Randomised, double-blind, placebo-controlled, parallel-group design, multi-centre, dose-escalation phase III trial to investigate the efficacy, safety, and tolerability of Naloxone HCl PR tablets administered in a dose range of 6 mg to 48 mg once daily in patients with opioid induced constipation

Develco Pharma Schweiz AG0 sites306 target enrollmentFebruary 10, 2014

ConditionsOpioid-induced bowel dysfunction (OBD) involves not only constipation, but also a constellation of symptoms including incomplete evacuation, bloating, abdominal distension, and increased gastric reflux.Constipation is an almost inevitable consequence of opioid use in malignant and non-malignant disease states, and one of the side effects of opioids to which few patients develop tolerance.MedDRA version: 16.1Level: LLTClassification code 10071128Term: Opioid induced constipationSystem Organ Class: 100000004856 Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Opioid-induced bowel dysfunction (OBD) involves not only constipation, but also a constellation of symptoms including incomplete evacuation, bloating, abdominal distension, and increased gastric reflux.Constipation is an almost inevitable consequence of opioid use in malignant and non-malignant disease states, and one of the side effects of opioids to which few patients develop tolerance.
Sponsor: Develco Pharma Schweiz AG
Enrollment: 306
Status: Active, not recruiting
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

February 10, 2014

End Date

TBD

Last Updated

10 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Develco Pharma Schweiz AG

Eligibility Criteria

Inclusion Criteria

•1\. Male and female subjects \=18 years of age.
•2\. Subjects with a documented history of constipation induced or worsened by their oral, transdermal or sublingual WHO step\-II or step\-III opioid medication.
•3\. Requirement of laxatives to have bowel movements (BMs), or having less than 3 BMs per week when not taking laxatives, respectively.
•4\. Subjects with documented history of chronic severe non\-malignant pain that requires around\-the\-clock opioid therapy and likely to benefit from WHO step\-III opioid therapy for the duration of the trial.
•5\. Subjects with predominantly non\-neuropathic pain, as determined by a DN4 Neuropathic Pain Diagnostic Questionnaire score \< 4 .
•6\. Subjects willing and able (e.g. mental and physical condition) to participate in all aspects of the trial, including use of medication, completion of subjective evaluations, attending scheduled visits, completing telephone interviews, and compliant with protocol requirements as evidenced by providing signed written informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 200

Exclusion Criteria

•1\. Subjects with any situation in which opioids are contra\-indicated, severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive pulmonary disease, cor pulmonale, severe bronchial asthma, paralytic ileus.
•2\. Hypersensitivity or intolerance to any active substance, i.e. oxycodone, hydromorphone, morphine, naloxone, bisacodyl, or any of the excipients of the trial medication, e.g. subjects with hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose\-galactose malabsorption.
•3\. Intake of naloxone or naltrexone or injection of methylnaltrexone within the past 30 days prior to Visit 1\.
•4\. Subjects unwilling to discontinue pre\-trial laxative medication (except fibre supplementation or bulking agents at a stable dose) and take trial specific laxative medication.
•5\. Any gastrointestinal pathology or surgery or intractable vomiting likely to significantly influence drug absorption.
•6\. Inability to swallow the trial drugs whole (e.g. due to dysphagia).
•7\. Surgery within 1 month, radiotherapy or neural blockade 2 weeks prior to Visit 1 and/or anticipated and/or scheduled during the course of the trial.
•8\. Evidence of impaired hepatic function (total bilirubin, aspartate aminotransferase \[AST], alanine aminotransferase \[ALT], gamma\-glutamyltransferase \[GGT], or alkaline phosphatase \[AP] \>3 times the upper limit of normal).
•9\. Evidence of moderate or severe renal function impairment (creatinine clearance \[CRCL] \<60 mL/min).
•10\. Known or suspected significant hypotension, shock or severe cardiovascular disease.