A phase 3, multicenter, open-label study of naldemedine in cancer patients with opioid-induced constipation - extension study -

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222293

Enrollment

100

Registered

2013-11-15

Start date

2013-11-15

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

Cancer patients with opioid-induced constipation (OIC)

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 who participated in the phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of naldemedine in cancer patients with opioid-induced constipation and completed the treatment period, etc.

Exclusion criteria

Exclusion criteria: Patients with constipation potentially attributable to causes other than opioid analgesics Patients with hepatic or renal disorders, etc

Design outcomes

Primary

Measure	Time frame
Safety (Adverse events)	—

Secondary

Measure	Time frame
Efficacy (Assessments of Constipation Symptoms and QOL)	—

Outcome results

None listed

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