A phase 3, multicenter, open-label study of naldemedine in patients with non-malignant chronic pain and opioid-induced constipation receiving S-8117 (Oxycodone hydrochloride hydrate)

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222556

Enrollment

Registered

2014-07-08

Start date

2014-07-08

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with non-malignant pain

Interventions

investigational material(s) Generic name etc : Naldemedine INN of investigational material : Naldemedine Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administrati

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion 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.

Exclusion criteria

Exclusion 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

Design outcomes

Primary

Measure	Time frame
Safety (Adverse events)	—

Secondary

Measure	Time frame
Efficacy (Proportion of SBM responders, Assessments of Constipation Symptoms and QOL, etc), pharmacokinetics	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026