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Tests treatment safety and results for Opioid-Induced Constipation (OIC)
Official title Safety and Pharmacokinetics Study of Naldemedine in Paediatric Participants Receiving Opioids
ClinicalTrials.gov ID: NCT05588323
What this study is testing
What is Naldemedine?
Naldemedine is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for opioid-induced constipation (oic).
Also referred to as Rizmoic.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The primary objective of this study is to evaluate the pharmacokinetic (PK) profile of naldemedine and nor-naldemedine after a single oral dose of naldemedine in pediatric participants who are receiving or about to receive opioids.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 18
You may be able to join if
- 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...
- 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...
- Body mass index within approximately the 3rd to 97th percentile for their age according to the World Health Organization Child Growth Standards.
You likely can't join if
- 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...
- History of more than 1 week of Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 neutropenia or thrombocytopenia with clinical sequelae.
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Tirana, Albania
- Yerevan, Armenia
- Brussels, Belgium
- Leuven, Belgium
- Mostar, Bosnia and Herzegovina
- Caen, France
- Clamart, France
- Lille, France
- Paris, France
- Milan, Italy
- Torino, Italy
- Trieste, Italy
- Tokyo, Japan
- Skopje, North Macedonia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tirana, Albania; Yerevan, Armenia; Brussels, Belgium; Leuven, Belgium; Mostar, Bosnia and Herzegovina; Caen, France and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.