Overview

A Study of Naldemedine (S-297995) for the Treatment of Opioid-Induced Constipation in Adults With Non-Malignant Chronic Pain Receiving Opioid Therapy

Status:
Completed
Trial end date:
2012-08-22
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to determine efficacy and safety of naldemedine for the treatment of opioid-induced constipation in adults with non-malignant chronic pain receiving opioid therapy for ≥ 3 months.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Shionogi
Treatments:
Analgesics, Opioid
Criteria
Inclusion Criteria:

- Subjects aged 18 years or older at time of informed consent with non-malignant chronic
pain experiencing opioid-induced constipation

- Subjects with < 3 spontaneous bowel movements a week and experiencing bowel symptoms

- Subjects receiving chronic opioid therapy due to non-malignant pain for ≥ 3 months

Exclusion Criteria:

- Evidence of clinically significant gastrointestinal disease

- 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

- Severe constipation that has not been appropriately managed such that the subject is
at immediate risk of developing serious complications of constipation