ong-term Safety Study of Naldemedine for the Treatment of Opioid-induced Constipation in Subjects with Non-malignant Chronic Pain Receiving Opioid Therapy

Phase 1

• Conditions: Opioid-induced Constipation in Subjects with Non-malignant Chronic Pain Receiving Opioid Therapy; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]; MedDRA version: 16.1Level: LLTClassification code 10071128Term: Opioid induced constipationSystem Organ Class: 100000004856

• Registration Number: EUCTR2013-002949-11-ES
• Lead Sponsor: Shionogi Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-17
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1500

Inclusion Criteria

- Subjects aged 18 to 80 years inclusive at the time of informed consent
- Subjects must have non-malignant chronic pain and must have OIC
- Subjects must be treated with a stable opioid regimen at a total daily dose on average of ? 30 mg equivalents of oral morphine sulfate
- Subjects may or may not be on a routine laxative regimen at the time of Screening
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 750
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 750

Exclusion Criteria

- Evidence of significant structural abnormalities of the gastrointestinal (GI) tract
a. history of bowel obstructions, strictures
b. history of bowel surgery such as bowel resection or bariatric surgeries
- Evidence of active medical diseases affecting bowel transit
- History of pelvic disorders that may be a cause of constipation
- Surgery (except for minor procedures) within 60 days of Screening
- History of chronic constipation prior to starting analgesic medication or any potential non-opioid cause of bowel dysfunction that may be a major contributor to the constipation (e.g. mechanical gastrointestinal obstruction)
- Subjects who have never taken laxatives for the treatment of OIC
- Current use of any prohibited medication including opioid antagonists, partial agonists or mixed opioid
agonists/antagonists

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy;Secondary Objective: - To evaluate the overall safety and tolerability of naldemedine;Primary end point(s): The primary safety endpoint is the number of Major Adverse Cardiac Events (MACE) during a 52-week Treatment Period;Timepoint(s) of evaluation of this end point: Week 52

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To evaluate the overall safety and tolerability of naldemedine;Timepoint(s) of evaluation of this end point: WK 52