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DS-7113b phase III study

DS-7113b phase III study A randomized double-blind comparison study with immediate release (IR) oxycodone in opioid-naive patients with cancer pain

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222289
Enrollment
Unknown
Registered
2013-11-14
Start date
2013-11-14
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 receiving non-opioid analgesics for cancer pain, who have not been receiving opioid analgesics - Patients whose VAS is >= 35 mm and judged necessary to be treated with strong opioid analgesics - 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 oxycodone hydrochloride powder and morphine hydrochloride preparations, etc.

Design outcomes

Primary

MeasureTime frame
Change of VAS between pre-treatment and end of treatment—

Secondary

MeasureTime frame
Response rate at end of treatment (analgesia improvement rate), efficacy and safety—

Outcome results

None listed

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