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

Completed · Phase 2 · Has a placebo group

Conditions studied: Opioid-induced Constipation

In brief

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.

Key facts

Study ID

NCT01443403

Run by

Shionogi

People needed

244

Starts

2011-08-17

Expected to finish

2012-08-22

Last updated by the study team

2017-06-26

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Shionogi Research Site — Phoenix, Arizona, United States
• Shionogi Research Site — Sun Lakes, Arizona, United States
• Shionogi Research Site — Little Rock, Arkansas, United States
• Shionogi Research Site — Anaheim, California, United States
• Shionogi Research Site — Fresno, California, United States
• Shionogi Research Site — Lincoln, California, United States
• Shionogi Research Site — Lomita, California, United States
• Shionogi Research Site — Denver, Colorado, United States
• Shionogi Research Site — Brandon, Florida, United States
• Shionogi Research Site — Kissimmee, Florida, United States
• Shionogi Research Site — New Port Richey, Florida, United States
• Shionogi Research Site — North Miami, Florida, United States
• Shionogi Research Site — Ocala, Florida, United States
• Shionogi Research Site — Orlando, Florida, United States
• Shionogi Research Site — Ormond Beach, Florida, United States
• Shionogi Research Site — Port Orange, Florida, United States
• Shionogi Research Site — Sarasota, Florida, United States
• Shionogi Research Site — South Miami, Florida, United States
• Shionogi Research Site — West Palm Beach, Florida, United States
• Shionogi Research Site — Atlanta, Georgia, United States
• Shionogi Research Site — Decatur, Georgia, United States
• Shionogi Research Site — Marietta, Georgia, United States
• Shionogi Research Site — Evansville, Indiana, United States
• Shionogi Research Site — Lexington, Kentucky, United States
• Shionogi Research Site — Shreveport, Louisiana, United States

Full record on ClinicalTrials.gov

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