ONO-3849 Phase II Study

A Multicenter open-labeled uncontrolled study in patients with Opioid-Induced Constipation

Status

Unknown

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221726

Enrollment

Registered

2012-02-29

Start date

2012-02-29

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

Opioid-induced constipation

Interventions

investigational material(s) Generic name etc : ONO-3849 INN of investigational material : methylnaltrexone bromide Therapeutic category code : 235 Purgatives and clysters Dosage and Administration for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Age 20 years or older. 2.Patient with constipation on a stable opioid regimen.

Exclusion criteria

Exclusion criteria: 1.Patients with known or suspected gastrointestinal obstruction. 2.Patients with constipation mainly caused by any bowel dysfunction other than opioid-induced one.

Design outcomes

Primary

Measure	Time frame
Laxation response rate within 4 hours of study drug treatment without rescue laxatives.	—

Secondary

Measure	Time frame
Laxation response rate within 24 hours of study drug treatment without rescue laxatives, and so on.	—

Outcome results

None listed

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