Clinical trial to investigate the bioavailability of Naloxone in children with opioid induced constipatio

Phase 1

• Conditions: Opioid induced constipation; MedDRA version: 20.0Level: LLTClassification code 10071128Term: Opioid induced constipationSystem Organ Class: 100000004856; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

• Registration Number: EUCTR2015-002310-72-DE
• Lead Sponsor: Develco Pharma Schweiz AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-28
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

-Male and female paediatric patients, from 4 years (provided that they are able to swallow the tablet) to less than 18 years of age.

-Subjects with malignant or non-malignant pain who are requiring (or are about to require) short-term or long-term treatment with opioids (i.e. start of opioid treatment on the day of screening at the latest).

-In the investigator’s judgement, subjects must be either newly diagnosed with OIC or subjects must have a history of OIC treated with laxatives or are expected to develop constipation after initiation of opioid treatment.

-Female subjects of childbearing potential (postmenarchal) must have a negative urine pregnancy test at screening. Females of childbearing potential must either not be sexually active or be using an adequate birth control method throughout the duration of the study.

Are the trial subjects under 18? yes
Number of subjects for this age range: 72
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Currently active medical conditions or ongoing treatments (e.g. irinotecan or any other chemotherapy) that may result in diarrhoea or intermittent loose stools or intractable vomiting during the screening or treatment period.

- Evidence of impaired hepatic function (total bilirubin, aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transferase (GGT), or alkaline phosphatase (AP) >3 times the upper limit of normal, unless known to be due to Gilbert’s syndrome or sickle-cell disease).

- Evidence of impaired renal function (glomerular filtration rate [GFR] <60 mL/min/1.73 m2, using the updated bedside Schwartz formula) or subjects with renal failure who are on any form of dialysis.

- Any suspected or known physiologic, neurogenic, endocrinic, metabolic, anatomic or other causes of constipation, such as functional constipation, Hirschsprung’s disease, spinal or anal/rectal abnormalities, inflammatory bowel diseases, gastrointestinal perforation or obstruction, other drugs or any gastrointestinal pathology or surgery, likely to significantly influence drug absorption. Faecal impaction at screening.

- Pregnancy or breast-feeding.

- Any other condition of the subject that, in the opinion of the investigator, may compromise evaluation of the trial treatment or jeopardize subject’s safety, compliance or adherence to protocol requirements.

- Administration of any other investigational products, currently or within the last 30 days, unless it is a labelled therapy (adult or paediatric), which is not expected to interfere with the pharmacokinetics/drug absorption of NLX HCl PR tablets.

- Employees of the investigator, trial centre, sponsor, CRO and trial consultants, when employees are directly involved in the trial or other studies under the direction of this investigator or trial centre, and their family members.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified