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DS-7113b phase II study

DS-7113b phase II study -A DS-7113b potency ratio assessment study in patients with cancer pain.-

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222120
Enrollment
Unknown
Registered
2013-06-19
Start date
2013-06-19
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

Moderate to severe cancer pain

Interventions

investigational material(s) Generic name etc : DS-7113b INN of investigational material : Hydromorphone hydrochloride Therapeutic category code : 811 Opium alkaloids preparations Dosage and Administra

Sponsors

DAIICHISANKYO Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: -Patients with cancer pain whose pain is controlled by steady dose of an oral morphine during the screening period. -Patients whose frequency of rescue dose during the screening period is within the specified number. -Patients with an ECOG PS of =<3, etc.

Exclusion criteria

Exclusion criteria: Patients with symptom(s)/finding(s) falling under the contraindications or relative contraindications stated in the package insert of oral morphine preparations, etc.

Design outcomes

Primary

MeasureTime frame
Pain control achievement rates—

Secondary

MeasureTime frame
Efficacy rate at completion of study treatment, efficacy and safety—

Outcome results

None listed

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