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DS-7113b injection phase II/III study (intravenous administration)

DS-7113b injection phase II/III study An open label and extension study of DS-7113 injection in patients with cancer pain (intravenous administration)

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222684
Enrollment
Unknown
Registered
2014-12-09
Start date
2014-12-09
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 injection (intravenous administration) INN of investigational material : Hydromorphone hydrochloride Therapeutic category code : 811 Opium alkal

Sponsors

DAIICHISANKYO Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients who can be hospitalized during a dosage period, and secure a route to carry out intravenous administration 2) Patients receiving analgesics for cancer pain 3) Patients with an ECOG Performance Status (PS) is =< 3, etc.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Response rate by Day 7 (analgesia improvement rate)—

Secondary

MeasureTime frame
Change of pain intensity (PI) and VAS, efficacy and safety—

Outcome results

None listed

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