ONO-7847 Phase 3 Study

ONO-7847 Phase 3 Study, A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Examine the Efficacy and Safety of ONO-7847 for the Prevention of Cancer Chemotherapy-Induced Nausea and Vomiting in Patients with Malignant Tumor.

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080220800

Enrollment

344

Registered

2009-08-10

Start date

2009-08-10

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

Patient with Malignant Tumor

Interventions

investigational material(s) Generic name etc : ONO-7847 INN of investigational material : Therapeutic category code : 239 Other agents affecting digestive organs Dosage and Administration for Investi

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with malignant tumor who are to be intravenously administered cisplatin as a single dose of 70mg/m2 or higher within 3 hours 2.Patients whose performance status is 0 to 2

Exclusion criteria

Exclusion criteria: 1.In case of patients previously treated with cisplatin, those having no past history of vomiting as of administration of cisplatin

Design outcomes

Primary

Measure	Time frame
1.Proportion of patients with no vomiting and no use of rescue therapy (Complete Response) [Time Frame: 5 days] 2.Safety [Time Frame: 15 days]	—

Secondary

Measure	Time frame
1.Proportion of patients with CR in the acute phases (CR : Complete Response)[Time Frame: 1 day] 2.Proportion of patients with CR in the delayed phases (CR : Complete Response)[Time Frame: 4 days]	—

Outcome results

None listed

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