Clinical research study to assess if naldemedine is safe and tolerable whenadmininstered to paediatric patients (patients under the age of 18) whoare receiving or about to receive treatment with a class of drugs called opioids
- Conditions
- Opioid induced constipationTherapeutic area: Diseases [C] - Digestive System Diseases [C06]MedDRA version: 24.0Level: LLTClassification code 10071128Term: Opioid induced constipationSystem Organ Class: 10017947 - Gastrointestinal disorders
- Registration Number
- EUCTR2019-003577-25-BE
- Lead Sponsor
- Shionogi B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 24
1. Patients = 2 years of age and < 18 years of age at the time of the signing of the informed consent form.
2. Patients with cancer or non-cancer pain who are receiving (or who are about to receive) acute or chronic treatment with opioids
3. Have either newly diagnosed constipation, a history of constipation treated with laxatives, or expected to develop constipation after opioid treatment.
4. Patients able to remain in the clinic for blood sampling for at least 12 hours following the first study intervention dose and able to return for blood sampling at the 24-hour time point.
5. Patients able to comply with meal, tobacco, and concomitant medication restrictions
6. BMI within approximately the 3rd to 97th percentile for their age according to the World Health Organization (WHO) Child Growth Standard
7 a. Male Patients: Based on the Clinical Trials Facilitation and Coordination Group (CTFG) guidance, no contraception measures are required for male patients because naldemedine is not genotoxic and is categorized ‘unlikely’ for the risk of human teratogenicity/foetotoxicity.
7 b. Female patients: A female patient is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
- Is a woman of nonchildbearing potential (WONCBP)
OR
- Is a woman of childbearing potential (WOCBP) and using an
acceptable contraceptive method as described in protocol, during the treatment period and for 30 days following the last dose of study drug . The investigator should evaluate the potential for contraceptive method failure (eg. noncompliance, recently initiated) in relationship to the first dose of study drug.
- A WOCBP must have a negative highly sensitive pregnancy test (urine or
serum as required by local regulations) at screening and within 24 hours of
the first dose of naldemedine.
- If a urine test cannot be confirmed as negative (e.g., an ambiguous
result), a serum pregnancy test is required. In such cases, the patient
must be excluded from participation if the serum pregnancy result is
positive.
- Additional requirements for pregnancy testing during and after study
intervention as per protocol.
8. Each patient’s parent/legal guardian must be capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Are the trial subjects under 18? yes
Number of subjects for this age range: 24
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range 0
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0
1. Patients with a history of a GI neoplasm or an ongoing GI-related issue or any
recent (within last 1 year) or planned GI tract surgery
2. Patients with signs or symptoms of GI obstruction or patients with recurrent obstruction who may be at increased risk of GI perforation.
3. Patients who are unable to eat/swallow or have need of a nasogastric tube.
4. Patients who have reported no bowel movements for 7 consecutive days at the time of obtaining informed consent or on the initial day of study intervention administration (Study Day 1)
5. Patients with a history of more than 1 week of CTCAE Grade 3 neutropenia or
thrombocytopenia with clinical sequelae
6. Patients who need mechanical ventilation
7. Patients who have severe CTCAE Grade 3 or above hepatic or renal impairment including end-stage renal disease requiring haemodialysis, as determined by the investigator
8. Patients that have any progressive neurological disorders or potential disruption to the blood-brain barrier (e.g., primary brain malignancies, CNS metastases, active multiple sclerosis, etc.) considering the risk of opioid withdrawal or reduced analgesia.
9. Patients who have a history of hypersensitivity to naldemedine or any of its ingredients.
10. Patients who have previously received naldemedine.
11. Patients currently receiving their first cycle of chemotherapy
12. Patients currently participating in another study of an investigational drug product or have received another investigational drug product within 30 days or 5 half-lives, whichever is longer, before baseline
13. Positive pregnancy test for female patients of childbearing potential
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method