NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-142443

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedNon-malignant pain and OIC
Date of first enrollment
Target sample size40
Countries of recruitment
Study typeINTERVENTIONAL
Intervention(s)Intervention name : Naldemedine INN of the intervention : Naldemedine Dosage And administration of the intervention : Oral Control intervention name : null

Outcome(s)

Primary OutcomeSafety (Adverse events)
Secondary OutcomeEfficacy (Proportion of SBM responders, Assessments of Constipation Symptoms and QOL, etc), pharmacokinetics

Key inclusion & exclusion criteria

Age minimum20
Age maximum
GenderBOTH
Include criteriaPatients with non-malignant pain and constipation associated with administration of opioid analgesics who meet the following criteria: Patients whose SBM (spontaneous bowel movement) frequency per week is less than three times, and who experience at least one of the following symptoms of bowel movements 1. Straining during bowel movement 2. Feeling of incomplete evacuation 3. Passage of hard stools or pellets etc.
Exclude criteriaPatients with constipation potentially attributable to causes other than opioid analgesics Patients with hepatic or renal disorders, etc

Related Information

Contact

public contact
Name Shionogi & Co., Ltd. Corporate Communications Department
Address http://www.shionogi.co.jp/information/inquiry_entrance.html
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scientific contact
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