NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Patients with non-malignant pain
Date of first enrollment	08/07/2014
Target sample size	10
Countries of recruitment
Study type	Interventional
Intervention(s)	investigational material(s) Generic name etc : Naldemedine INN of investigational material : Naldemedine Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Investigational material : Oral Generic name etc : S-8117 INN of investigational material : Therapeutic category code : 811 Opium alkaloids preparations Dosage and Administration for Investigational material : Oral

Outcome(s)

Primary Outcome	Safety (Adverse events)
Secondary Outcome	Efficacy (Proportion of SBM responders, Assessments of Constipation Symptoms and QOL, etc), pharmacokinetics

Key inclusion & exclusion criteria

Age minimum	>= 20age old
Age maximum	<= 79age old
Gender	Both
Include criteria	Patients with non-malignant pain who meet the following criteria: Patients who initiated to receive S-8117 for treatment of non-malignant chronic pain and confirmed the occurrence of OIC 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 a) Straining during bowel movement b) Feeling of incomplete evacuation c) Passage of hard stools or pellets etc.
Exclude criteria	Patients with constipation potentially attributable to causes other than opioid analgesics Patients with significant gastrointestinal disorders Patients with previous or present allergy or hypersensitivity to opium alkaloids Patients with hepatic or renal disorders, etc