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; MedDRA version: 17.1Level: LLTClassification code 10071128Term: Opioid induced constipationSystem Organ Class: 100000004856; Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11-19
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1200

Inclusion Criteria

1. Subjects aged 18 to 80 years inclusive at the time of informed consent
2. Subjects must have non-malignant chronic pain and must have OIC
3. Subjects must be treated with a stable opioid regimen at a total daily dose on average of = 30 mg equivalents of oral morphine sulfate
4. 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 600
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 600

Exclusion Criteria

1. 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
2. Evidence of active medical diseases affecting bowel transit
3. History of pelvic disorders that may be a cause of constipation
4. Surgery (except for minor procedures) within 60 days of Screening
5. 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)
6. Subjects who have never taken laxatives for the treatment of OIC
7. Current use of any prohibited medication listed 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 assess the long-term safety of naldemedine for the treatment of constipation due to opioid therapy ;Secondary Objective: To assess specific effects of naldemedine as detailed in the study<br>protocol;Primary end point(s): Safety: The incidence of TEAEs, SAEs, and AEs leading to discontinuation.;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