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DS-7113b extended-release tablet phase III study

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

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080222615
Enrollment
Unknown
Registered
2014-09-30
Start date
2014-09-30
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 ER tablet INN of investigational material : Hydromorphone hydrochloride Therapeutic category code : 811 Opium alkaloids preparations Dosage and

Sponsors

DAIICHISANKYO Co.,Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patients receiving non-opioid analgesics for cancer pain, who have not been receiving opioid analgesics 2) Patients whose VAS is  35 mm and judged necessary to be treated with strong opioid analgesics 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
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