dei Tumori

    COMPLETED

    Milan, Italy

  • Maternal and Child Health Institute IRCCS Burlo Garofolo, Pain and pediatric palliative care service

    COMPLETED

    Trieste, Italy

  • National Center for Child Health and Development

    NOT_YET_RECRUITING

    Tokyo, Japan

  • PHI University Clinic for Children's , Surgery

    RECRUITING

    Skopje, North Macedonia

  • Universitair Ziekenhuis Brussel (UZBrussel) - Department of Anesthesiology and Perioperative Medicine

    COMPLETED

    Brussels, Belgium

  • University Center Mother Theresa , Hospital - Onco-hematology department

    NOT_YET_RECRUITING

    Tirana, Albania

  • University Clinic for Childrens Diseases , Department of Oncology, Hematology and , Malignant Hemopathy

    RECRUITING

    Skopje, North Macedonia

  • University Clinical Hospital , Mostar

    RECRUITING

    Mostar, Bosnia and Herzegovina

  • University Hospitals Leuven Pediatrisch hemato-oncology

    COMPLETED

    Leuven, Belgium

  • Yeolyan Hematology. , and Oncology Center -

    RECRUITING

    Yerevan, Armenia

More trials for these conditions

Other studies related to the condition(s) this trial covers.