A phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of naldemedine in cancer patients with opioid-induced constipation

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080222291

Enrollment

190

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: Cancer patients with 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.

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
The proportion of SBM responders Mean change in the frequency of SBM per week from baseline, adverse events, pharmacokinetics, etc	—

Outcome results

None listed

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