A Phase IIb, Randomized, Double-blind, Placebo-controlled, Parallel Group Study of S-297995 for the Treatment of Opioid-induced Constipation (OIC) in Cancer Patients

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221471

Enrollment

212

Registered

2011-05-31

Start date

2011-05-31

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 constipation associated with administration of opioid analgesics

Interventions

investigational material(s) Generic name etc : S-297995 INN of investigational material : Naldemedine Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration

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 is less than three times per week during the 14 days prior to enrollment, 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 change in the frequency of SBM per week from baseline	—

Secondary

Measure	Time frame
The proportion of SBM responders, adverse events, pharmacokinetics, etc	—

Outcome results

None listed

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