Long Term Safety of Naldemedine

Completed · Phase 3 · Has a placebo group

Conditions studied: Opioid-induced Constipation

In brief

The purpose of this study is to evaluate the long-term safety of naldemedine for the treatment of constipation due to opioid therapy.

Key facts

Study ID

NCT01965652

Run by

Shionogi

People needed

1246

Starts

2013-09-24

Expected to finish

2016-01-12

Last updated by the study team

2018-04-18

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects aged 18 to 80 years inclusive at the time of informed consent
• Subjects must have non-malignant chronic pain treated and must have opioid induced constipation (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

You may not qualify if…

• Evidence of significant structural abnormalities of the gastrointestinal (GI) tract
• 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 GI obstruction)
• Subjects who have never taken laxatives for the treatment of OIC
• Current use of any prohibited medication including opioid antagonists, partial or mixed agonists/antagonists

Where it is running

• Shionogi Research Site — Mobile, Alabama, United States
• Shionogi Research Site — Chandler, Arizona, United States
• Shionogi Research Site — Glendale, Arizona, United States
• Shionogi Research Site — Goodyear, Arizona, United States
• Shionogi Research Site — Mesa, Arizona, United States
• Shionogi Research Site — Phoenix, Arizona, United States
• Shionogi Research Site — Tucson, Arizona, United States
• Shionogi Research Site — Fountain Valley, California, United States
• Shionogi Research Site — Garden Grove, California, United States
• Shionogi Research Site — Glendale, California, United States
• Shionogi Research Site — Long Beach, California, United States
• Shionogi Research Site — Los Angeles, California, United States
• Shionogi Research Site — Oceanside, California, United States
• Shionogi Research Site — Sacramento, California, United States
• Shionogi Research Site — Santa Ana, California, United States
• Shionogi Research Site — Upland, California, United States
• Shionogi Research Site — Colorado Springs, Colorado, United States
• Shionogi Research Site — Boynton Beach, Florida, United States
• Shionogi Research Site — Brandon, Florida, United States
• Shionogi Research Site — Brooksville, Florida, United States
• Shionogi Research Site — Clearwater, Florida, United States
• Shionogi Research Site — Fort Myers, Florida, United States
• Shionogi Research Site — Jacksonville, Florida, United States
• Shionogi Research Site — Lake City, Florida, United States
• Shionogi Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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