Phase
Condition
Constipation
Treatment
Naldemedine
Clinical Study ID
Ages 2-18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Disease Characteristics
Participants with cancer or non-cancer pain who are receiving (or who are about toreceive) acute or chronic treatment with opioids.
Participants with either newly diagnosed constipation, a history of constipationtreated with laxatives, or are expected to develop constipation after opioidtreatment.
Able to remain in the clinic for blood sampling for at least 12 hours following thefirst 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 ageaccording to the World Health Organization Child Growth Standards.
Exclusion
Exclusion Criteria:
Medical Conditions
History of a gastrointestinal (GI) neoplasm or an ongoing GI-related issue or anyrecent (within last 1 year) or planned GI tract surgery.
Signs or symptoms of GI obstruction or participants with recurrent obstruction whomay 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 informedconsent 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 renaldisease requiring hemodialysis, as determined by the investigator.
Progressive neurological disorders or potential disruption to the blood-brainbarrier (for example, primary brain malignancies, central nervous system metastases,active multiple sclerosis, etc.) considering the risk of opioid withdrawal orreduced 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.
Study Design
Connect with a study center
University Center Mother Theresa , Hospital - Onco-hematology department
Tirana,
AlbaniaSite Not Available
Yeolyan Hematology. , and Oncology Center -
Yerevan,
ArmeniaActive - Recruiting
CHU Saint-Pierre Clinical Trials Unit
Brussels,
BelgiumCompleted
Universitair Ziekenhuis Brussel (UZBrussel) - Department of Anesthesiology and Perioperative Medicine
Brussels,
BelgiumCompleted
University Hospitals Leuven Pediatrisch hemato-oncology
Leuven,
BelgiumCompleted
University Clinical Hospital , Mostar
Mostar,
Bosnia and HerzegovinaActive - Recruiting
Chu de Caen
Caen, 14033
FranceCompleted
Hôpital Béclère Service de Pédiatrie Centre de Référence des Maladies Héréditaires du Métabolisme Hépatique (CRMHMH)
Clamart,
FranceCompleted
Hôpital Jeanne de Flandre Antenne du CIC pédiatrique - Niveau 0 CHU de Lille
Lille,
FranceCompleted
Hôpital Armand Trousseau Service Hématologie et Oncologie Pédiatrique
Paris,
FranceCompleted
Instituto Nazionale dei Tumori
Milan,
ItalyCompleted
Citta della Salute e della Scienza di Torino
Torino,
ItalyCompleted
Maternal and Child Health Institute IRCCS Burlo Garofolo, Pain and pediatric palliative care service
Trieste,
ItalyCompleted
National Center for Child Health and Development
Tokyo,
JapanSite Not Available
PHI University Clinic for Children's , Surgery
Skopje,
North MacedoniaActive - Recruiting
University Clinic for Childrens Diseases , Department of Oncology, Hematology and , Malignant Hemopathy
Skopje,
North MacedoniaActive - Recruiting
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.